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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.

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]

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.)

Background: Familism, the cultural value that emphasizes feelings of loyalty and dedication to one's family, has been related to both positive and negative outcomes in Hispanic cancer survivors. One potential source of observed inconsistencies may be limited attention to the family environment, as familism may be protective in a cohesive family whereas it can exacerbate distress in a conflictive family., Purpose: The current study explored the associations of familism with general and disease-specific health-related quality of life (HRQoL) in Hispanic men who completed prostate cancer (PC) treatment, and whether family cohesion may help explain these relationships., Methods: Hispanic men treated for localized PC (e.g., radiation, surgery) were enrolled in a randomized controlled stress management trial and assessed prior to randomization. Familism (familial obligation) was assessed using Sabogal's Familism Scale and family cohesion was measured using the Family Environment Scale (ranging from high to low). The sexual, urinary incontinence, and urinary obstructive/irritative domains of the Expanded Prostate Cancer Index Composite - Short Form measured disease-specific HRQoL. The physical, emotional, and functional well-being subscales of the Functional Assessment of Cancer Therapy - General captured general HRQoL. Hierarchical linear regression and the SPSS PROCESS macro were used to conduct moderation analyses, while controlling for relevant covariates., Results: Participants were 202 older men on average 65.7 years of age (SD = 8.0) who had been diagnosed with PC an average of 22 months prior to enrollment. Familism was not directly associated with general and disease-specific HRQoL. Moderation analyses revealed that greater familism was related to poorer urinary functioning in the incontinence (p = .03) and irritative/obstructive domains (p = .01), and lower emotional well-being (p = .02), particularly when family cohesion was low., Conclusions: These findings underscore the importance of considering contextual factors, such as family cohesion, in understanding the influence of familism on general and disease-specific HRQoL among Hispanic PC patients. The combined influence of familism and family cohesion predicts clinically meaningful differences in urinary functioning and emotional well-being during the posttreatment phase. Culturally sensitive psychosocial interventions to boost family cohesion and leverage the positive impact of familistic attitudes are needed to enhance HRQoL outcomes in this population., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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.