1,564 results on '"Prostate disease"'
Search Results
52. The role of Cucurbita pepo in the management of patients affected by lower urinary tract symptoms due to benign prostatic hyperplasia: A narrative review
- Author
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Rocco Damiano, Tommaso Cai, Paolo Fornara, Corrado Antonio Franzese, Rosario Leonardi, and Vincenzo Mirone
- Subjects
BPH ,Cucurbita pepo ,LUTS ,Prostate disease ,Pumpkin seed ,Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
Objective: Phytotherapeutic compounds are largely used in the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) due to low side-effect profiles and costs, high level of acceptance by patients and a low rate of dropout. Here, we aimed to analyze all available evidence on the role of Cucurbita pepo in the treatment of LUTS-BPH. Material and methods: In May 2016 a systematic search was carried out thorough National Library of Medicine Pubmed, Scopus database and the ISI Web of Knowledge official website in order to identify all published studies on Cucurbita pepo and BPH. The following search strings were used: “Cucurbita pepo” OR “pumpkin seed” AND “prostate”; “Cucurbita pepo” AND “antiandrogen” OR “antiproliferative” OR “anti-inflammatory” OR “antioxidant activities”; “cucurbita pepo” OR “pumpkin seed” AND “LUTS” AND “symptoms improvement” OR “quality of life”. We consider for the present analysis only studies related to LUTS-BPH. Results: Among all 670 screened, 16 were related to LUTSBPH and finally analyzed. Among all, ten of them were performed in “in vitro setting” showing anti-inflammatory and antiandrogen effect, and a reduction in prostate growth and detrusor activity, while six were clinical studies. In all studies an improvement in International Prostatic Symptoms Score (IPSS) and uroflowmetry parameters has been reported. In 4 studies, an improvement in quality of life has been reported. Conclusion: On the basis of our narrative review, the use of Cucurbita pepo in the management of patients affected by LUTS-BPH seems to be useful for improving symptoms and quality of life. However, future clinical trials are requested to confirm these promising results.
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- 2016
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- View/download PDF
53. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death: a prospective Scandinavian cohort study
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Mats Steinholtz Ahlberg, Hans Garmo, Hans-Olov Adami, Ove Andrén, Jan-Erik Johansson, Gunnar Steineck, Lars Holmberg, and Anna Bill-Axelson
- Subjects
Male ,Prostatectomy ,Cancer och onkologi ,Epidemiology ,Urological tumours ,Prostatic Neoplasms ,Margins of Excision ,General Medicine ,Prostate-Specific Antigen ,Cohort Studies ,Prostate disease ,Cancer and Oncology ,Urologi och njurmedicin ,Urology and Nephrology ,Humans ,Prospective Studies ,Neoplasm Recurrence, Local ,Aged - Abstract
ObjectiveAlthough surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy.DesignProspective cohort study. Stratification by Gleason score (≤3+4=7 or ≥4+3=7), pathological tumour stage (pT2 or ≥pT3) and negative or positive surgical margins.SettingBetween 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1 year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6 weeks from surgery (n=3).Primary outcome measuresCumulative incidences and absolute differences in metastatic disease and prostate cancer death.ResultsWe analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8 ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score ≤3+4=7 and 57% among men with Gleason score ≥4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT ≥3 versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort.ConclusionMany patients with favourable histopathology without biochemical recurrence 5 years after radical prostatectomy could stop follow-up earlier than 10 years after radical prostatectomy.
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- 2022
54. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death : a prospective Scandinavian cohort study
- Abstract
Objective: Although surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy. Design: Prospective cohort study. Stratification by Gleason score (<= 3+4=7or >= 4+3=7), pathological tumour stage (pT2 or >= pT3) and negative or positive surgical margins. Setting: Between 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6weeks from surgery (n=3). Primary outcome measures: Cumulative incidences and absolute differences in metastatic disease and prostate cancer death. Results: We analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score <= 3+4=7and 57% among men with Gleason score >= 4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT >= 3versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort. Conclusion: Many patients with favourable histopathology without bio
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- 2022
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- View/download PDF
55. Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy:study protocol
- Abstract
INTRODUCTION: Blood cholesterol is likely a risk factor for prostate cancer prognosis and use of statins is associated with lowered risk of prostate cancer recurrence and progression. Furthermore, use of statins has been associated with prolonged time before development of castration resistance (CR) during androgen deprivation therapy (ADT) for prostate cancer. However, the efficacy of statins on delaying castration-resistance has not been tested in a randomised placebo-controlled setting.This study aims to test statins' efficacy compared to placebo in delaying development of CR during ADT treatment for primary metastatic or recurrent prostate cancer. Secondary aim is to explore effect of statin intervention on prostate cancer mortality and lipid metabolism during ADT. METHODS AND ANALYSIS: In this randomised placebo-controlled trial, a total of 400 men with de novo metastatic prostate cancer or recurrent disease after primary treatment and starting ADT will be recruited and randomised 1:1 to use daily 80 mg of atorvastatin or placebo. All researchers, study nurses and patients will be blinded throughout the trial. Patients are followed until disease recurrence or death. Primary outcome is time to formation of CR after initiation of ADT. Serum lipid levels (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and trigyserides) are analysed to test whether changes in serum cholesterol parameters during ADT predict length of treatment response. Furthermore, the trial will compare quality of life, cardiovascular morbidity, changes in blood glucose and circulating cell-free DNA, and urine lipidome during trial. ETHICS AND DISSEMINATION: This study is approved by the Regional ethics committees of the Pirkanmaa Hospital District, Science centre, Tampere, Finland (R18065M) and Tarto University Hospital, Tarto, Estonia (319/T-6). All participants read and sign informed consent form before study entry. After publication of results for the prima
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- 2022
56. Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy:study protocol
- Abstract
INTRODUCTION: Blood cholesterol is likely a risk factor for prostate cancer prognosis and use of statins is associated with lowered risk of prostate cancer recurrence and progression. Furthermore, use of statins has been associated with prolonged time before development of castration resistance (CR) during androgen deprivation therapy (ADT) for prostate cancer. However, the efficacy of statins on delaying castration-resistance has not been tested in a randomised placebo-controlled setting.This study aims to test statins' efficacy compared to placebo in delaying development of CR during ADT treatment for primary metastatic or recurrent prostate cancer. Secondary aim is to explore effect of statin intervention on prostate cancer mortality and lipid metabolism during ADT. METHODS AND ANALYSIS: In this randomised placebo-controlled trial, a total of 400 men with de novo metastatic prostate cancer or recurrent disease after primary treatment and starting ADT will be recruited and randomised 1:1 to use daily 80 mg of atorvastatin or placebo. All researchers, study nurses and patients will be blinded throughout the trial. Patients are followed until disease recurrence or death. Primary outcome is time to formation of CR after initiation of ADT. Serum lipid levels (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and trigyserides) are analysed to test whether changes in serum cholesterol parameters during ADT predict length of treatment response. Furthermore, the trial will compare quality of life, cardiovascular morbidity, changes in blood glucose and circulating cell-free DNA, and urine lipidome during trial. ETHICS AND DISSEMINATION: This study is approved by the Regional ethics committees of the Pirkanmaa Hospital District, Science centre, Tampere, Finland (R18065M) and Tarto University Hospital, Tarto, Estonia (319/T-6). All participants read and sign informed consent form before study entry. After publication of results for the prima
- Published
- 2022
57. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death : a prospective Scandinavian cohort study
- Abstract
Objective: Although surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy. Design: Prospective cohort study. Stratification by Gleason score (<= 3+4=7or >= 4+3=7), pathological tumour stage (pT2 or >= pT3) and negative or positive surgical margins. Setting: Between 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6weeks from surgery (n=3). Primary outcome measures: Cumulative incidences and absolute differences in metastatic disease and prostate cancer death. Results: We analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score <= 3+4=7and 57% among men with Gleason score >= 4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT >= 3versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort. Conclusion: Many patients with favourable histopathology without bio
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- 2022
- Full Text
- View/download PDF
58. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death : a prospective Scandinavian cohort study
- Abstract
Objective: Although surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy. Design: Prospective cohort study. Stratification by Gleason score (<= 3+4=7or >= 4+3=7), pathological tumour stage (pT2 or >= pT3) and negative or positive surgical margins. Setting: Between 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6weeks from surgery (n=3). Primary outcome measures: Cumulative incidences and absolute differences in metastatic disease and prostate cancer death. Results: We analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score <= 3+4=7and 57% among men with Gleason score >= 4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT >= 3versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort. Conclusion: Many patients with favourable histopathology without bio
- Published
- 2022
- Full Text
- View/download PDF
59. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death : a prospective Scandinavian cohort study
- Abstract
Objective: Although surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy. Design: Prospective cohort study. Stratification by Gleason score (<= 3+4=7or >= 4+3=7), pathological tumour stage (pT2 or >= pT3) and negative or positive surgical margins. Setting: Between 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6weeks from surgery (n=3). Primary outcome measures: Cumulative incidences and absolute differences in metastatic disease and prostate cancer death. Results: We analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score <= 3+4=7and 57% among men with Gleason score >= 4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT >= 3versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort. Conclusion: Many patients with favourable histopathology without bio
- Published
- 2022
- Full Text
- View/download PDF
60. Time without PSA recurrence after radical prostatectomy as a predictor of future biochemical recurrence, metastatic disease and prostate cancer death : a prospective Scandinavian cohort study
- Abstract
Objective: Although surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy. Design: Prospective cohort study. Stratification by Gleason score (<= 3+4=7or >= 4+3=7), pathological tumour stage (pT2 or >= pT3) and negative or positive surgical margins. Setting: Between 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6weeks from surgery (n=3). Primary outcome measures: Cumulative incidences and absolute differences in metastatic disease and prostate cancer death. Results: We analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score <= 3+4=7and 57% among men with Gleason score >= 4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT >= 3versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort. Conclusion: Many patients with favourable histopathology without bio
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- 2022
- Full Text
- View/download PDF
61. Weight loss for overweight and obese patients with prostate cancer: A study protocol of a randomised trial comparing clinic-based versus telehealth delivered exercise and nutrition intervention (the TelEX trial)
- Abstract
Introduction Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer. Methods and analysis A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥ 25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7-12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches. Ethics and dissemination Ethics approval has been obtained from the Edith Cowa
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- 2022
62. Evaluating a multicomponent survivorship programme for men with prostate cancer in Australia: A single cohort study
- Abstract
Objective: To evaluate the implementation of a multicomponent survivorship programme for men with prostate cancer and their carers. Design: A single cohort study, guided by the RE-AIM framework. Setting: Multiple health services in Australia. Participants: Men with prostate cancer and their carers, and health professionals. Intervention: A 12-month telehealth programme that provided centralised and coordinated decision and information support, exercise and nutrition management, specialised clinical support and practical support to men and their carers. Data collection: Multiple sources of data including participant-reported health outcomes and experience of care, qualitative interviews, records of the programme were collected at different time points. Results: Reach: Of 394 eligible men at various stages of survivorship, 142 consented (36% consent rate) and 136 (96%) completed the programme. Adoption: All men participated in general care coordination and more than half participated in exercise and/or nutrition management interventions. Participation in the specialised support component (ie, psychosocial and sexual health support, continence management) was low despite the high level of need reported by men. Effectiveness: Overall, the men reported improvements in their experience of care. Implementation: Factors such as addressing service gaps, provision of specialised services, care coordination, adoption of needs-based and telehealth-based approaches were identified as enablers to the successful implementation of the programme. Issues such as insufficient integration with existing services, lack of resources and high caseload of the intervention team, men's reluctance to discuss needs and lack of confidence with technology were barriers in implementing the programme. Conclusion: Survivorship interventions are relevant to men regardless of the stage of their disease and treatments undertaken. It is possible to provide access to a comprehensive model of survivorship
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- 2022
63. Evaluating a multicomponent survivorship programme for men with prostate cancer in Australia: a single cohort study.
- Abstract
OBJECTIVE: To evaluate the implementation of a multicomponent survivorship programme for men with prostate cancer and their carers. DESIGN: A single cohort study, guided by the RE-AIM framework. SETTING: Multiple health services in Australia. PARTICIPANTS: Men with prostate cancer and their carers, and health professionals. INTERVENTION: A 12-month telehealth programme that provided centralised and coordinated decision and information support, exercise and nutrition management, specialised clinical support and practical support to men and their carers. DATA COLLECTION: Multiple sources of data including participant-reported health outcomes and experience of care, qualitative interviews, records of the programme were collected at different time points. RESULTS: Reach: Of 394 eligible men at various stages of survivorship, 142 consented (36% consent rate) and 136 (96%) completed the programme. Adoption: All men participated in general care coordination and more than half participated in exercise and/or nutrition management interventions. Participation in the specialised support component (ie, psychosocial and sexual health support, continence management) was low despite the high level of need reported by men. Effectiveness: Overall, the men reported improvements in their experience of care. Implementation: Factors such as addressing service gaps, provision of specialised services, care coordination, adoption of needs-based and telehealth-based approaches were identified as enablers to the successful implementation of the programme. Issues such as insufficient integration with existing services, lack of resources and high caseload of the intervention team, men's reluctance to discuss needs and lack of confidence with technology were barriers in implementing the programme. CONCLUSION: Survivorship interventions are relevant to men regardless of the stage of their disease and treatments undertaken. It is possible to provide access to a comprehensive model of survivorship
- Published
- 2022
64. Weight loss for overweight and obese patients with prostate cancer: A study protocol of a randomised trial comparing clinic-based versus telehealth delivered exercise and nutrition intervention (the TelEX trial)
- Abstract
Introduction Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer. Methods and analysis A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥ 25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7-12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches. Ethics and dissemination Ethics approval has been obtained from the Edith Cowa
- Published
- 2022
65. Evaluating a multicomponent survivorship programme for men with prostate cancer in Australia: A single cohort study
- Abstract
Objective: To evaluate the implementation of a multicomponent survivorship programme for men with prostate cancer and their carers. Design: A single cohort study, guided by the RE-AIM framework. Setting: Multiple health services in Australia. Participants: Men with prostate cancer and their carers, and health professionals. Intervention: A 12-month telehealth programme that provided centralised and coordinated decision and information support, exercise and nutrition management, specialised clinical support and practical support to men and their carers. Data collection: Multiple sources of data including participant-reported health outcomes and experience of care, qualitative interviews, records of the programme were collected at different time points. Results: Reach: Of 394 eligible men at various stages of survivorship, 142 consented (36% consent rate) and 136 (96%) completed the programme. Adoption: All men participated in general care coordination and more than half participated in exercise and/or nutrition management interventions. Participation in the specialised support component (ie, psychosocial and sexual health support, continence management) was low despite the high level of need reported by men. Effectiveness: Overall, the men reported improvements in their experience of care. Implementation: Factors such as addressing service gaps, provision of specialised services, care coordination, adoption of needs-based and telehealth-based approaches were identified as enablers to the successful implementation of the programme. Issues such as insufficient integration with existing services, lack of resources and high caseload of the intervention team, men's reluctance to discuss needs and lack of confidence with technology were barriers in implementing the programme. Conclusion: Survivorship interventions are relevant to men regardless of the stage of their disease and treatments undertaken. It is possible to provide access to a comprehensive model of survivorship
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- 2022
66. Experiences of 'traditional' and 'one-stop' MRI-based prostate cancer diagnostic pathways in England: a qualitative study with patients and GPs
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Merriel, Samuel William David, Archer, Stephanie, Forster, Alice S, Eldred-Evans, David, McGrath, John, Ahmed, Hashim Uddin, Hamilton, Willie, Walter, Fiona M, Merriel, Samuel William David [0000-0003-2919-9087], Archer, Stephanie [0000-0003-1349-7178], Forster, Alice S [0000-0002-9933-7919], Ahmed, Hashim Uddin [0000-0003-1674-6723], Hamilton, Willie [0000-0003-1611-1373], Walter, Fiona M [0000-0002-7191-6476], Apollo - University of Cambridge Repository, and Walter, Fiona [0000-0002-7191-6476]
- Subjects
Adult ,Aged, 80 and over ,Male ,urological tumours ,Attitude of Health Personnel ,Prostatic Neoplasms ,General Medicine ,Middle Aged ,Prostate-Specific Antigen ,Magnetic Resonance Imaging ,State Medicine ,primary care ,England ,General Practitioners ,Prostatic Neoplasms/diagnostic imaging ,Humans ,Early Detection of Cancer ,Qualitative Research ,prostate disease ,Aged - Abstract
Funder: Wellcome Trust, OBJECTIVES: This study aimed to understand and explore patient and general practitioner (GP) experiences of 'traditional' and 'one-stop' prostate cancer diagnostic pathways in England. DESIGN: Qualitative study using semi-structured interviews, analysed using inductive thematic analysis SETTING: Patients were recruited from National Health Service (NHS) Trusts in London and in Devon; GPs were recruited via National Institute for Health Research (NIHR) Clinical Research Networks. Interviews were conducted in person or via telephone. PARTICIPANTS: Patients who had undergone a MRI scan of the prostate as part of their diagnostic work-up for possible prostate cancer, and GPs who had referred at least one patient for possible prostate cancer in the preceding 12 months. RESULTS: 22 patients (aged 47-80 years) and 10 GPs (6 female, aged 38-58 years) were interviewed. Patients described three key themes: cancer beliefs in relation to patient's attitudes towards prostate cancer;communication with their GP and specialist having a significant impact on experience of the pathway and pathway experience being influenced by appointment and test burden. GP interview themes included: the challenges of dealing with imperfect information in the current pathway; managing uncertainty in identifying patients with possible prostate cancer and sharing this uncertainty with them, and other social, cultural and personal contextual influences. CONCLUSIONS: Patients and GPs reported a range of experiences and views of the current prostate cancer diagnostic pathways in England. Patients valued 'one-stop' pathways integrating prostate MRI and diagnostic consultations with specialists over the more traditional approach of several hospital appointments. GPs remain uncertain how best to identify patients needing referral for urgent prostate cancer testing due to the lack of accurate triage and risk assessment strategies.
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- 2022
67. Delphi study to identify consensus on patient selection for hydrogel rectal spacer use during radiation therapy for prostate cancer in the UK
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Heather Ann Payne, Suneil Jain, Clive Peedell, Albert Edwards, James Andrew Thomas, Prantik Das, Amanda Hansson Hedblom, Emily Woodward, Rhodri Saunders, and Amit Bahl
- Subjects
Organs at Risk ,Male ,Delphi Technique ,Patient Selection ,Rectum ,Prostatic Neoplasms ,toxicity ,Hydrogels ,Radiotherapy Dosage ,radiation oncology ,General Medicine ,United Kingdom ,Prostatic Neoplasms - radiotherapy ,SDG 3 - Good Health and Well-being ,Quality of Life ,Humans ,radiotherapy ,prostate disease - Abstract
ObjectivesTo identify consensus on patient prioritisation for rectal hydrogel spacer use during radiation therapy for the treatment of prostate cancer in the UK.DesignDelphi study consisting of two rounds of online questionnaires, two virtual advisory board meetings and a final online questionnaire.SettingRadical radiation therapy for localised and locally advanced prostate cancer in the UK.ParticipantsSix leading clinical oncologists and one urologist from across the UK.InterventionsRectal hydrogel spacer.Primary and secondary outcome measuresNone reported.ResultsThe panel reached consensus on the importance of minimising toxicity for treatments with curative intent and that even low-grade toxicity-related adverse events can significantly impact quality of life. There was agreement that despite meeting rectal dose constraints, too many patients experience rectal toxicity and that rectal hydrogel spacers in eligible patients significantly reduces toxicity-related adverse events. However, as a consequence of funding limitations, patients need to be prioritised for spacer use. A higher benefit of spacers can be expected in patients on anticoagulation and in patients with diabetes or inflammatory bowel disease, but consensus could not be reached regarding patient groups expected to benefit less. While radiation therapy regimen is not a main factor determining prioritisation, higher benefit is expected in ultrahypofractionated regimens.ConclusionThere is a strong and general agreement that all patients with prostate cancer undergoing radical radiation therapy have the potential to benefit from hydrogel spacers. Currently, not all patients who could potentially benefit can access hydrogel spacers, and access is unequal. Implementation of the consensus recommendations would likely help prioritise and equalise access to rectal spacers for patients in the UK.
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- 2022
68. Clinical Approach to Prostate Disease
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Zani, Danilo, Simeone, Claudio, Cunico, Sergio Cosciani, Grazioli, Luigi, editor, and Olivetti, Lucio, editor
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- 2009
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69. Analysis of lower urinary tract disease of dogs.
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Mendóza-López, Claudia Iveth, Del-Angel-Caraza, Javier, Quijano-Hernández, Israel Alejandro, and Barbosa-Mireles, Marco Antonio
- Abstract
Copyright of Pesquisa Veterinaria Brasileira is the property of Colegio Brasileiro de Patologia Animal - CBPA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2017
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70. The Role of ERα and ERβ in theProstate: Insights from Genetic Models and Isoform-Selective Ligands
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McPherson, S. J., Ellem, S. J., Patchev, V., Fritzemeier, K. H., Risbridger, G. P., Korach, K. S., editor, and Wintermantel, T., editor
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- 2007
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71. Europa Uomo: The European Prostate Cancer Coalition
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Hudson, Tom, Denis, Louis J., Schlag, P. M., editor, Senn, H. -J., editor, Kleihues, P., editor, Stiefel, F., editor, Groner, B., editor, Wallgren, A., editor, Rentchnik, P., editor, Ramon, Jacob, editor, and Denis, Louis J., editor
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- 2007
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72. Reliability and validity of assessment methods available in primary care for bladder outlet obstruction and benign prostatic obstruction in men with lower urinary tract symptoms
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Tom Vredeveld, Esther van Benten, Rikie E P M Beekmans, M Patrick Koops, Johannes C F Ket, Jurgen Mollema, Stephan P J Ramaekers, Jan J M Pool, Michel W Coppieters, and Annelies L Pool-Goudzwaard
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Male ,Urinary Bladder Neck Obstruction ,primary care ,Lower Urinary Tract Symptoms ,Primary Health Care ,Prostatic Hyperplasia ,Humans ,Reproducibility of Results ,epidemiology ,Female ,General Medicine ,urologic and male genital diseases ,prostate disease - Abstract
ObjectivesTo systematically review the literature regarding the reliability and validity of assessment methods available in primary care for bladder outlet obstruction or benign prostatic obstruction in men with lower urinary tract symptoms (LUTS).DesignSystematic review with best evidence synthesis.SettingPrimary care.ParticipantsMen with LUTS due to bladder outlet obstruction or benign prostatic obstruction.Review methodsPubMed, Ebsco/CINAHL and Embase databases were searched for studies on the validity and reliability of assessment methods for bladder outlet obstruction and benign prostatic obstruction in primary care. Methodological quality was assessed with the COSMIN checklist. Studies with poor methodology were excluded from the best evidence synthesis.ResultsOf the 5644 studies identified, 61 were scored with the COSMIN checklist, 37 studies were included in the best evidence synthesis, 18 evaluated bladder outlet obstruction and 17 benign prostatic obstruction, 2 evaluated both. Overall, reliability was poorly evaluated. Transrectal and transabdominal ultrasound showed moderate to good validity to evaluate bladder outlet obstruction. Measured prostate volume with these ultrasound methods, to identify benign prostatic obstruction, showed moderate to good accuracy, supported by a moderate to high level of evidence. Uroflowmetry for bladder outlet obstruction showed poor to moderate diagnostic accuracy, depending on used cut-off values. Questionnaires were supported by high-quality evidence, although correlations and diagnostic accuracy were poor to moderate compared with criterion tests. Other methods were supported by low level evidence.ConclusionClinicians in primary care can incorporate transabdominal and transrectal ultrasound or uroflowmetry in the evaluation of men with LUTS but should not solely rely on these methods as the diagnostic accuracy is insufficient and reliability remains insufficiently researched. Low-to-moderate levels of evidence for most assessment methods were due to methodological shortcomings and inconsistency in the studies. This highlights the need for better study designs in this domain.
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- 2022
73. Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy : study protocol
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Aino Siltari, Jarno Riikonen, Juha Koskimäki, Tomi Pakarainen, Otto Ettala, Peter Boström, Heikki Seikkula, Andres Kotsar, Teuvo Tammela, Mika Helminen, Paavo V Raittinen, Terho Lehtimäki, Mikkel Fode, Peter Østergren, Michael Borre, Antti Rannikko, Timo Marttila, Arto Salonen, Hanna Ronkainen, Sven Löffeler, Teemu J Murtola, Department of Pharmacology, University of Helsinki, Clinicum, Department of Surgery, Urologian yksikkö, HUS Abdominal Center, Tampere University, Clinical Medicine, TAYS Cancer Centre, Health Sciences, Department of Clinical Chemistry, Seinäjoen keskussairaala VA, University of Turku, Jyvaskyla Central Hospital, University of Tartu, Department of Mathematics and Systems Analysis, University of Copenhagen, Aarhus University, Seinäjoki Central Hospital, University of Eastern Finland, University of Oulu, Vestfold Hospital Trust, Aalto-yliopisto, and Aalto University
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Male ,3122 Cancers ,BIOLOGY ,HYPOXIA ,METABOLISM ,3121 Internal medicine ,Atorvastatin ,Humans ,BIOSYNTHESIS ,Randomized Controlled Trials as Topic ,clinical trials ,urological tumours ,CHOLESTEROL ,Prostatic Neoplasms ,Androgen Antagonists ,General Medicine ,ASSOCIATION ,3126 Surgery, anesthesiology, intensive care, radiology ,EFFICACY ,STATIN USE ,SIMVASTATIN ,Clinical Trials, Phase III as Topic ,3121 General medicine, internal medicine and other clinical medicine ,Androgens ,Quality of Life ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Neoplasm Recurrence, Local ,prostate disease - Abstract
IntroductionBlood cholesterol is likely a risk factor for prostate cancer prognosis and use of statins is associated with lowered risk of prostate cancer recurrence and progression. Furthermore, use of statins has been associated with prolonged time before development of castration resistance (CR) during androgen deprivation therapy (ADT) for prostate cancer. However, the efficacy of statins on delaying castration-resistance has not been tested in a randomised placebo-controlled setting.This study aims to test statins’ efficacy compared to placebo in delaying development of CR during ADT treatment for primary metastatic or recurrent prostate cancer. Secondary aim is to explore effect of statin intervention on prostate cancer mortality and lipid metabolism during ADT.Methods and analysisIn this randomised placebo-controlled trial, a total of 400 men with de novo metastatic prostate cancer or recurrent disease after primary treatment and starting ADT will be recruited and randomised 1:1 to use daily 80 mg of atorvastatin or placebo. All researchers, study nurses and patients will be blinded throughout the trial. Patients are followed until disease recurrence or death. Primary outcome is time to formation of CR after initiation of ADT. Serum lipid levels (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and trigyserides) are analysed to test whether changes in serum cholesterol parameters during ADT predict length of treatment response. Furthermore, the trial will compare quality of life, cardiovascular morbidity, changes in blood glucose and circulating cell-free DNA, and urine lipidome during trial.Ethics and disseminationThis study is approved by the Regional ethics committees of the Pirkanmaa Hospital District, Science centre, Tampere, Finland (R18065M) and Tarto University Hospital, Tarto, Estonia (319/T-6). All participants read and sign informed consent form before study entry. After publication of results for the primary endpoints, anonymised summary metadata and statistical code will be made openly available. The data will not include any information that could make it possible to identify a given participant.Trial registration numberClinicaltrial.gov:NCT04026230, Eudra-CT: 2016-004774-17, protocol code: ESTO2, protocol date 10 September 2020 and version 6.
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- 2022
74. Randomised phase II trial of stereotactic body radiotherapy in combination withcheckpoint inhibitors in metastatic castration-resistantprostate cancer (CheckPRO): a study protocol
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Nicklas Juel Spindler, Gitte Fredberg Persson, Susann Theile, Dorte Lisbeth Nielsen, Estrid V Høgdall, Gina Al-Farra, Helle Westergren Hendel, Torben Lorentzen, Inge Marie Svane, Henriette Lindberg, and Rikke Løvendahl Eefsen
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protocols & guidelines ,adult oncology ,General Medicine ,radiotherapy ,prostate disease - Abstract
IntroductionImmunotherapy with checkpoint inhibitors (CPIs) has revolutionised cancer treatment but has no convincing effect in metastatic castration-resistant prostate cancer (mCRPC). It has been suggested that a combination of CPI and hypofractionated stereotactic body radiotherapy (SBRT) may work synergistically, and recent trials have supported this. We hypothesise that adding SBRT to CPI treatment can improve response rates in patients with mCRPC.Methods and analysisThe CheckPRO trial is an open-label, randomised, two-stage, phase II trial. We aim to enrol and randomise 80 evaluable patients with mCRPC who progressed following ≥2 lines of treatment. Enrolment started in November 2019 with 38 months expected enrolment period. The participants receive treatment for 52 weeks including four cycles of ipilimumab and nivolumab with or without concomitant SBRT (24 Gray in three fractions) to a single soft tissue or bone metastasis, followed by 10 cycles of nivolumab. Participants are followed until progression, death, or for 12 months after the end of treatment.Co-primary endpoints are the objective response rate and prostate-specific antigen (PSA) response rate. Secondary endpoints include safety, radiographic progression-free survival, clinical benefit rate, duration of response, PSA-progression-free survival beyond 12 weeks, quality of life and overall survival. Exploratory endpoints include translational analyses of tumour biopsies and consecutive blood samples. Biopsies from metastatic sites are collected at baseline, before the third treatment and at the end of treatment. Blood sampling for immune monitoring and circulating tumour DNA is performed consecutively at baseline and every radiographic assessment.Ethics and disseminationThis study follows the Helsinki Declaration and is approved by the Danish Ethics Committee System (journal no. H-19016100). All participants must receive written and oral information and provide a signed informed consent document prior to inclusion. The study results will be published in an international peer-review journal.Trial registration numberEudraCT number: 2018-003461-34. clinicaltrials.gov IDNCT05655715.
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- 2023
75. 3D Prostate Surface Detection from Ultrasound Images Based on Level Set Method
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Fan, Shao, Voon, Ling Keck, Sing, Ng Wan, Goos, Gerhard, editor, Hartmanis, Juris, editor, van Leeuwen, Jan, editor, Dohi, Takeyoshi, editor, and Kikinis, Ron, editor
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- 2002
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76. CONFIDENT-trial protocol: a pragmatic template for clinical implementation of artificial intelligence assistance in pathology.
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Flach RN, Stathonikos N, Nguyen TQ, Ter Hoeve ND, van Diest PJ, and van Dooijeweert C
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- Male, Humans, Prospective Studies, Retrospective Studies, Algorithms, Artificial Intelligence, Breast Neoplasms diagnosis, Breast Neoplasms pathology
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Introduction: Artificial intelligence (AI) has been on the rise in the field of pathology. Despite promising results in retrospective studies, and several CE-IVD certified algorithms on the market, prospective clinical implementation studies of AI have yet to be performed, to the best of our knowledge. In this trial, we will explore the benefits of an AI-assisted pathology workflow, while maintaining diagnostic safety standards., Methods and Analysis: This is a Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence compliant single-centre, controlled clinical trial, in a fully digital academic pathology laboratory. We will prospectively include prostate cancer patients who undergo prostate needle biopsies (CONFIDENT-P) and breast cancer patients who undergo a sentinel node procedure (CONFIDENT-B) in the University Medical Centre Utrecht. For both the CONFIDENT-B and CONFIDENT-P trials, the specific pathology specimens will be pseudo-randomised to be assessed by a pathologist with or without AI assistance in a pragmatic (bi-)weekly sequential design. In the intervention group, pathologists will assess whole slide images (WSI) of the standard hematoxylin and eosin (H&E)-stained sections assisted by the output of the algorithm. In the control group, pathologists will assess H&E WSI according to the current clinical workflow. If no tumour cells are identified or when the pathologist is in doubt, immunohistochemistry (IHC) staining will be performed. At least 80 patients in the CONFIDENT-P and 180 patients in the CONFIDENT-B trial will need to be enrolled to detect superiority, allocated as 1:1. Primary endpoint for both trials is the number of saved resources of IHC staining procedures for detecting tumour cells, since this will clarify tangible cost savings that will support the business case for AI., Ethics and Dissemination: The ethics committee (MREC NedMec) waived the need of official ethical approval, since participants are not subjected to procedures nor are they required to follow rules. Results of both trials (CONFIDENT-B and CONFIDENT-P) will be published in scientific peer-reviewed journals., Competing Interests: Competing interests: PJvD is a member of the scientific advisory board of Paige and Sectra., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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77. Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications.
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Hu J, Zhu A, Vickers A, Allaf ME, Ehdaie B, Schaeffer A, Pavlovich C, Ross AE, Green DA, Wang G, Ginzburg S, Montgomery JS, George A, Graham JN, Ristau BT, Correa A, Shoag JE, Kowalczyk KJ, Zhang TR, and Schaeffer EM
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- Male, Humans, Prospective Studies, Biopsy adverse effects, Biopsy methods, Rectum pathology, Image-Guided Biopsy adverse effects, Image-Guided Biopsy methods, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Prostate pathology, Prostatic Neoplasms diagnosis, Prostatic Neoplasms pathology
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Introduction: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer., Methods and Analysis: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer., Ethics and Dissemination: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals., Trial Registration Number: NCT04815876., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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78. Efficacy of focal high-dose-rate brachytherapy in the treatment of patients diagnosed with low or favourable: intermediate-risk prostate cancer-a protocol for a randomised controlled trial.
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Jonušas J, Patasius A, Trakymas M, Venius J, Janulionis E, Smailyte G, and Kincius M
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- Male, Humans, Quality of Life, Neoplasm Recurrence, Local etiology, Radiotherapy Dosage, Prostate-Specific Antigen, Randomized Controlled Trials as Topic, Brachytherapy adverse effects, Brachytherapy methods, Prostatic Neoplasms diagnosis
- Abstract
Introduction: Prostate cancer (PCa) is men's second most predominant cancer worldwide. Because the prostate-specific antigen test is used in diagnostics, PCa is more often diagnosed in the early stages, making radical treatment of the disease possible. However, it is estimated that over a million men worldwide suffer from radical treatment-related complications. Thus, focal treatment has been proposed as a solution, which aims to destroy the predominant lesson that determines the progression of the disease. The main objective of our study is to compare the quality of life and efficacy of patients diagnosed with PCa before and after the treatment with focal high-dose-rate brachytherapy and to compare results with focal low-dose-rate brachytherapy and active surveillance., Methods and Analysis: 150 patients diagnosed with low-risk or favourable intermediate-risk PCa who meet the inclusion criteria will be enrolled in the study. Patients are going to be randomly assigned to the study groups: focal high-dose-rate brachytherapy (group 1), focal low-dose-rate brachytherapy (group 2) and active surveillance (group 3). The study's primary outcomes are quality of life after the procedure and time without biochemical disease recurrence. The secondary outcomes are early and late genitourinary and gastrointestinal reactions after the focal high-dose and low-dose-rate brachytherapies and evaluation of the importance and significance of in vivo dosimetry used for high-dose-rate brachytherapy., Ethics and Dissemination: Bioethics committee approval was obtained before this study. The trial results will be published in peer-reviewed journals and at conferences., Trial Registration Number: Vilnius regional bioethics committee; approval ID 2022/6-1438-911., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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79. Strategies used in managing conversations about prostate-specific antigen (PSA) testing among family physicians (FPs): a qualitative study.
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Driedger SM, Kirby S, Maier R, Süss R, Thorlacius L, Saranchuk JW, Bohm E, and Singer A
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- Humans, Male, Physicians, Family, Early Detection of Cancer methods, Mass Screening methods, Prostate-Specific Antigen analysis, Prostatic Neoplasms diagnosis, Prostatic Neoplasms prevention & control
- Abstract
Objectives: Screening for prostate cancer in healthy asymptomatic men using the prostate-specific antigen (PSA) test is controversial due to conflicting recommendations from and a lack of strong evidence regarding the benefit of population-based screening. In Canada and internationally, there is variability in how family physicians (FPs) approach PSA testing in asymptomatic men. The purpose of our study was to explore how family FPs approach discussions with their male patients around PSA testing in Manitoba, Canada., Design: Qualitative descriptive study., Setting and Participants: High-ordering and median-ordering FPs were invited to participate in an interview. In addition to exploring practice behaviours around PSA testing, participants were asked to elaborate on their typical discussion with asymptomatic men who request a PSA test or other tests and procedures that they do not feel are clinically warranted. Data were analysed inductively using a constant-comparison approach., Results: There were important variations between high-ordering and median-ordering FP's approaches to discussing PSA testing. Strategies to facilitate conversations were more frequently identified by median-ordering physicians and often included methods to facilitate assessing their patient's understanding and values. In addition to decision aids, median-ordering FPs used motivational interviewing to tailor a discussion, organised their practice structure and workflow habits in a way that enhanced patient-provider discussions and leveraged 'new' evidence and other aids to guide conversations with men., Conclusion: We found that high-ordering FPs tended to use the PSA test for screening asymptomatic men with limited shared decision-making. Median-ordering FPs used conversational strategies that emphasised uncertainty of benefit and potential risk and did not present the test as a recommendation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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80. Psychological recovery and well-being of spouses of patients with prostate cancer 5 years after primary treatment in Finland: a follow-up survey.
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Lehto US, Aromaa A, and Tammela T
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- Male, Humans, Quality of Life psychology, Follow-Up Studies, Finland, Surveys and Questionnaires, Adaptation, Psychological, Spouses psychology, Prostatic Neoplasms diagnosis
- Abstract
Objective and Setting: To study longitudinally cancer-related experiences of spouses of patients with prostate cancer and the predictors of their psychological recovery and quality of life (QOL) by following the participants of our previous survey at primary cancer treatment in a university hospital., Design: A 5-year longitudinal cohort design., Participants and Procedure: A follow-up questionnaire was mailed to the female spouses/partners who participated in our previous survey (n=104). We quantitatively explored the spouses' prostate cancer-related experiences since the previous survey and measured their current psychological symptom distress and well-being/QOL. Seventy-seven (74%) of the initial participants responded., Outcomes: The main outcome measures were the spouses' psychological recovery (psychological symptoms at the initial survey vs currently) and well-being/QOL (depressive symptoms, domains of QOL) at 5 years. We analysed their predictors with regression analyses., Results: The treatment had been prostatectomy in 70% of the patients. Psychological distress had alleviated in 76% of spouses (p<0.001) and emotional changes decreased (p=0.02), but a deteriorating impact on the partnership (from 4% to 16%) and on sex life ('strong impact' from 23% to 37%) had increased. The outcomes were inversely associated with negative depression-related psychological symptoms and emotional changes either initially or at follow-up. However, some early experiences also predicted the outcomes when other factors were controlled for. Prostate cancer-related information received by the spouses from several sources (leaflets/handouts, TV/radio, internet) predicted better recovery and well-being/QOL, whereas the patients' prostate cancer and treatment-related symptoms (pain, irritability/anger, bowel dysfunction) predicted poorer recovery and well-being/QOL in spouses., Conclusions: A major negative impact of prostate cancer was experienced by the spouses still 5 years after primary treatment. Early prostate cancer-related experiences predicted long-term psychological recovery and QOL. Responding to the early information needs of spouses and effective symptom management for the patients are likely to enhance the spouses' long-term recovery and well-being., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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81. Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol.
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Asif A, Nathan A, Ng A, Khetrapal P, Chan VW, Giganti F, Allen C, Freeman A, Punwani S, Lorgelly P, Clarke CS, Brew-Graves C, Muirhead N, Emberton M, Agarwal R, Takwoingi Y, Deeks JJ, Moore CM, and Kasivisvanathan V
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- Male, Humans, Prospective Studies, Magnetic Resonance Imaging methods, Biopsy, Multicenter Studies as Topic, Multiparametric Magnetic Resonance Imaging methods, Prostatic Neoplasms diagnosis
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Introduction: Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach., Methods: Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision., Ethics and Dissemination: Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial., Trial Registration Number: NCT04571840., Competing Interests: Competing interests: AN is an academic clinical fellow funded by the National Institute for Health and Care Research. PK is an academic clinical fellow funded by the National Institute for Health and Care Research and The Urology Foundation. FG is a recipient of the 2020 Young Investigator Award (20YOUN15) funded by the Prostate Cancer Foundation / CRIS Cancer Foundation. SP is supported by the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. ME receives research support from the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. YT is funded by a UK NIHR Postdoctoral Fellowship and supported by the NIHR Birmingham Biomedical Research Centre. CMM is an NIHR Research Professor, and receives grants from MRC, CRUK, Movember, and Prostate Cancer UK. VK is funded by Prostate Cancer UK and The John Black Charitable Foundation. He receives speaker fees from the European Association of Urology, Singapore Urology Association, The Clinical Comms Group and Got IT consulting SL. All authors declare that there are no conflicts of interest. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, NIHR, or the Department of Health and Social Care., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
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- 2023
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82. Examples
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Verbeke, Geert and Molenberghs, Geert
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- 2000
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83. Prostate-specific membrane antigen positron emission tomography compared to multiparametric MRI for prostate cancer diagnosis: a protocol for a systematic review and meta-analysis
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Yi Zhao, Naomi Morka, Benjamin Scott S Simpson, Alex Freeman, Alex Kirkham, Daniel Kelly, Hayley C Whitaker, Mark Emberton, and Joseph M Norris
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Male ,urological tumours ,Urology ,Prostate ,Prostatic Neoplasms ,General Medicine ,Meta-Analysis as Topic ,Positron-Emission Tomography ,Humans ,Multiparametric Magnetic Resonance Imaging ,prostate disease ,MRI ,Systematic Reviews as Topic - Abstract
IntroductionThe introduction of multiparametric MRI (mpMRI) has improved almost every aspect of the prostate cancer diagnostic pathway. However, the novel imaging technique, prostate-specific membrane antigen positron emission tomography (PSMA PET) may have demonstrable accuracy in detecting and staging prostate cancer. Here, we describe a protocol for a systematic review and meta-analysis comparing mpMRI to PSMA PET for the diagnosis of suspected prostate cancer.Methods and analysisA systematic search of MEDLINE, EMBASE, PubMed and Cochrane databases will be conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed for screening, data extraction, statistical analysis and reporting. Included papers will be full-text articles providing original data, written in English articles and comparing the use of PSMA PET with mpMRI in the diagnosis of prostate cancer. All studies published between July 1977 and March 2021 will be eligible for inclusion. Study bias and quality will be assessed using Quadas-2 score. To ensure the quality of the reporting of studies, this protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 checklist.Ethics and disseminationEthical approval will not be required for this systematic review. Findings will be disseminated through peer-reviewed publications and presentations at both national and international conferences.PROSPERO registration numberCRD42021239296.
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- 2021
84. Vasohibin-1 expression as a biomarker of aggressive nature in ductal adenocarcinoma of the prostate: a retrospective cohort study at two centres in Japan
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Mototsugu Oya, Tokuhiro Kimura, Hiroaki Kobayashi, Takeo Kosaka, Shuji Mikami, Michio Kosugi, Yasufumi Sato, and Hiroshi Hongo
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Urology ,CD34 ,Acinar adenocarcinoma ,Cell Cycle Proteins ,Adenocarcinoma ,Gastroenterology ,Surgical pathology ,Japan ,Prostate ,Internal medicine ,medicine ,Humans ,Stage (cooking) ,Retrospective Studies ,urological tumours ,Prostatectomy ,business.industry ,Cancer ,Endothelial Cells ,Prostatic Neoplasms ,Retrospective cohort study ,General Medicine ,medicine.disease ,digestive system diseases ,medicine.anatomical_structure ,Medicine ,business ,Biomarkers ,surgical pathology ,prostate disease - Abstract
ObjectivesVasohibin-1 (VASH1) is an endogenous angiogenesis regulator expressed in activated vascular endothelial cells. We previously reported that high VASH1 expression is a predictor of progression in acinar adenocarcinoma of the prostate. In this study, we evaluated the characteristics of ductal adenocarcinoma of the prostate by comparing the level of VASH1 expression between ductal and acinar adenocarcinoma specimens.Design and settingA retrospective cohort study at two centres in Japan.ParticipantsAmong the 1495 patients who underwent radical prostatectomy or transurethral resection for the past 15 years, a total of 14 patients diagnosed with ductal adenocarcinoma and 20 patients diagnosed with acinar adenocarcinoma with a Gleason score of 4+4 were included.InterventionsWe immunohistochemically examined the CD34 expression as the microvessel density (MVD) and activated endothelial cells as the VASH1 density (vessels per mm2).Primary and secondary outcome measuresThe primary outcome was the association of MVD and VASH1 density between ductal and acinar adenocarcinoma, and the secondary outcome was their oncological outcomes.ResultsNine patients (64.3%) with ductal adenocarcinoma were diagnosed at an advanced clinical stage, and five patients (35.7%) died from cancer during a median follow-up of 56.0 months. The VASH1 densities (mean±SD) in ductal and acinar adenocarcinoma were 45.1±18.5 vs 16.1±21.0 (pConclusionsDuctal adenocarcinoma was more aggressive and had higher VASH1 expression than acinar adenocarcinoma, although MVD was equivalent. These results indicate that VASH1 expression may serve as a novel biomarker for the aggressive nature of ductal adenocarcinoma.
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- 2021
85. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide: a longitudinal study based on Swedish administrative registers
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Per Johansson, Sophie Langenskiöld, and Paulina Jonéus
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Male ,Matching (statistics) ,protocols & guidelines ,Abiraterone Acetate ,chemistry.chemical_compound ,Statistical Analysis Plan ,Empirical research ,Covariate ,Statistics ,Nitriles ,Phenylthiohydantoin ,Medicine ,Humans ,Longitudinal Studies ,Protocol (science) ,Sweden ,Cancer och onkologi ,urological tumours ,business.industry ,public health ,Abiraterone acetate ,General Medicine ,Exploratory factor analysis ,Prostatic Neoplasms, Castration-Resistant ,Treatment Outcome ,chemistry ,Evidence Based Practice ,Cancer and Oncology ,Propensity score matching ,Benzamides ,epidemiology ,business ,prostate disease - Abstract
IntroductionThis paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer.Method and analysisThe protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing.DiscussionAs in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
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- 2021
86. Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
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Jim Zhong, Sarah Brown, Maria Serra, Pam Shuttleworth, Peter Bownes, Christopher Thompson, Rachel Reed, Kimberley Reeves, Michael Dubec, Damien McHugh, Cynthia Eccles, Robert Chuter, Yat Man Tsang, N Jane Taylor, Catharine West, David Buckley, Andrew Scarsbrook, Ananya Choudhury, Peter Hoskin, and Ann Henry
- Subjects
Male ,Proteomics ,Radiosurgery/adverse effects ,Manchester Cancer Research Centre ,ResearchInstitutes_Networks_Beacons/mcrc ,Brachytherapy ,Prostatic Neoplasms ,Radiotherapy Dosage ,Brachytherapy/adverse effects ,Prostatic Neoplasms/pathology ,General Medicine ,Radiosurgery ,Re-Irradiation ,Magnetic resonance imaging ,Prostate disease ,Humans ,Feasibility Studies ,Prospective Studies ,RADIOTHERAPY - Abstract
IntroductionRadiotherapy is the most common curative treatment for non-metastatic prostate cancer; however, up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy, high-intensity focused ultrasound and cryotherapy. Systematic review shows that high-dose-rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The reirradiation options for previously irradiated prostate cancer (RO-PIP) trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.Methods and analysisThe primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient-reported outcome measures to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer.Ethics and disseminationThis study has been approved by the Yorkshire and The Humber—Bradford Leeds Research Ethics Committee (Reference: 21/YH/0305, IRAS: 297060, January 2022). The results will be presented in national and international conferences, published in peer-reviewed journals and will be communicated to relevant stakeholders. A plain English report will be shared with the study participants, patients’ organisations and media.Trial registration numberISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team).
- Published
- 2022
87. Malignant epistaxis: a case wandering prostate cancer metastasis.
- Author
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Keerty, Dinesh, Eaton, Kevin C, Trejo, Karina, Strosberg, Carolina, and Haynes, Elizabeth J
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- 2022
- Full Text
- View/download PDF
88. Screening for Prostate Cancer: Background
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Fulton, M. and Garraway, Michael, editor
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- 1995
- Full Text
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89. Prognosis and Survival in Prostate Cancer
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Gould, A., Muir, C. S., Sharp, L., and Garraway, Michael, editor
- Published
- 1995
- Full Text
- View/download PDF
90. Uroflowmetry in Epidemiological Studies of Prostate Disease: Some Critical Considerations
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Jensen, K. M.-E. and Garraway, Michael, editor
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- 1995
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- View/download PDF
91. Hormonal Influences on the Prostate Gland
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Habib, F. K. and Garraway, Michael, editor
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- 1995
- Full Text
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92. Use of Health Care Resources in Prostate Disease
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Black, N. A. and Garraway, Michael, editor
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- 1995
- Full Text
- View/download PDF
93. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- Abstract
Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer. Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing. Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
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- 2021
- Full Text
- View/download PDF
94. Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia:Protocol for a single-centre, randomised, double-blind, placebo-controlled trial - The DEXAPAE study
- Abstract
Introduction Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. Methods and analysis In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. Ethics and dissemination Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.
- Published
- 2021
95. High-dose vitamin D supplementation to prevent prostate cancer progression in localised cases with low-to-intermediate risk of progression on active surveillance (ProsD): Protocol of a phase II randomised controlled trial
- Abstract
Introduction: Active surveillance (AS) for patients with prostate cancer (PC) with low risk of PC death is an alternative to radical treatment. A major drawback of AS is the uncertainty whether a patient truly has low risk PC based on biopsy alone. Multiparametric MRI scan together with biopsy, appears useful in separating patients who need curative therapy from those for whom AS may be safe. Two small clinical trials have shown short-term high-dose vitamin D supplementation may prevent PC progression. There is no substantial evidence for its long-term safety and efficacy, hence its use in the care of men with PC on AS needs assessment. This protocol describes the ProsD clinical trial which aims to determine if oral high-dose vitamin D supplementation taken monthly for 2 years can prevent PC progression in cases with low-to-intermediate risk of progression. Method and analysis: This is an Australian national multicentre, 2:1 double-blinded placebo-controlled phase II randomised controlled trial of monthly oral high-dose vitamin D supplementation (50 000 IU cholecalciferol), in men diagnosed with localised PC who have low-to-intermediate risk of disease progression and are being managed by AS. This trial will assess the feasibility, efficacy and safety of supplementing men with an initial oral loading dose of 500 000 IU cholecalciferol, followed by a monthly oral dose of 50 000 IU during the 24 months of AS. The primary trial outcome is the commencement of active therapy for clinical or non-clinical reason, within 2 years of AS. Ethics and dissemination: This trial is approved by Bellberry Ethics Committee (2016-06-459). All results will be reported in peer-reviewed journals. Trial registration number: ACTRN12616001707459.
- Published
- 2021
96. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- Abstract
Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer. Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing. Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
- Published
- 2021
- Full Text
- View/download PDF
97. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- Abstract
Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer. Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing. Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
- Published
- 2021
- Full Text
- View/download PDF
98. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- Abstract
Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer. Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing. Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
- Published
- 2021
- Full Text
- View/download PDF
99. Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia:Protocol for a single-centre, randomised, double-blind, placebo-controlled trial - The DEXAPAE study
- Abstract
Introduction Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. Methods and analysis In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. Ethics and dissemination Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.
- Published
- 2021
100. Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- Abstract
Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer. Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing. Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
- Published
- 2021
- Full Text
- View/download PDF
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