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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.

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.

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.

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.

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).

IntroductionProstate cancer (PCa) is the most common cancer in Canadian men. Current models of survivorship care are no longer adequate to address the chronic and complex survivorship needs of patients today. Virtual care models for cancer survivorship have recently been associated with comparable clinical outcomes and lower costs to traditional follow-up care, with patients favouring off-site and on-demand visits. Building on their viability, our research group conceived the Ned Clinic—a virtual PCa survivorship model that provides patients with access to lab results, collects patient-reported outcomes, alerts clinicians to emerging issues, and promotes patient self-care. Despite the promise of the Ned Clinic, the model remains limited by its dependence on oncology specialists, lack of an autonomous triage algorithm, and has only been implemented among PCa survivors living in Ontario.Methods and analysisOur programme of research comprises two main research objectives: (1) to evaluate the process and cost of implementing and sustaining five nurse-led virtual PCa survivorship clinics in three provinces across Canada and identify barriers and facilitators to implementation success and (2) to assess the impact of these virtual clinics on implementation and effectiveness outcomes of enrolled PCa survivors. The design phase will involve developing an autonomous triage algorithm and redesigning the Ned Clinic towards a nurse-led service model. Site-specific implementation plans will be developed to deploy a localised nurse-led virtual clinic at each centre. Effectiveness will be evaluated using a historical control study comparing the survivorship outcomes of 300 PCa survivors enrolled in the Ned Clinic with 300 PCa survivors receiving traditional follow-up care.Ethics and disseminationAppropriate site-specific ethics approval will be secured prior to each research phase. Knowledge translation efforts will include diffusion, dissemination, and application approaches to ensure that knowledge is translated to both academic and lay audiences.

OBJECTIVE. The purpose of this study was to report on the practice patterns and challenges of performing and interpreting prostate MRI. SUBJECTS AND METHODS. An electronic survey regarding prostate MRI practice patterns and challenges was sent to members of the Society of Abdominal Radiology. RESULTS. The response rate was 15% (212/1446). Most (65%) of the respondents were academic abdominal radiologists with 1–5 (52%), 6–10 (20%), 11–20 (15%), and more than 20 (5%) years of experience in reporting prostate MRI. The numbers of prostate MRI examinations reported per week were 0–5 (43%), 6–10 (38%), 11–20 (12%), 21–30 (5%), and more than 30 (2%). Imaging was performed at 3 T (58%), 1.5 T (20%), or either (21%), and most examinations (83%) were performed without an endorectal coil. Highest b values ranged from 800 to 5000 s/mm(2); 1400 s/mm(2) (26%) and 1500 s/mm(2) (30%) were the most common. Most respondents (79%) acquired dynamic contrast-enhanced images with temporal resolution of less than 10 seconds. Most (71%) of the prostate MRI studies were used for fusion biopsy. PI-RADS version 2 was used by 92% of the respondents and template reporting by 80%. Challenges to performing and interpreting prostate MRI were scored on a 1–5 Likert scale (1, easy; 2, somewhat easy; 3, neutral; 4, somewhat difficult; 5, very difficult). The median scores were 2 or 3 for patient preparatory factors. Image acquisition and reporting factors were scored 1–2, except for performing spectroscopy or using an endorectal coil, both of which scored 4. Acquiring patient history scored 2 and quality factors scored 3. CONCLUSION. Most radiologists perform prostate MRI at 3 T without an endorectal coil and interpret the images using PI-RADS version 2. Challenges include obtaining quality images, acquiring feedback, and variability in the interpretation of PI-RADS scores.

Automated disease classification could significantly improve the accuracy of prostate cancer diagnosis on MRI, which is a difficult task even for trained experts. Convolutional neural networks (CNNs) have shown some promising results for disease classification on multi-parametric MRI. However, CNNs struggle to extract robust global features about the anatomy which may provide important contextual information for further improving classification accuracy. Here, we propose a novel multi-scale hybrid CNN/transformer architecture with the ability of better contextualising local features at different scales. In our application, we found this to significantly improve performance compared to using CNNs. Classification accuracy is even further improved with a stacked ensemble yielding promising results for binary classification of prostate lesions into clinically significant or non-significant.

IntroductionMultiparametric magnetic resonance imaging (mpMRI) has improved the triage of men with suspected prostate cancer, through precision prebiopsy identification of clinically significant disease. While multiple important characteristics, including tumour grade and size have been shown to affect conspicuity on mpMRI, tumour location and association with mpMRI visibility is an underexplored facet of this field. Therefore, the objective of this systematic review and meta-analysis is to collate the extant evidence comparing MRI performance between different locations within the prostate in men with existing or suspected prostate cancer. This review will help clarify mechanisms that underpin whether a tumour is visible, and the prognostic implications of our findings.Methods and analysisThe databases MEDLINE, PubMed, Embase and Cochrane will be systematically searched for relevant studies. Eligible studies will be full-text English-language articles that examine the effect of zonal location on mpMRI conspicuity. Two reviewers will perform study selection, data extraction and quality assessment. A third reviewer will be involved if consensus is not achieved. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will inform the methodology and reporting of the review. Study bias will be assessed using a modified Newcastle-Ottawa scale. A thematic approach will be used to synthesise key location-based factors associated with mpMRI conspicuity. A meta-analysis will be conducted to form a pooled value of the sensitivity and specificity of mpMRI at different tumour locations.Ethics and disseminationEthical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42021228087.

ObjectivesActive surveillance (AS) enables men with low risk, localised prostate cancer (PCa) to avoid radical treatment unless progression occurs; lack of reliable AS protocols to determine progression leaves uncertainties for men and clinicians. This study investigated men’s strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.DesignLongitudinal serial in-depth qualitative interviews every 2–3 years for a median 7 (range 6–14) years following diagnosis.SettingFour centres within the UK Protect trial.ParticipantsPurposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52–68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM. Eleven men continued with AM throughout the study period (median 7 years). Nine received radical treatment after a median 4 years (range 0.8–13.8 years).InterventionAM: 3-monthly serum prostate-specific antigen (PSA)-level assessment (year 1), 6–12 monthly thereafter; increase in PSA ≥50% during previous 12 months or patient/clinician concern triggered review.Main outcomesThematic analysis of 73 interviews identified strategies to accommodate uncertainty and anxiety of living with untreated cancer; implications for patient care.ResultsMen sought clarity, control or reassurance, with contextual factors mediating individual responses. Trust in the clinical team was critical for men in balancing anxiety and facilitating successful management change/continued monitoring. Only men from ProtecT were included; men outside ProtecT may have different experiences.ConclusionMen looked to clinicians for clarity, control and reassurance. Where provided, men felt comfortable continuing AM or having radical treatments when indicated. Clinicians build patient trust by clearly describing uncertainties, allowing patients control wherever possible and being aware of how context influences individual responses. Insights indicate need for supportive services to build trust and patient engagement over the long term.Trial registration numberISRCTN20141297; Pre-results.

Introduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use of PSA as a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informed men with an adequate health status and a life-expectancy of at least 10 years or to men at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health. Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methods and analysis: A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewing medical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from 2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded. Discussion: The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused. Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.

IntroductionSystemic therapy with androgen deprivation therapy (ADT) and intensification with agents such as docetaxel, abiraterone acetate and enzalutamide has resulted in improved overall survival in men with de novo synchronous metastatic hormone-sensitive prostate cancer (mHSPC). Novel local cytoreductive treatments and metastasis-directed therapy are now being evaluated. Such interventions may provide added survival benefit or delay the requirement for further systemic agents and associated toxicity but can confer additional harm. Understanding men’s preferences for treatment options in this disease state is crucial for patients, clinicians, carers and future healthcare service providers.MethodsUsing a prospective, multicentre discrete choice experiment (DCE), we aim to determine the attributes associated with treatment that are most important to men with mHSPC. Furthermore, we plan to determine men’s preferences for, and trade-offs between, the attributes (survival and side effects) of different treatment options including systemic therapy, local cytoreductive approaches (external beam radiotherapy, cytoreductive radical prostatectomy or minimally invasive ablative therapy) and metastases-directed therapies (metastasectomy or stereotactic ablative body radiotherapy). All men with newly diagnosed mHSPC within 4 months of commencing ADT and WHO performance status 0–2 are eligible. Men who have previously consented to a cytoreductive treatment or have developed castrate-resistant disease will be excluded. This study includes a qualitative analysis component, with patients (n=15) and healthcare professionals (n=5), to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation in a DCE. The main phase component planned recruitment is 300 patients over 1 year, commencing in January 2021, with planned study completion in March 2022.Ethics and disseminationEthical approval was obtained from the Health Research Authority East of England, Cambridgeshire and Hertfordshire Research Ethics Committee (Reference: 20/EE/0194). Project information will be reported on the publicly available Imperial College London website and the Heath Economics Research Unit (HERU website including the HERU Blog). We will use the social media accounts of IP5-MATTER, Imperial Prostate London, HERU and the individual researchers to disseminate key findings following publication. Findings from the study will be presented at national/international conferences and peer-reviewed journals. Authorship policy will follow the recommendations of the International Committee of Medical Journal Editors.Trial registration numberNCT04590976.

Lower urinary tract diseases (LUTD) include different conditions that affect the urinary bladder, urethra and prostate. The objective of this study was to determine the frequency of different related diseases, to characterize the population affected, and to determine risk factors in dogs. The clinical cases were diagnosed with LUTD through physical examination, and clinical laboratory and imaging studies. Male dogs had a greater predisposition to present a LUTD. Dogs from 3 months to 18 years with a median of 8 years were affected, and the most affected breeds were Poodle, Labrador, German shepherd, Schnauzer, Cocker Spaniel and Chihuahua. The LUTD presented with the following frequencies: bacterial urinary tract infection 34.02%; micturition disorders 22.68%; urolithiasis 20.61%; prostatic disease 14.43%; traumatic problems 8.24%. Sixty-seven per cent of the cases were specific diseases, such as uncomplicated and complicated bacterial urinary tract infections, urinary retention of neurologic origin and silica urolithiasis. RESUMO: Doenças do trato urinário inferior (DTUI) incluem várias condições clínicas que afetam a bexiga, próstata e uretra. O objetivo deste estudo foi determinar a frequência de diferentes doenças relacionadas, caracterizar a população afetada, e determinar os fatores de risco em cães. Os casos clínicos com DTUI foram diagnosticados através de exame físico, estudos laboratoriais e de imagem. Os cães machos apresentam uma maior predisposição para DTUI. Foram afectados cães com idades compreendidas entre os 3 meses a 18 anos, com uma mediana de oito anos, sendo as raças mais predispostas os Poodle, Labrador, Pastor Alemão, Schnauzer, Cocker Spaniel e Chihuahua. A etiologia DTUI apresentou as seguintes frequências: 34,02% foram originadas em infecção do trato urinário inferior; 22,68% em distúrbios miccionais; 20,61% em urolitíase; 14,43% em doença prostática; 8,24% em problemas traumáticos. Sessenta e sete por cento dos casos de DTUI estavam associados a doenças específicas, tais como infecções bacterianas do trato urinário não complicadas e complicadas, retenção urinária neurogénica e urolitíase por sílica.

IntroductionThe primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI.Methods and analysisThe ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50–75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer.Ethics and disseminationReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London–Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK.Trial registration numberClinicalTrials.gov Registry (NCT04063566).

IntroductionLimited data from controlled clinical trials are available for men who experience biochemical recurrence after definitive therapy for prostate cancer. In the absence of overt metastases, patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) often receive androgen deprivation therapy (ADT). There is no standard-of-care consensus on optimal ADT timing, although most men are treated prior to metastases, especially those with high-risk features (Gleason score 8–10 or prostate-specific antigen doubling time (PSADT) Methods and analysisEMBARK is a randomised, phase 3 study of high-risk patients with nmCSPC, a PSADT of ≤9 months and a screening PSA of ≥2 ng/mL above the nadir after radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) with or without postoperative RT. Men (n=1050) are randomised 1:1:1 to enzalutamide 160 mg/day plus LHRHa or placebo plus LHRHa (double-blind arms) or enzalutamide monotherapy (open-label arm). Treatment is suspended at week 37 if PSA concentrations are Ethics and disseminationThe study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.Trial registration numberNCT02319837.

Objective: To investigate the knowledge and prevalence of use of saw palmetto and other herbal products among men attending the urology outpatient clinic at San Fernando General Hospital. Subjects and methods: This was a prospective, cross-sectional study carried out between February and May 2015. A structured, interviewer administered questionnaire was used to collect data from randomly selected men with prostate cancer or benign prostatic hyperplasia (BPH) and who were part of our outpatient clinics. This questionnaire contained sections on sociodemographic details as well as knowledge and attitudes towards herbal supplements with emphasis on saw palmetto. Data were compiled in Microsoft Excel and analysed using SPSS version 20. Results: Two hundred (200) men were interviewed. The mean age of the population was 69 years (Std. Dev. = 8.06) and most were from the south (56.5%) or central (19%) regions of Trinidad. 52% had BPH and 34.5% had prostate cancer. Overall, 85 men (42.5%) indicated use of herbal supplements of whom 53 (62.3%) used saw palmetto either alone or in combination with other products. Among men who had heard of saw palmetto or used it, 25% believed it may be used to reduce the risk of or treat prostate cancer. Thirty-six percent (36%) were of the opinion that saw palmetto is effective in treating the symptoms of an enlarged prostate. Conclusion: This study demonstrates that the use of herbal products is common among men with prostate disease in Trinidad and Tobago and that saw palmetto is the most common product used. It also highlights the prevalence of unsubstantiated beliefs as well as the uncertainty about the efficacy of saw palmetto. African Journal of Urology (2017) 23, 249–252

IntroductionProstate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and overdiagnosis of low-risk cancers. The STHLM3 trial has paved way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer. Targeted prostate biopsies based on MRI images have shown non-inferior sensitivity to detect significant prostate cancer and decrease the number of biopsies and non-significant cancers among men referred for prostate biopsy in clinical practice. The strategy of the STHLM3-MRI project is to study an improved diagnostic pathway including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies.MethodsThis study compares prostate cancer detection using prostate-specific antigen (PSA) and systematic biopsies to the improved pathway for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context. The study will recruit 10 000 participants during 1 June 2018 to 1 June 2020 combining a paired and randomised design. Participants are grouped by PSA and Stockholm3 test level. Men with Stockholm3 ≥11% or PSA ≥3 ng/mL are randomised to systematic or MRI-targeted biopsies. This protocol follows SPIRIT guidelines. Endpoints include the number of detected prostate cancers, number of performed biopsy procedures and number of performed MRIs. Additional aims include to assess the health economic consequences and development of automated image-analysis.Ethics and disseminationThe study is approved by the regional ethical review board in Stockholm (2017-1280/31). The study findings will be published in peer-review journals. Findings will also be disseminated by conference/departmental presentations and by media.Trial registration numberNCT03377881; Pre-results.

INTRODUCTION AND OBJECTIVES:Ejaculation frequency, including sexual intercourse, nocturnal emissions, and masturbation, affect the development of prostate disease, such as benign prostatic hyperpla...

Introduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use ofPSAas a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informedmen with an adequate health status and a life-expectancy of at least 10 years or tomen at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health. Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methods and analysis: A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewingmedical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded. Discussion: The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused. Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.

BackgroundThe diagnosis of lower urinary tract symptoms related to suspected bladder outflow obstruction from benign prostate hyperplasia/enlargement in men is increasing. This is leading to high demand on healthcare services; however, there is limited knowledge of differences in pharmacotherapy prescribing for this condition based on geography.ObjectiveTo investigate potential variation in drug prescribing for suspected bladder outflow obstruction in Scotland, based on analysis of publicly available data, to identify trends and inform future prescribing.Study designA longitudinal register-based data study of prescribing and patient data publicly available from Scottish registries. All information is available as monthly aggregates at the level of single general practices.Setting and participants903 (97%) general practices in Scotland, over a 50-month period (October 2015 to November 2019).Outcome measurements and statistical analysisWe analysed numbers of daily doses of drugs for suspected bladder outflow obstruction prescribed per month using a Bayesian Poisson regression analysis, incorporating random effects to account for spatial and temporal elements.ResultsPrescriptions for suspected bladder outflow obstruction medications increased during the observation period (overall average rate of change 1.24±0.28, ranging from 0.893 in Orkney to 1.95 in Lanarkshire). While some determinants of health inequality regarding prescribing practices across health boards are consistent with those known from the literature, other inequalities remain unexplained after accounting for practice-specific and patient-specific characteristics such as deprivation and rurality.ConclusionsInequalities in prescribing for suspected bladder outflow obstruction medications exist in Scotland, partially ascribable to accepted sociodemographic and geographic factors.

ObjectivesTo conduct a systematic review with meta-analysis of cohort studies to evaluate the association of coffee consumption with the risk of prostate cancer.Data sourcesPubMed, Web of Science and Embase were searched for eligible studies up to September 2020.Study selectionCohort studies were included.Data extraction and synthesisTwo researchers independently reviewed the studies and extracted the data. Data synthesis was performed via systematic review and meta-analysis of eligible cohort studies. Meta-analysis was performed with the “metan” and “glst” commands in Stata 14.0.Main outcomes and measuresProstate cancer was the main outcome. It was classified as localised prostate cancer which included localised or non-aggressive cancers; advanced prostate cancer which included advanced or aggressive cancers; or fatal prostate cancer which included fatal/lethal cancers or prostate cancer-specific deaths.ResultsSixteen prospective cohort studies were finally included, with 57 732 cases of prostate cancer and 1 081 586 total cohort members. Higher coffee consumption was significantly associated with a lower risk of prostate cancer. Compared with the lowest category of coffee consumption, the pooled relative risk (RR) was 0.91 (95% CI 0.84 to 0.98), I2= 53.2%) for the highest category of coffee consumption. There was a significant linear trend for the association (p=0.006 for linear trend), with a pooled RR of 0.988 (95% CI 0.981 to 0.995) for each increment of one cup of coffee per day. For localised, advanced and fatal prostate cancer, the pooled RRs were 0.93 (95% CI 0.87 to 0.99), 0.88 (95% CI 0.71 to 1.09) and 0.84 (95% CI 0.66 to 1.08), respectively. No evidence of publication bias was indicated in this meta-analysis.ConclusionsThis study suggests that a higher intake of coffee may be associated with a lower risk of prostate cancer.

IntroductionFocal therapy has emerged as a promising treatment option for men with localised prostate cancer. However, most of the evaluation of postoperative function has taken place at a relatively high, non-granular level. Most of the data we use to provide informed consent for our patients is obtained from retrospective series, or derived from prospective studies whose primary outcome was oncological. Finally, most studies have focused on erectile function and overlooked other, presumably important, elements of male sexual function. The present study aims at studying in-depth the sexual consequences of focal therapy with various energy sources.Methods and analysisThis will be a mixed-methods research study based on a retrospective and prospective cohort, recruited in parallel. The retrospective cohort will consist of patients treated with focal irreversible electroporation, and the prospective cohort of patients treated with three focal therapy energies. Participants will be recruited from two UK urology centres, one National Health Service and one private. On consent, patients will fill in self-administered validated questionnaires (International Index of Erectile Function-15 (IIEF-15), Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF)) and semistructured interviews will be organised to collect patients’ expectations and postoperative changes in domains such as erection, ejaculation, orgasm, libido/sexual desire, masculinity/virility, penile morphology, pain or discomfort, regret, shame, cancer-related stress, overall impact and partner satisfaction. An exploratory thematic analysis will be performed to detail recurring themes that will be grouped into clusters of experiences. We will then be able to find clusters of agreement and disagreement that will be illustrated using exemplar patient quotations.Ethics and disseminationEthical approval was obtained (Regional Ethics Committee reference 20/NW/0335), as well as Health Research Authority approval. Results will be published in open-access peer-reviewed journals. Findings will also be translated into patient information resources (leaflets, online information sheets).Trial registration numberISRCTN11634296; Pre-results.

IntroductionMultiparametric MRI (mpMRI) has improved risk stratification for men with suspected prostate cancer. Indeed, mpMRI-visible tumours tend to be larger and of higher pathological grade than mpMRI-invisible tumours; however, concern remains around significant cancer that is undetected by mpMRI. There has been considerable recent interest to investigate whether tumour conspicuity on mpMRI is associated with additional histopathological features (including cellular density, microvessel density and unusual prostate cancer subtypes), which may have important clinical implications in both diagnosis and prognosis. Furthermore, analysis of these features may help reveal the radiobiology that underpins the actual mechanisms of mpMRI visibility (and invisibility) of prostate tumours. Here, we describe a protocol for a systematic review of the histopathological basis of prostate cancer conspicuity on mpMRI.Methods and analysisA systematic search of the MEDLINE, PubMed, Embase and Cochrane databases will be conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines will be used to guide screening, thematic reporting and conclusions drawn from all eligible studies. Included papers will be full-text, English-language articles, comparing the histopathological characteristics of mpMRI-visible lesions and mpMRI-invisible tumours. All studies published between January 1950 and January 2020 will be eligible for inclusion. Studies using confirmatory immunohistochemistry for the identification of immune subsets or structural components will be included. Study bias and quality will be assessed using a modified Newcastle-Ottawa scale. To ensure methodological rigour, this protocol is written in accordance with the PRISMA Protocol 2015 checklist. If appropriate, a meta-analysis will be conducted comparing histopathological feature frequency between mpMRI-visible and mpMRI-invisible disease.Ethics and disseminationNo ethical approval will be required as this is an academic review of published literature. Findings will be disseminated through publications in peer-reviewed journals and presentations at national and international conferences.PROSPERO registration numberCRD42020176049

A method is proposed for constructing functional models and their structural representation for the main stages of the automatic analysis of prostate gland ultrasound scan (USS) and transrectal ultrasound scan (TrUSS) data with the aim of increasing the quality and speed of diagnosis, prognostication, and treatment of prostate disease.

Background and Objective: Prostate specific antigen (PSA) is considered as one of the most reliable biomarkers of cancer and other known prostate diseases. In the present study, solid phase sandwich immunoradiometric assay was used to measure the amount of PSA. In this type of measurement, a pair of anti-PSA antibodies on the solid phase and labeled with Iodine-125, participate in forming a complex with two different epitopes of PSA. Methods: Variables such as irradiation level, modification of polymer surfaces by alcohol washing, different concentrations and volumes of antibody, incubation temperature and drying conditions that influence the direct coating process were optimized. Finally, the stability, accuracy and precision of the laboratory kit were evaluated by comparison with a foreign kit. Results: According to the obtained results, preliminary preparations such as irradiation, tube washing and specific temperature conditions are not required during the coating process. Drying by lyophilization method does not affect the quality of coating. Antibody concentration of 2.5 μg/ml and coating volume of 800 μl were determined as the optimum conditions for coating, which had good stability within a year. Alignment of results obtained from the domestic and foreign kits for accuracy of 30 samples from patients was confirmed by T-test (sig 2-tailed= 0.993 and 95% confidence interval). The short-term and long-term precision for three control ranges (low, medium, high) were less than 0.25 and 0.33 of allowable total error (TEa = 10%), respectively. Conclusion: The produced domestic kit has acceptable precision according to the CLIA criteria. Keywords: Biological testing, Radioimmunometric assay, monoclonal antibody, prostate specific antigen, prostate disease.

ObjectiveTo identify risk prediction models for prostate cancer (PCa) that can be used in the primary care and community health settings.DesignSystematic review.Data sourcesMEDLINE and Embase databases combined from inception and up to the end of January 2019.EligibilityStudies were included based on satisfying all the following criteria: (i) presenting an evaluation of PCa risk at initial biopsy in patients with no history of PCa, (ii) studies not incorporating an invasive clinical assessment or expensive biomarker/genetic tests, (iii) inclusion of at least two variables with prostate-specific antigen (PSA) being one of them, and (iv) studies reporting a measure of predictive performance. The quality of the studies and risk of bias was assessed by using the Prediction model Risk Of Bias ASsessment Tool (PROBAST).Data extraction and synthesisRelevant information extracted for each model included: the year of publication, source of data, type of model, number of patients, country, age, PSA range, mean/median PSA, other variables included in the model, number of biopsy cores to assess outcomes, study endpoint(s), cancer detection, model validation and model performance.ResultsAn initial search yielded 109 potential studies, of which five met the set criteria. Four studies were cohort-based and one was a case-control study. PCa detection rate was between 20.6% and 55.8%. Area under the curve (AUC) was reported in four studies and ranged from 0.65 to 0.75. All models showed significant improvement in predicting PCa compared with being based on PSA alone. The difference in AUC between extended models and PSA alone was between 0.06 and 0.21.ConclusionOnly a few PCa risk prediction models have the potential to be readily used in the primary healthcare or community health setting. Further studies are needed to investigate other potential variables that could be integrated into models to improve their clinical utility for PCa testing in a community setting.

IntroductionMinimally invasive surgery in urology has grown considerably in application since its initial description in the early 1990s. Herein, we present the protocol for a systematic review and meta-analysis comparing open versus robotic urological oncological surgery for various clinically relevant outcomes, as well as to assess their comparative penetrance over the past 20 years (2000–2020).Methods and analysisWe will document the penetrance of robotic versus open surgery in the urological oncological field using a national database.Second, we will perform a systematic review and meta-analysis of all published full-text English and non-English language articles from Pubmed, Scopus and Web of Science search engines on surgical treatment of localised prostate, bladder, kidney and testis cancer published between 1st January 2000 to 10th January 2020. We will focus on the highest-volume urological oncological surgeries, namely, radical prostatectomy, radical cystectomy, partial nephrectomy, radical nephrectomy and retroperitoneal lymph node dissection. Study inclusion criteria will comprise clinical trials and prospective and retrospective studies (cohort or case–control series) comparing robotic versus open surgery. Exclusion criteria will comprise meta-analyses, multiple papers with overalapping study-periods, studies analysing national databases and case series describing only one approach (robotic or open). Risk of bias for included studies will be assessed by the appropriate Cochrane risk of bias tool. Principal outcomes assessed will include perioperative, functional, oncological survival and financial outcomes of open versus robotic uro-oncological surgery. Sensitivity analyses will be performed to correlate outcomes of interest with key baseline characteristics and surrogates of surgical expertise.Ethics and disseminationThis comprehensive systematic review and meta-analysis will provide rigorous, consolidated information on contemporary outcomes and trends of open versus robotic urological oncological surgery based on all the available literature. These aggregate data will help physicians better advise patients seeking surgical care for urological cancers.PROSPERO registration numberCRD42017064958.

IntroductionProstate cancer is the most common male cancer with one in four developing non-curable metastatic disease. Initial treatment responses to hormonal therapies are transient and further management options lie between (1) further hormone therapy or (2) a non-hormonal approach involving additional chemotherapy or molecular radiotherapy (radium-223). There is no clear rationale for choosing between these mechanistically different treatment approaches. The biology of hormone resistance is driven through abnormal androgen receptor activity and we can assay this through a blood test measuring androgen receptor variant 7 (AR-V7) expression in circulating tumour cells. Despite increasing evidence supporting AR-V7’s role as a prognostic marker, the clinical utility of such measures remains unknown in helping personalise treatment decisions.Methods and designThe VARIANT feasibility trial is a pragmatic design, to be run over 18 months with participants randomised into the intervention arm receiving biomarker (AR-V7) guided clinical treatment and participants randomised into the control arm with conventional standard management (no biomarker guidance). AR-V7 positive participants (likely to be insensitive to further hormone treatment) will receive chemotherapy or in other cases radium-223 (where routinely available). Seventy male ≥18 years old participants with metastatic castrate resistant prostate cancer clinically indicated to proceed to further hormone therapy or chemotherapy, will be recruited from three National Health Service Trusts based in England, Scotland and Wales. The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.Ethics and disseminationFormal ethics review was undertaken with a favourable opinion, through Wales NRES Committee 2 18/WA/0419. Findings to be disseminated through patient and professional organisations that have expressed their support, media outlets and peer-reviewed journal publication.Trial registration numberNCT10246848

Introduction Radical prostatectomy is the mainstay of treatment for prostate cancer. The vesicourethral anastomosis is a critical step, which most likely impacts urinary continence and urethral stenosis. To date, it still remains unclear whether interrupted and continuous suturing for the anastomosis have different outcomes. Therefore, the aim of this systematic review and meta-analysis is to compare different suture techniques for vesicourethral anastomosis in terms of surgical and functional parameters. Methods and analysis A comprehensive literature search will be conducted covering MEDLINE, Embase, Web of Science, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov. Studies comparing interrupted versus continuous suturing will be included in the analyses. No language restrictions will be applied. Screening, data extraction, statistical analysis and reporting will be done in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Quality assessment will be performed with the help of the Cochrane Collaboration’s tool for assessing risk of bias and the Newcastle-Ottawa Scale for assessing quality of non-randomised studies. The quality of evidence will be evaluated with the Grading of Recommendations Assessment, Development and Evaluation. The primary outcome will be the time until removal of the urinary catheter. Secondary outcomes include rate of extravasation, length of hospital stay, time needed to perform the anastomosis, continence level at defined postoperative intervals and development of urethral strictures. Quantitative analysis will be calculated if meaningful. Ethics and dissemination In order to meet the highest ethical and methodological standards. we followed the PRISMA Protocol 2015 checklist. Each item was answered appropriately. For systematic reviews the ethical issues are strictly methodological as only data that were published earlier will be used. The full manuscript will be submitted to a peer-reviewed journal. Furthermore, the results will be presented on national and international congresses. Trial registration number International prospective register of systematic reviews PROSPERO CRD42017076126.

PurposeGlobally, prostate cancer treatment and outcomes for men vary according to where they live, their race and the care they receive. The TrueNTH Global Registry project was established as an international registry monitoring care provided to men with localised prostate cancer (CaP).ParticipantsSites with existing CaP databases in Movember fundraising countries were invited to participate in the international registry. In total, 25 Local Data Centres (LDCs) representing 113 participating sites across 13 countries have nominated to contribute to the project. It will collect a dataset based on the International Consortium for Health Outcome Measures (ICHOM) standardised dataset for localised CaP.Findings to dateA governance strategy has been developed to oversee registry operation, including transmission of reversibly anonymised data. LDCs are represented on the Project Steering Committee, reporting to an Executive Committee. A Project Coordination Centre and Data Coordination Centre (DCC) have been established. A project was undertaken to compare existing datasets, understand capacity at project commencement (baseline) to collect the ICHOM dataset and assist in determining the final data dictionary. 21/25 LDCs provided data dictionaries for review. Some ICHOM data fields were well collected (diagnosis, treatment start dates) and others poorly collected (complications, comorbidities). 17/94 (18%) ICHOM data fields were relegated to non-mandatory fields due to poor capture by most existing registries. Participating sites will transmit data through a web interface biannually to the DCC.Future plansRecruitment to the TrueNTH Global Registry-PCOR project will commence in late 2017 with sites progressively contributing reversibly anonymised data following ethical review in local regions. Researchers will have capacity to source deidentified data after the establishment phase. Quality indicators are to be established through a modified Delphi approach in later 2017, and it is anticipated that reports on performance against quality indicators will be provided to LDCs.

Introduction The classical pathway for the diagnosis of prostate cancer is transrectal ultrasound-guided (TRUS) biopsy of the prostate initiated on the basis of a raised prostate-specific antigen (PSA). An alternative pathway is to perform multi-parametricMRI (MPMRI) to localise cancer and to use this information to influence the decision for, and conduct of, a subsequent biopsy, known as an MPMRI-targeted biopsy. An MPMRI pathway has been shown to detect a similar or greater amount of clinically significant cancer as TRUS biopsy but has several advantages, including the potential to biopsy fewer men with fewer cores. Methods This is a pragmatic, international, multicentre, parallel group randomised study in which men are allocated in a 1:1 ratio to an MPMRI or TRUS biopsy pathway. This study will assess whether an MPMRI-targeted biopsy approach is non-inferior to a standard TRUS biopsy approach in the diagnosis of clinically significant cancer. Men in the MRI arm will undergo targeted biopsy of suspicious areas only and no biopsy will be carried out if the MRI is non-suspicious. Men in the TRUS biopsy will undergo a standard 10–12-core TRUS biopsy. The main inclusion criteria are a serum PSA ≤20 ng/mL, a digital rectal examination finding of T2 or less and no prior prostate biopsy. The primary outcome is the proportion of men with clinically significant cancer detected. A sample size of at least 470 patients is required. Key secondary outcomes include the proportion of clinically insignificant cancer detected. Ethics and dissemination Ethical approval was obtained from the National Research Ethics Committee East Midlands, Leicester (15/EM/0188). Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. Registration details NCT02380027; Pre-results

Background: Prostate-specific antigen (PSA) screening for prostate cancer results in a large number of unnecessary prostate biopsies. There is a need for specific molecular markers that can be used in combination with PSA to improve the specificity of PSA screening. We examined GADD45a methylation in blood DNA as a molecular marker for prostate cancer diagnosis. Methods: The study included 82 men, with PSA levels >4 ng ml−1 and/or abnormal digital rectal exam, who underwent prostate biopsy. We compared GADD45a methylation in DNA from serum and buffy coat in 44 patients (22 prostate cancer and 22 benign). GADD45a methylation in serum DNA was examined in 82 patients (34 cancer and 48 benign). Results: There was no significant difference in buffy coat GADD45a methylation between cancer and benign patients. Serum GADD45a methylation was significantly higher in cancer than in benign patients. Classification and regression tree predictive model for prostate cancer including risk groups defined by PSA, free circulating DNA (fcDNA) level and GADD45a methylation yielded specificity of 87.5%, sensitivity of 94.1% and receiver operator characteristic curve area of 0.937. Conclusions: Serum GADD45a methylation in combination with PSA and fcDNA level was useful in distinguishing benign from prostate cancer patients.

Aim To evaluate the utilization of functional imaging tests in multiparametric (mp)-MRI of the prostate in routine practice and to assess whether education improves usage. Materials and methods With research ethics board approval, 254 patients underwent mp-MRI [diffusion-weighted imaging (DWI) and dynamic contrast enhancement (DCE)] over a 1-year period at a single tertiary-care referral centre for prostate disease. All studies were reported by fellowship-trained abdominal radiologists. To determine to what extent parametric tests were used, radiology reports were searched for terms indicating usage of DWI/DCE and studies were reviewed to determine whether post-processing of DCE was performed. Midway through the study, an internal continuing medical education (CME) programme was instituted (consisting of lectures, electronic reading material, intra- and inter-departmental prostate rounds) and a standardized reporting template was introduced. Utilization of functional imaging was compared between radiologists by years of experience and by number of examinations interpreted, by study indication, and before and after CME. Results Overall, both DWI and DCE were used in 50.7% of examinations. DWI (67.3%) was more frequently used than DCE (56.3%). DCE contrast curves were generated in 33.5% of studies, and quantitative analysis was performed in only one patient. Use of parametric tests was higher after CME (60.6% versus 40.4%), p = 0.009. There was no correlation between the use of parametric tests and years of experience, ( p = 0.94), and there was no association with the number of examinations interpreted ( p = 0.19–0.97). There was no association between the use of parametric tests and study indication, ( p = 0.16); however, contrast curves were produced more frequently in non-staging studies, ( p = 0.027). Conclusion Parametric tests were underutilized in routine practice. DWI was used more commonly than DCE. CME was associated with increased utilization of mp-MRI.

In the last decade, ample evidence has demonstrated the growing importance of androgen receptor (AR) CAG repeat polymorphism in andrology. This genetic parameter is able to condition the peripheral effects of testosterone and therefore to influence male sexual function and fertility, cardiovascular risk, body composition, bone metabolism, the risk of prostate and testicular cancer, the psychiatric status, and the onset of neurodegenerative disorders. In this review, we extensively discuss the literature data and identify a role for AR CAG repeat polymorphism in conditioning the systemic testosterone effects. In particular, our main purpose was to provide an updated text able to shed light on the many and often contradictory findings reporting an influence of CAG repeat polymorphism on the targets of testosterone action.

Introduction Prostate cancer survivors (PCS) receiving androgen deprivation therapy (ADT) experience deleterious side effects such as unfavourable changes in cardiometabolic factors that lead to sarcopenic obesity and metabolic syndrome (MetS). While loss of lean body mass (LBM) compromises muscular strength and quality of life, MetS increases the risk of cardiovascular disease and may influence cancer recurrence. Exercise can improve LBM and strength, and may serve as an alternative to the pharmacological management of MetS in PCS on ADT. Prior exercise interventions in PCS on ADT have been effective at enhancing strength, but only marginally effective at enhancing body composition and ameliorating cardiometabolic risk factors. This pilot trial aims to improve on existing interventions by employing periodised resistance training (RT) to counter sarcopenic obesity in PCS on ADT. Secondary aims compare intervention effects on cardiometabolic, physical function, quality of life and molecular skeletal muscle changes. An exploratory aim examines if protein supplementation (PS) in combination with RT elicits greater changes in these outcomes. Methods and analysis A 2×2 experimental design is used in 32 PCS on ADT across a 12-week intervention period. Participants are randomised to resistance training and protein supplementation (RTPS), RT, PS or control. RT and RTPS groups perform supervised RT three times per week for 12 weeks, while PS and RTPS groups receive 50 g whey protein per day. This pilot intervention applies a multilayered approach to ameliorate detrimental cardiometabolic effects of ADT while investigating molecular mechanisms underlying skeletal muscle changes in PCS. Ethics and dissemination This trial was approved by the University of Southern California Institutional Review Board (HS-13–00315). Results from this trial will be communicated in peer-reviewed publications and scientific presentations. Trial registration number NCT01909440; Pre-results.

Purpose: To quantify the benefit of adaptive fractionation, through both theoretical test cases and patient data. Methods: We consider the effect of delivering a different fraction size based on the changes observed in the patient anatomy. Given that a fixed prescription dose must be delivered to the tumor over the course of the treatment, we find that adaptively varying the fraction size results in a lower cumulative dose to a primary organ‐at‐risk (OAR). We construct a one dimensional theoretical example by randomly varying the distance between the tumor and OAR, and simulate the benefit of adaptive fractionation in such a setting. Next, we test our methodology using contoured daily CTimages from 5 prostate patients. Results: For the theoretical example, we found about a 10% decrease in dose to the OAR when using a uniformly distributed motion model and a 20% daily fraction size deviation. In general, the amount of decrease in dose to the OAR varied significantly (5–85%) for these theoretical test cases depending on the amount of motion in the anatomy, the number of fractions, and the range of fraction sizes allowed. Preliminary results from the prostate patients indicate an average reduction in dose to the rectum of 1.4%, 3.5%, and 7.0% when using 20%, 50%, and 100% daily fraction size deviations, respectively. Conclusions: Qualitatively, the theoretical example indicates that adaptive fractionation is beneficial for disease sites in which there is significant inter‐fractional motion. We also expect greater benefit when using many fractions and allowing for large daily fraction size deviations. For the prostate disease site in particular, we find that adaptive fractionation is beneficial only when allowing large daily fraction size deviations. Further research quantifying the gain for disease sites that exhibit significant inter‐fractional motion, such as rectal and cervical cancers, would be useful. Partially supported by Siemens.

Purpose To develop and evaluate an examination consisting of magnetic resonance (MR) fingerprinting-based T1, T2, and standard apparent diffusion coefficient (ADC) mapping for multiparametric characterization of prostate disease. Materials and Methods This institutional review board-approved, HIPAA-compliant retrospective study of prospectively collected data included 140 patients suspected of having prostate cancer. T1 and T2 mapping was performed with fast imaging with steady-state precession-based MR fingerprinting with ADC mapping. Regions of interest were drawn by two independent readers in peripheral zone lesions and normal-appearing peripheral zone (NPZ) tissue identified on clinical images. T1, T2, and ADC were recorded for each region. Histopathologic correlation was based on systematic transrectal biopsy or cognitively targeted biopsy results, if available. Generalized estimating equations logistic regression was used to assess T1, T2, and ADC in the differentiation of (a) cancer versus NPZ, (b) cancer versus prostatitis, (c) prostatitis versus NPZ, and (d) high- or intermediate-grade tumors versus low-grade tumors. Analysis was performed for all lesions and repeated in a targeted biopsy subset. Discriminating ability was evaluated by using the area under the receiver operating characteristic curve (AUC). Results In this study, 109 lesions were analyzed, including 39 with cognitively targeted sampling. T1, T2, and ADC from cancer (mean, 1628 msec ± 344, 73 msec ± 27, and 0.773 × 10

ObjectivesTo determine whetherETS-related gene(ERG) expression can be used as a biomarker to predict biochemical recurrence and prostate cancer-specific death in patients with high Gleason grade prostate cancer treated with androgen deprivation therapy (ADT) as monotherapy.MethodsA multicentre retrospective cohort study identifying 149 patients treated with primary ADT for metastatic or non-metastatic prostate cancer with Gleason score 8–10 between 1999 and 2006. Patients planned for adjuvant radiotherapy at diagnosis were excluded. Age at diagnosis, ethnicity, prostate-specific antigen and Charlson-comorbidity score were recorded. Prostatic tissue acquired at biopsy or transurethral resection surgery was assessed for immunohistochemical expression ofERG. Failure of ADT defined as prostate specific antigen nadir +2. Vital status and death certification data determined using the UK National Cancer Registry. Primary outcome measures were overall survival (OS) and prostate cancer specific survival (CSS). Secondary outcome was biochemical recurrence-free survival (BRFS).ResultsThe median OS of our cohort was 60.2 months (CI 52.0 to 68.3).ERGexpression observed in 51/149 cases (34%). Multivariate Cox proportional hazards analysis showed no significant association betweenERGexpression and OS (p=0.41), CSS (p=0.92) and BRFS (p=0.31). Cox regression analysis showed Gleason score (p=0.003) and metastatic status (p-5) to be the only significant predictors of prostate CSS.ConclusionsNo significant association was found betweenERGstatus and any of our outcome measures. Despite a limited sample size, our results suggest thatERGdoes not appear to be a useful biomarker in predicting response to ADT in patients with high risk prostate cancer.

Resume But Decrire les medicaments utilises dans le traitement hormonal (hormonotherapie) du cancer de la prostate. Materiel Recherche bibliographique a partir de la base de donnees Medline (National Library of Medicine, outil PubMed), des sites de l’HAS et de l’ANSM. La recherche etait centree sur les caracteristiques, le mode d’action, l’efficacite et les effets secondaires des differentes classes de medicaments concernees. Resultats Les analogues de la LHRH et les anti-androgenes demeurent la pierre angulaire dans la prise en charge du cancer de la prostate pour les stades localement evolues, metastatiques ou en cas de recidive de la maladie. Des nouvelles classes de medicaments ont emerge recemment (inhibiteur de la synthese des androgenes, nouveaux anti-androgenes) et ont permis de repousser les limites de l’hormonoresistance et de definir le concept de resistance a la castration. Conclusion Le traitement hormonal du cancer de la prostate s’est enrichi de nouvelles classes therapeutiques qui vont changer la prise en charge du cancer de la prostate dans les prochaines annees ou l’urologue doit prendre toute sa place.

Many men develop urinary incontinence following prostate disease or surgery. Men with urinary incontinence use strategies to manage urinary incontinence in their daily lives, often with minimal assistance from health professionals. Much of the available information and advice offered to men about daily-living management of urinary incontinence have been adapted from information relating to management difficulties experienced by women. This study explored strategies used by community-dwelling men to manage urinary incontinence in their daily lives. Men with self-reported urinary incontinence were recruited from clinical and non-clinical settings. A researcher-developed survey was used to identify type, severity and duration of urinary incontinence, and the strategies men used to manage urinary incontinence in daily living. Sixty-one items, grouped according to functional strategies, asked how often each strategy was used to manage urinary incontinence. A response rate of 66% was achieved with 103 men completing a survey. The findings of this study can be used by urology nurses to ensure continence education for men with urinary incontinence addresses areas that are of most importance, as well addressing their specific needs.

Resume But Determiner les performances diagnostiques et l’acceptabilite d’une methode non invasive de l’evaluation de l’obstruction sous-vesicale, le penile cuff-test (PCT), comparativement a l’etude pression-debit (EPD), methode de reference. Materiel Etude prospective monocentrique comparant les categories « obstrue », « non obstrue » ou « equivoque » tirees des EPD et des PCT, chez 30 patients presentant des symptomes du bas appareil urinaire. Pour le cuff-test , un brassard place autour du penis se gonfle automatiquement lors de la miction jusqu’a interrompre le jet urinaire. La pression du brassard necessaire a l’interruption du debit reflete la pression vesicale isovolumetrique. Pour l’interpretation, la pression d’interruption maximale et le debit maximum sont automatiquement reportes sur un nomogramme specifique. Resultats Les EPD ont classe 11 patients (39 %) dans la categorie obstruee, six patients (22 %) dans la categorie non obstruee et 11 patients (39 %) dans la categorie equivoque. Dans 61 % de cas, le patient etait classe dans la meme categorie par les deux examens. La valeur predictive positive « obstrue » du cuff-test etait de 82 % et la valeur predictive negative « non obstrue-equivoque » etait de 88 %. La mediane de l’echelle visuelle analogique penibilite etait inferieure pour le cuff-test a 1/10 (0–3) vs 5/10 (2–10) pour l’EPD, et ce maniere statistiquement significative ( p = 0,004). Conclusion Le cuff-test apparaissait etre une technique alternative credible a l’etude pression debit formelle. Ses valeurs predictives etaient bonnes et sa tolerance meilleure.

Résumé Objectif Évaluer prospectivement les résultats fonctionnels de la thermothérapie prostatique par radiofréquence (Prostiva©) sur la gêne urinaire et la vie sexuelle dans le cadre du traitement d’une hypertrophie bénigne de la prostate (HBP) symptomatique non compliquée résistante aux traitements médicamenteux. Patients et méthodes Les patients répondant aux critères d’éligibilité à ce traitement édités selon la HAS ont été traités dans notre unité d’urologie. Ils ont été convoqués de façon systématique à un mois pour un examen clinique et paraclinique (débit urinaire maximum [Qmax], résidu postmictionnel [RPM], International Prostate Symptom Score [IPSS]). Ils ont été contactés en décembre 2009 et soumis à un hétéroquestionnaire téléphonique portant sur des scores de gêne urinaire (IPSS), de qualité de vie (question 8 de l’IPSS), d’évaluation des fonctions sexuelles (IIEF, DAN SEX), et d’évaluation subjective du traitement (échelle de Likert). Résultats De décembre 2006 à janvier 2009, 20 patients (âge médian: 63 ans) ont été traités par Prostiva©. Quatre patients ont présenté une rétention aiguë d’urine dans le postopératoire immédiat nécessitant un sondage vésical en urgence. Nous avons réalisé l’évaluation systématique de l’ensemble des patients à un mois et en décembre 2009. Le suivi médian était de 20,6 mois (valeurs maximales [12–37 mois]). On a constaté une amélioration significative de l’IPSS (−6,7 points; IC95= [−10,3; −3,1]), une amélioration des fonctions sexuelles, des scores de qualité de vie, et un sentiment d’amélioration globale des symptômes urinaires (+ 1,08 = amélioré sur l’échelle de Likert). Quatre patients ont été considérés comme des échecs du Prostiva©: trois patients ayant repris un traitement médicamenteux, un patient ayant bénéficié d’une résection de la prostate. Conclusion Notre étude monocentrique réalisée chez des patients sélectionnés selon les critères de l’HAS a conforté les résultats de la littérature avec des résultats positifs sur la gêne urinaire, une faible morbidité et une amélioration de la qualité de vie déclarée. Elle a démontré l’innocuité de la thermothérapie sur la sexualité des patients et mieux encore, l’impact positif du traitement sur la qualité des érections et la satisfaction des rapports.

Resume Objectif Evaluer la valeur des biopsies ciblees par IRM multiparametrique chez les patients ayant une suspicion de cancer prostatique a faible risque de d’Amico. Patients et methode Les patients ayant un PSA compris entre 4 et 10 ng/mL et un toucher rectal normal ont ete prospectivement inclus. Une IRM multiparametrique de la prostate etait realisee systematiquement avant les biopsies. Douze biopsies systematisees ont ete realisees, avec des prelevements additionnels dans chaque cible identifiee a l’IRM. Les taux et les caracteristiques des cancers detectes ont ete compares entre les deux protocoles biopsiques. Un micro foyer cancereux (MFC) etait defini par l’existence de moins de 4 mm de cancer Gleason 3 + 3 sur une seule biopsie. Resultats Soixante et onze patients ont ete inclus. Le taux global de detection etait de 53 % (38/71). Il etait de 70 % (26/37) en presence de cible(s) IRM, versus 35 % (12/34) en l’absence de cible ( p = 0,004). Les biopsies ciblees seules ont detecte trois cancers, dont aucun MFC. Les biopsies systematisees seules en ont detecte 14, dont dix MFC (71 %). Chez 21 patients, le cancer a ete detecte a la fois par les biopsies ciblees et systematisees. Le score de Gleason au niveau de la cible correspondait au score de Gleason maximal dans 90 % des cas. Il etait eleve (> 6) chez 76 % (16/21) des patients. Conclusion Les biopsies ciblees par IRM ont detecte moins de micros foyers cancereux biopsiques que les biopsies systematisees. En revanche, elles ne semblaient pas diminuer la detection des cancers cliniquement significatifs.