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Objective: Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design: MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Results: Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. Conclusion: This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative. [ABSTRACT FROM AUTHOR]

Laura B Oswald,1 Frank A Schumacher,2 Brian D Gonzalez,1 Kelvin A Moses,3 David F Penson,3,4 Alicia K Morgans2 1Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL, USA; 2Department of Medicine (Hematology and Oncology), Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 3Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA; 4Department of Urology, VA Tennessee Valley Geriatric Research, Education, and Clinical Center (GRECC), Nashville, TN, USACorrespondence: Alicia K MorgansNorthwestern University Feinberg School of Medicine, 676 N. Saint Clair, Suite 850., Chicago, IL 60611, USATel +1312-695-2381Email Alicia.Morgans@northwestern.eduObjective: Metastatic prostate cancer (mPCa) patients often make complicated treatment decisions, yet decision aids to facilitate shared decision-making for mPCa are uncommon. To inform the development of patient-centered mPCa decision aids, we examined what mPCa survivors considered most important when making treatment decisions.Methods: Using an exploratory sequential approach, we conducted three focus groups with 14 advanced prostate cancer survivors (n=5, n=3, n=6 in each group) to identify considerations for making treatment decisions. Focus groups were audio-recorded and transcribed, and we identified qualitative themes. We then developed a quantitative survey to assess the importance of each theme and administered the survey to mPCa survivors (N=100). We used relative frequencies to determine the most strongly endorsed items and chi-squared and Fisher’s exact tests to assess associations with participant characteristics.Results: Focus groups yielded 11 themes, and the resulting survey included 20 items. The most strongly endorsed mPCa treatment considerations were: relying on physician’s treatment recommendations (79% strongly agree); wanting to feel well enough to spend quality time with loved ones (72% strongly agree); the importance of dying in a manner consistent with one’s wishes (70% strongly agree); hoping to eliminate cancer completely (68% strongly agree); and optimizing treatment efficacy (65% strongly agree). Age, race, marital status, employment status, and self-reported health were related to how strongly men endorsed various considerations for mPCa treatment decision-making.Conclusion: We identified multiple considerations that mPCa survivors appraised when making treatment decisions. These data may inform the development of patient-centered decision aids for mPCa.Keywords: decision-making, focus groups, metastasis, prostate cancer, quality of life

Focuses on the task of maintaining and improving health related quality of life (HRQOL) in the management of prostate cancer. Principal challenge of assessing HRQOL; Established instruments for HRQOL; Discussion on the prostate-specific domains of HRQOL.

Health-Related Quality of Life (HRQOL) is an important outcome measure in the study of prostate cancer. There are few data regarding the effect of sociodemographic variables, such as insurance status, educational level, marital status or income, on HRQOL. We examined whether these or other sociodemographic and clinical variables are predictive of HRQOL outcomes using an observational database of prostate cancer patients accrued from a wide array of clinical practice settings. We studied 131 patients with newly-diagnosed prostate cancer who had been followed for at least nine months. Patients were enrolled in CaPSURETM, a large, observational database of patients with prostate cancer. General and disease-specific HRQOL were measured with established, validated instruments at diagnosis and nine months later. Sociodemographic data and co-morbidity counts were recorded at baseline. Multivariate regression analysis was used to determine whether sociodemographic or clinical variables were predictive of baseline HRQOL or HRQOL changes during the study period. Several sociodemographic and clinical variables demonstrated significant associations with HRQOL. We found improvements in general and disease-specific domains of HRQOL during the nine months after diagnosis. For married patients, Emotional Well-Being and Family Functioning scores were better at baseline (+11.8, P<0.02), but Family Functioning declined over the nine month study period (-18.5, P=0.0006). Older patients had slightly better baseline performance in several domains of HRQOL, but experienced greater HRQOL decrements over time than did younger patients. Increasing comorbidity was associated with worse baseline general HRQOL. Early tumor stage was predictive of better scores in general HRQOL domains at baseline. Limited palpable disease stage (T2A/T2B) was predictive of worse Sexual Function and Sexual Bother at nine months (-8.6, P=0.04; -24, P=0.008). After initial decreases, patients appear... [ABSTRACT FROM AUTHOR]

Sun Hee Rim1, Ingrid J Hall1, Megan E Fairweather2, Catherine R Fedorenko2, Donatus U Ekwueme1, Judith Lee Smith1, Ian M Thompson3, Thomas E Keane4, David F Penson5, Carol M Moinpour2, Steven B Zeliadt2,6, Scott D Ramsey21Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, GA, USA; 2Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; 3Department of Urology, University of Texas Health Science Center at San Antonio, TX, USA; 4Urology Services, Medical University of South Carolina, Charleston, SC, USA; 5Vanderbilt Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN, USA; 6Health Services Research and Development Center of Excellence, VA Puget Sound Health Care System, Seattle, WA, USAAbstract: Prostate cancer is the most commonly diagnosed cancer among American men. The multiple treatment options for localized prostate cancer and potential side effects can complicate the decision-making process. We describe the level of engagement and communication among the patient, family member, and physician (the decision-making “triad”) in the decision process prior to treatment. Using the Family and Cancer Therapy Selection (FACTS) study baseline survey data, we note racial/ethnic variations in communication among the triad. Sensitivity to and awareness of decision-making styles of both the patient and their family member (or caregiver) may enable clinicians to positively influence communication exchanges about important clinical decisions.Keywords: decision-making, treatment-related decisions, ethnicity

Investigates the cause of death in prostate cancer. Assessment of the radiation therapy; Observation of the coding systems; Identification of myocardial infarction.

Abstract Background Established risk factors for prostate cancer have not translated to effective prevention or adjuvant care strategies. Several epidemiologic studies suggest greater body adiposity may be a modifiable risk factor for high-grade (Gleason 7, Gleason 8-10) prostate cancer and prostate cancer mortality. However, BMI only approximates body adiposity, and may be confounded by centralized fat deposition or lean body mass in older men. Our objective was to use bioelectric impedance analysis (BIA) to measure body composition and determine the association between prostate cancer and total body fat mass (FM) fat-free mass (FFM), and percent body fat (%BF), and which body composition measure mediated the association between BMI or waist circumference (WC) with prostate cancer. Methods The study used a multi-centered recruitment protocol targeting men scheduled for prostate biopsy. Men without prostate cancer at biopsy served as controls (n = 1057). Prostate cancer cases were classified as having Gleason 6 (n = 402), Gleason 7 (n = 272), or Gleason 8-10 (n = 135) cancer. BIA and body size measures were ascertained by trained staff prior to diagnosis, and clinical and comorbidity status were determined by chart review. Analyses utilized multivariable linear and logistic regression. Results Body size and composition measures were not significantly associated with low-grade (Gleason 6) prostate cancer. In contrast, BMI, WC, FM, and FFM were associated with an increased risk of Gleason 7 and Gleason 8-10 prostate cancer. Furthermore, BMI and WC were no longer associated with Gleason 8-10 (ORBMI = 1.039 (1.000, 1.081), ORWC = 1.016 (0.999, 1.033), continuous scales) with control for total body FFM (ORBMI = 0.998 (0.946, 1.052), ORWC = 0.995 (0.974, 1.017)). Furthermore, increasing FFM remained significantly associated with Gleason 7 (ORFFM = 1.030 (1.008, 1.052)) and Gleason 8-10 (ORFFM = 1.044 (1.014, 1.074)) after controlling for FM. Conclusions Our results suggest that associations between BMI and WC with high-grade prostate cancer are mediated through the measurement of total body FFM. It is unlikely that FFM causes prostate cancer, but instead provides a marker of testosterone or IGF1 activities involved with retaining lean mass as men age.

Presents several lectures on male sexual disorders. Benefits of oral drug therapy for erectile dysfunction after treatment for prostrate cancer; Issues and guidelines concerning management of complicated and treatment-refractory erectile dysfunction; Association between erectile dysfunction and hypertension.

Introduction: Patient preference assessment is key to high-quality decision-making in men with prostate cancer. We aimed to determine if "phenotypes" could be identified among men with prostate cancer, with each phenotype representing a cohort with a distinct combination of preferences. We wished to learn if there was an association between phenotype and treatment selection., Methods: A prospective cohort of men with prostate cancer received a pre-visit decision aid. This software used conjoint analysis to quantify relative patient preferences for treatment-associated survival, quality of life outcomes, and recovery time. We collected patient clinical data, physician recommendation for active treatment or surveillance, and treatments received. Preferences were analyzed using latent class analysis to identify distinct classes of preference phenotypes. We compared patient characteristics and treatment choice across phenotypes, both univariately and in a multivariable logistic regression., Results: In 250 men who used the decision aid as part of routine care, latent class analysis revealed 3 phenotypic classes. Men in Class 1 had the highest concerns around recovery time and the lowest value on improving lifespan. Men in Class 2 had relatively evenly distributed concerns. Men in Class 3 had the lowest concerns around recovery time and risk of surgical complications. On multivariate analysis, treatment choice was not associated with preference-based phenotype. Only physician recommendation was associated with choice of active treatment., Conclusions: We identified the existence of 3 patient preference-based phenotypes in men with prostate cancer. Each phenotype had a unique combination of trade-offs when considering competing treatment outcomes. These phenotypes were not associated with treatment. Physician recommendation was the only factor determining treatment choice.

Importance: Specialist palliative care benefits patients undergoing medical treatment of cancer; however, data are lacking on whether patients undergoing surgery for cancer similarly benefit from specialist palliative care., Objective: To determine the effect of a specialist palliative care intervention on patients undergoing surgery for cure or durable control of cancer., Design, Setting, and Participants: This was a single-center randomized clinical trial conducted from March 1, 2018, to October 28, 2021. Patients scheduled for specified intra-abdominal cancer operations were recruited from an academic urban referral center in the Southeastern US., Intervention: Preoperative consultation with palliative care specialists and postoperative inpatient and outpatient palliative care follow-up for 90 days., Main Outcomes and Measures: The prespecified primary end point was physical and functional quality of life (QoL) at postoperative day (POD) 90, measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI), which is scored on a range of 0 to 56 with higher scores representing higher physical and functional QoL. Prespecified secondary end points included overall QoL at POD 90 measured by FACT-G, days alive at home until POD 90, and 1-year overall survival. Multivariable proportional odds logistic regression and Cox proportional hazards regression models were used to test the hypothesis that the intervention improved each of these end points relative to usual care in an intention-to-treat analysis., Results: A total of 235 eligible patients (median [IQR] age, 65.0 [56.8-71.1] years; 141 male [60.0%]) were randomly assigned to the intervention or usual care group in a 1:1 ratio. Specialist palliative care was received by 114 patients (97%) in the intervention group and 1 patient (1%) in the usual care group. Adjusted median scores on the FACT-G TOI measure of physical and functional QoL did not differ between groups (intervention score, 46.77; 95% CI, 44.18-49.04; usual care score, 46.23; 95% CI, 43.08-48.14; P = .46). Intervention vs usual care group odds ratio (OR) was 1.17 (95% CI, 0.77-1.80). Palliative care did not improve overall QoL measured by the FACT-G score (intervention vs usual care OR, 1.09; 95% CI, 0.75-1.58), days alive at home (OR, 0.87; 95% CI, 0.69-1.11), or 1-year overall survival (hazard ratio, 0.97; 95% CI, 0.50-1.88)., Conclusions and Relevance: This randomized clinical trial showed no evidence that early specialist palliative care improves the QoL of patients undergoing nonpalliative cancer operations., Trial Registration: ClinicalTrials.gov Identifier: NCT03436290.

What Is This Summary About?: This is a summary of a research article originally published in European Journal of Cancer . The PROSPER study involved men who had a type of advanced prostate cancer called nonmetastatic castration-resistant prostate cancer (nmCRPC). In men with nmCRPC, their cancer has progressed on traditional hormone therapy but scans show that it has not spread to other parts of the body. The main results of the PROSPER study showed that patients treated with enzalutamide lived longer than patients treated with placebo. For this analysis, researchers looked at whether this was different depending on patients' traits., What Were the Results?: Researchers found that age and location did not affect how long patients lived when treated with enzalutamide. They found three patient traits that did make a difference. Being able to carry out daily activities, low prostate-specific antigen level (PSA level), and receiving no other prostate cancer treatments after the study meant that patients were more likely to live longer., What Do the Results of the Study Mean?: Patients with nmCRPC treated with enzalutamide lived longer than patients treated with placebo. Age and location did not affect how long these patients lived, but other traits did. Clinical Trial Registration : NCT02003924 (ClinicalTrials.gov).

Purpose: Financial toxicity is an underappreciated component of cancer survivorship. Treatment-specific out-of-pocket costs for patients undergoing localized prostate cancer treatment have not, to date, been described and may influence patient's decision making., Methods: We performed a retrospective cohort study among commercially-insured patients in the United States with incident prostate cancer from 2013 to 2018. We captured out-of-pocket and total costs in the year following diagnosis and compared these between patients receiving radical prostatectomy, radiotherapy, and no local treatment using propensity-score weighting adjusting for patient demographics and pre-diagnosis health utilization costs., Results: Among 30,360 included men [median age 59 years, 83% Charlson score 0], 15,854 underwent surgery, 5,265 radiotherapy, and 9,241 no local therapy in the year following diagnosis. In the 6-months preceding diagnosis, median overall and out-of-pocket health care costs were $2022 (interquartile range $3778) and $466 (interquartile range $781), respectively. Following propensity-score weighting, out-of-pocket costs were significantly lower for patients who received no active treatment (adjusted cost $1746, 95% confidence interval [CI] $1704-1788), followed by those who underwent surgery ($2983, 95% CI $2832-3142, P < 0.001), and those who underwent radiation ($3139, 95% CI $2939-3353, P < 0.001) in the 6-months following diagnosis. Similar patterns were seen with out-of-pocket costs 6 to 12 months following index, with overall costs, and with costs attributable to inpatient, outpatient medical, and outpatient pharmacy services., Conclusions: Among commercially insured men with incident prostate cancer, active treatment with surgery or radiotherapy was associated with significantly higher out-of-pocket costs versus those who received no treatment, with little difference observed between treatment approaches., Competing Interests: Conflict of interest The authors attest they have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Enzalutamide combined with androgen deprivation therapy (ADT) significantly prolonged metastasis-free survival and overall survival (OS) versus ADT alone in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with rapidly rising prostate-specific antigen (PSA). The objective of this post hoc analysis of the PROSPER trial is to evaluate OS benefit and safety of enzalutamide in patients across age and regional subgroups., Patients and Methods: Eligible men with nmCRPC, PSA doubling time ≤10 months and PSA ≥2 ng/mL with continued ADT use were randomised 2:1 to enzalutamide 160 mg or placebo. OS and safety were examined by age (<70 vs ≥70 years) and region (North America, Europe, Asia or the rest of the world). The impact of prior and subsequent therapy was also examined., Results: In total, 1401 men were enrolled (median age, 74 years). Enzalutamide plus ADT reduced the risk of death, independent of age or region. Multivariate analyses identified Eastern Cooperative Oncology Group (ECOG) status (P < 0.0001), log (PSA; P = 0.0002) and subsequent therapy (P < 0.0001) as statistically significant factors impacting OS. Safety was consistent across age and regional subgroups. Any grade treatment-emergent adverse events were similar across age groups, were more common in the placebo group and had regional variation., Conclusions: In men with nmCRPC and rapidly rising PSA, the benefit and safety of enzalutamide were consistent across age and regional subgroups. Variables impacting OS included ECOG status, log (PSA) and subsequent therapy. CLINICALTRIALS., Gov Identifier: NCT02003924., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Cora N. Sternberg served as a consultant for Janssen-Cilag, Astellas Pharma Inc., Sanofi–Genzyme, Novartis, Bayer, Pfizer Inc., Merck, MSD, AstraZeneca, Immunomedics (now Gilead), Janssen, Foundation Medicine, UroToday and Medscape and has received prior institutional funding from Cougar Biotechnology (now Janssen), Medivation (now Pfizer), Clovis Oncology and Roche-Genentech.Ugo De Giorgi served as a consultant for Janssen, Astellas Pharma Inc., Sanofi, Bayer, Pfizer Inc., BMS, Novartis, Ipsen and Merck. Neal D. Shore served as a consultant for Abbvie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boston Scientific, Clovis Oncology, Cold Genesys, Dendreon, Exact Imaging, Exact Sciences, FerGene, Foundation Medicine, Genesis Care, Invitae, Janssen, MDxhealth, Merck, Myovant, Myriad, Nymox, Pacific Edge, Pfizer Inc., Phosphorous, Propella, PreView, Sanofi Genzyme, Speciality Networks, Sesen Bio, Tolmar and Urogen. Karim Fizazi served as a consultant for Janssen Oncology, Bayer, Astellas Pharma Inc., Sanofi, Orion Pharma GmbH, Curevac, AstraZeneca, ESSA Pharmaceuticals, Roche/Genentech, Clovis Oncology and Amgen, received money for travel/accommodation expenses from Amgen and has received honoraria from Janssen, Sanofi, Astellas Pharma Inc. and Merck. Bertrand Tombal received personal fees and non-financial support from Amgen, Astellas Pharma Inc., Bayer, Ferring, Janssen and Sanofi; personal fees from Pfizer, Steba Biotech and Takeda and grants from Ferring. David Penson reported no conflict of interest. Fred Saad served as a consultant for Astellas Pharma Inc., Janssen Oncology, Sanofi and AstraZeneca/MedImmune, received honoraria from Astellas Pharma Inc., Janssen Oncology, Sanofi, Bayer and AstraZeneca, received institutional funding from Astellas Pharma Inc., Bayer, Janssen Oncology, Sanofi, Myovant Sciences and AstraZeneca. Eleni Efstathiou received honoraria from Janssen-Cilag, Sanofi and Takeda, served as a consultant for Janssen-Cilag, Sanofi, Astellas Pharma Inc., Bayer, AstraZeneca, Merck Sharp & Dohme, Innocrin Pharma, Takeda and Tolmar, member of the Speakers Bureau for Janssen-Cilag; received research funding from Janssen-Cilag, Sanofi and Astellas Pharma Inc. Katarzyna Madziarska reported no conflict of interest. Joyce Steinberg: employee of Astellas Pharma, Inc. and has an immediate family member with stock ownership in Amgen. Jennifer Sugg: employee of Astellas Pharma, Inc., with stock ownership in AstraZeneca. Xun Lin and Qi Shen: employees and stockholders of Pfizer Inc. Maha Hussain served as a consultant or in an advisory role for AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo Company, Genentech, Janssen and Pfizer Inc., received honoraria and/or travel expenses for educational functions/lectures from Astellas Pharma Inc., AstraZeneca Pharma, Bayer, Genentech/Roche, MLI PeerView, OncLive, Physicians’ Education Resource LLC, Phillips Gilmore Oncology, projects in Knowledge, Research to Practice, Sanofi-Genzyme, UroToday and Precisca, and received institutional research funding from AstraZeneca, Bayer, Genentech, Prostate Cancer Clinical Trials Consortium (PCCTC), Pfizer Inc. and Arvinas., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: Magnetic resonance imaging-guided transurethral ultrasound ablation uses directional thermal ultrasound under magnetic resonance imaging thermometry feedback control for prostatic ablation. We report 12-month outcomes from a prospective multicenter trial (TACT)., Materials and Methods: A total of 115 men with favorable to intermediate risk prostate cancer across 13 centers were treated with whole gland ablation sparing the urethra and apical sphincter. The co-primary 12-month endpoints were safety and efficacy., Results: In all, 72 (63%) had grade group 2 and 77 (67%) had NCCN® intermediate risk disease. Median treatment delivery time was 51 minutes with 98% (IQR 95-99) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on magnetic resonance imaging thermometry. Grade 3 adverse events occurred in 9 (8%) men. The primary endpoint (U.S. Food and Drug Administration mandated) of prostate specific antigen reduction ≥75% was achieved in 110 of 115 (96%) with median prostate specific antigen reduction of 95% and nadir of 0.34 ng/ml. Median prostate volume decreased from 37 to 3 cc. Among 68 men with pretreatment grade group 2 disease, 52 (79%) were free of grade group 2 disease on 12-month biopsy. Of 111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer. Erections (International Index of Erectile Function question 2 score 2 or greater) were maintained/regained in 69 of 92 (75%). Multivariate predictors of persistent grade group 2 at 12 months included intraprostatic calcifications at screening, suboptimal magnetic resonance imaging thermal coverage of target volume and a PI-RADS™ 3 or greater lesion at 12-month magnetic resonance imaging (p <0.05)., Conclusions: The TACT study of magnetic resonance imaging-guided transurethral ultrasound whole gland ablation in men with localized prostate cancer demonstrated effective tissue ablation and prostate specific antigen reduction with low rates of toxicity and residual disease.

Purpose: The advanced prostate cancer therapeutic landscape has changed dramatically in the last several years, resulting in improved overall survival of patients with castration naïve and castration resistant disease. The evolution and development of novel next generation imaging techniques will affect diagnostic and therapeutic decision making. Clinicians must navigate when and which next generation imaging techniques to use and how to adjust treatment strategies based on the results, often in the absence of correlative therapeutic data. Therefore, guidance is needed based on best available information and current clinical experience., Materials and Methods: The RADAR (Radiographic Assessments for Detection of Advanced Recurrence) III Group convened to offer guidance on the use of next generation imaging to stage prostate cancer based on available data and clinical experience. The group also discussed the potential impact of next generation imaging on treatment options based on earlier detection of disease., Results: The group unanimously agreed that progression to metastatic disease is a seminal event for patient treatment. Next generation imaging techniques are able to detect previously undetectable metastases, which could redefine the phases of prostate cancer progression. Thus, earlier systemic or locally directed treatment may positively alter patient outcomes., Conclusions: The RADAR III Group recommends next generation imaging techniques in select patients in whom disease progression is suspected based on laboratory (biomarker) values, comorbidities and symptoms. Currently 18 F-fluciclovine and 68 Ga prostate specific membrane antigen positron emission tomography/computerized tomography are the next generation imaging agents with a favorable combination of availability, specificity and sensitivity. There is ongoing research of additional next generation imaging technologies, which may offer improved diagnostic accuracy and therapeutic options. As next generation imaging techniques evolve and presumably result in improved global accessibility, clinician ability to detect micrometastases may be enhanced for decision making and patient outcomes.

Background: In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study., Methods: In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo. Randomisation was stratified by prostate-specific antigen doubling time and baseline use of a bone-targeting agent. The primary endpoint was metastasis-free survival, reported elsewhere. Secondary efficacy endpoints, reported here, were pain progression (assessed by the Brief Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-PR25], the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale [EQ-5D-FL, EQ-VAS], and the Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaires). Patients completed questionnaires at baseline, week 17, and every 16 weeks thereafter until treatment discontinuation. We used predefined questionnaire thresholds to identify clinically meaningful changes. Enrolment for PROSPER is complete and follow-up continues. This trial is registered with ClinicalTrials.gov, number NCT02003924., Findings: Between Nov 26, 2013, and June 28, 2017, 1401 patients were enrolled and randomly assigned to receive enzalutamide (n=933) or placebo (n=468). Median follow-up was 18·5 months (IQR 10·7-29·2) in the enzalutamide group and 15·1 months (7·4-25·9) in the placebo group. Patient-reported outcome scores at baseline were similar between groups. Changes in least squares mean from baseline to week 97 favoured enzalutamide versus placebo for FACT-P social and family wellbeing (0·30 [95% CI -0·25 to 0·85] vs -0·64 [-1·51 to 0·24]; difference 0·94 [95% CI 0·02 to 1·85]; p=0·045) and disfavoured enzalutamide versus placebo for EORTC QLQ-PR25 hormonal treatment-related symptoms (1·55 [0·26 to 2·83) vs -1·83 [-3·86 to 0·20]; difference 3·38 [1·24 to 5·51]; p=0·0020); neither of these changes were clinically meaningful. No significant differences were observed between treatments for changes from baseline to week 97 in any other patient-reported outcome score. Time to clinically meaningful pain progression as assessed by BPI-SF pain severity was longer with enzalutamide than with placebo (median 36·83 months, [95% CI 34·69 to not reached [NR] vs NR; hazard ratio [HR] 0·75 [95% CI 0·57 to 0·97]; p=0·028); there was no significant difference for BPI-SF item 3 or pain interference. Time to clinically meaningful symptom worsening was longer with enzalutamide than with placebo for EORTC QLQ-PR25 urinary symptoms (median 36·86 months [95% CI 33·35 to NR] vs 25·86 [18·53 to 29·47]; HR 0·58 [95% CI 0·46 to 0·72]; p<0·0001) and bowel symptoms (33·15 [29·50 to NR] vs 25·89 [18·43 to 29·67]; 0·72 [0·59 to 0·89]; p=0·0018), and clinically meaningful health-related quality of life as assessed by FACT-P total score (22·11 [18·63 to 25·86] vs 18·43 [14·85-19·35]; 0·83 [0·69 to 0·99]; p=0·037), emotional wellbeing (36·73 [33·12 to 38·21] vs 29·47 [22·18 to 33·15]; 0·69 [0·55 to 0·86]; p=0·0008), and prostate cancer subscale (18·43 [14·85 to 18·66] vs 14·69 [11·07 to 16·20]; 0·79 [0·67 to 0·93]; p=0·0042), although there was no significant difference for other FACT-P scores. Time to clinically meaningful deterioration in EORTC QLQ-PR25 hormonal treatment-related symptoms was shorter with enzalutamide than with placebo (median 33·15 months [95% CI 29·60 to NR] vs 36·83 [29·47 to NR]; HR 1·29 [95% CI 1·02 to 1·63]; p=0·035). Time to deterioration of EQ-VAS was significantly longer for enzalutamide than for placebo (median 22·11 months [95% CI 18·46 to 25·66] vs 14·75 [11·07 to 18·17]; HR 0·75 [95% CI 0·63 to 0·90]; p=0·0013)., Interpretation: Patients with non-metastatic, castration-resistant prostate cancer receiving enzalutamide had longer metastasis-free survival than did those who received placebo, while maintaining low pain levels and prostate cancer symptom burden and high health-related quality of life. Enzalutamide showed a clinical benefit by delaying pain progression, symptom worsening, and decrease in functional status, compared with placebo. These findings suggest that enzalutamide is a treatment option that should be discussed with patients presenting with high-risk, non- metastatic, castration-resistant prostate cancer., Funding: Astellas Pharma Inc, Medivation LLC (a Pfizer Company)., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Consolidation of physician practices by hospitals, or vertical integration, increased across all practice types in 2007-17. Rates of growth were highest among medical and surgical specialty practices and lowest among primary care practices. There was substantial variation within the specialties, ranging from 4 percentage points in dermatology to 34 percentage points in cardiology and oncology.

Context: Some of the high costs of robot-assisted radical prostatectomy (RARP), intensity-modulated radiotherapy (IMRT), and proton beam therapy may be offset by better outcomes or less resource use during the treatment episode., Objective: To systematically review the literature to identify the key economic trade-offs implicit in a particular treatment choice for prostate cancer., Evidence Acquisition: We systematically reviewed the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement and protocol. We searched Medline, Embase, and Web of Science for articles published between January 2001 and July 2016, which compared the treatment costs of RARP, IMRT, or proton beam therapy to the standard treatment. We identified 37, nine, and three studies, respectively., Evidence Synthesis: RARP is costlier than radical retropubic prostatectomy for hospitals and payers. However, RARP has the potential for a moderate cost advantage for payers and society over a longer time horizon when optimal cancer and quality-of-life outcomes are achieved. IMRT is more expensive from a payer's perspective compared with three-dimensional conformal radiotherapy, but also more cost effective when defined by an incremental cost effectiveness ratio <$50 000 per quality-adjusted life year. Proton beam therapy is costlier than IMRT and its cost effectiveness remains unclear given the limited comparative data on outcomes. Using the Grades of Recommendation, Assessment, Development and Evaluation approach, the quality of evidence was low for RARP and IMRT, and very low for proton beam therapy., Conclusions: Treatment with new versus traditional technologies is costlier. However, given the low quality of evidence and the inconsistencies across studies, the precise difference in costs remains unclear. Attempts to estimate whether this increased cost is worth the expense are hampered by the uncertainty surrounding improvements in outcomes, such as cancer control and side effects of treatment. If the new technologies can consistently achieve better outcomes, then they may be cost effective., Patient Summary: We review the cost and cost effectiveness of robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and proton beam therapy in prostate cancer treatment. These technologies are costlier than their traditional counterparts. It remains unclear whether their use is associated with improved cure and reduced morbidity, and whether the increased cost is worth the expense., (Published by Elsevier B.V.)

Despite the evidence indicating that decision aids (DA) improve informed treatment decision making for prostate cancer (PCa), physicians do not routinely recommend DAs to their patients. We conducted semi-structured interviews with urologists (n = 11), radiation oncologists (n = 12) and primary care physicians (n = 10) about their methods of educating low-risk PCa patients regarding the treatment decision, their concerns about recommending DAs, and the essential content and format considerations that need to be addressed. Physicians stressed the need for providing comprehensive patient education before the treatment decision is made and expressed concern about the current unevaluated information available on the Internet. They made recommendations for a DA that is brief, applicable to diverse populations, and that fully discloses all treatment options (including active surveillance) and their potential side effects. Echoing previous studies showing that low-risk PCa patients are making rapid and potentially uninformed treatment decisions, these results highlight the importance of providing patient education early in the decision-making process. This need may be fulfilled by a treatment DA, should physicians systematically recommend DAs to their patients. Physicians' recommendations for the inclusion of particular content and presentation methods will be important for designing a high quality DA that will be used in clinical practice., (© The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Researchers are increasingly interested in using observational data to evaluate cancer outcomes following treatment, including cancer recurrence and disease-free survival. Because population-based cancer registries do not collect recurrence data, recurrence is often imputed from health claims, primarily by identifying later cancer treatments after initial treatment. The validity of this approach has not been established., Research Design: We used the linked Surveillance, Epidemiology, and End Results-Medicare data to assess the sensitivity of Medicare claims for cancer recurrence in patients very likely to have had a recurrence. We selected newly diagnosed stage II/III colorectal (n=6910) and female breast cancer (n=3826) patients during 1994-2003 who received initial cancer surgery, had a treatment break, and then died from cancer in 1994-2008. We reviewed all claims from the treatment break until death for indicators of recurrence. We focused on additional cancer treatment (surgery, chemotherapy, radiation therapy) as the primary indicator, and used multivariate logistic regression analysis to evaluate patient factors associated with additional treatment. We also assessed metastasis diagnoses and end-of-life care as recurrence indicators., Results: Additional treatment was the first indicator of recurrence for 38.8% of colorectal patients and 35.2% of breast cancer patients. Patients aged 70 and older were less likely to have additional treatment (P < 0.05), in adjusted analyses. Over 20% of patients either had no recurrence indicator before death or had end-of-life care as their first indicator., Conclusions: Identifying recurrence through additional cancer treatment in Medicare claims will miss a large percentage of patients with recurrences; particularly those who are older.

Among the estimated 230,000 men diagnosed with prostate cancer in the US each year there has been a rise in the number of radical prostatectomies (RP). There is some debate over the value of immediate adjuvant therapy following RP in men with high-risk pathological features versus delayed salvage radiation therapy when signs of disease progression are observed. Thus, it would be potentially useful to inform post-RP management strategies by more clearly identifying those patients at higher risk of progression and death from prostate cancer. A 22 gene-expression assay, Decipher® (GenomeDx Biosciences), has been developed in men treated with radical prostatectomy to predict the five-year risk of metastatic prostate cancer. Published and unpublished literature was evaluated to determine the analytic validity, clinical validity and clinical utility of Decipher. Limited information is available on the analytic validity of Decipher. In both discovery and validation studies, Decipher was shown to have good performance in discriminating men with metastasis from men without metastasis five years after surgery (AUC 0.75 to 0.90). In terms of clinical utility, no evidence was found reporting improved outcomes (lower prostate cancer specific mortality and treatment related adverse effects) from using this test to guide post-operative treatment. Four studies provided weak indirect evidence of clinical utility in which 31% to 43% of post-operative treatment recommendations were changed in men with high-risk prostate cancer based on test results, with 27% to 52% of treatment recommendations changing from any treatment to no treatment.