Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions.

PURPOSE: The summary presented herein covers recommendations on salvage therapy for recurrent prostate cancer intended to facilitate care decisions and aid clinicians in caring for patients who have experienced a recurrence following prior treatment with curative intent. This is Part III of a three-part series focusing on evaluation and management of suspected non-metastatic recurrence after radiotherapy (RT) and focal therapy, evaluation and management of regional recurrence, management for molecular imaging metastatic recurrence, and future directions. Please refer to Part I for discussion of treatment decision-making and Part II for discussion of treatment delivery for non-metastatic biochemical recurrence (BCR) after radical prostatectomy (RP). MATERIALS AND METHODS: The systematic review that informs this Guideline was based on searches in Ovid MEDLINE (1946 to July 21, 2022), Cochrane Central Register of Controlled Trials (through August 2022), and Cochrane Database of Systematic Reviews (through August 2022). Update searches were conducted on July 26, 2023. Searches were supplemented by reviewing electronic database reference lists of relevant articles. RESULTS: In a collaborative effort between AUA, ASTRO, and SUO, the Salvage Therapy for Prostate Cancer Guideline Panel developed evidence- and consensus-based guideline statements to provide guidance for the care of patients who experience BCR after initial definitive local therapy for clinically localized disease. CONCLUSIONS: Continuous and deliberate efforts for multidisciplinary care in prostate cancer will be required to optimize and improve the oncologic and functional outcomes of patients treated with salvage therapies in the future.

Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part I: Introduction and Treatment Decision-Making at the Time of Suspected Biochemical Recurrence after Radical Prostatectomy.

PURPOSE: The summary presented herein covers recommendations on salvage therapy for recurrent prostate cancer intended to facilitate care decisions and aid clinicians in caring for patients who have experienced a recurrence following prior treatment with curative intent. This is Part I of a three-part series focusing on treatment decision-making at the time of suspected biochemical recurrence (BCR) after radical prostatectomy (RP). Please refer to Part II for discussion of treatment delivery for non-metastatic BCR after RP and Part III for discussion of evaluation and management of recurrence after radiotherapy (RT) and focal therapy, regional recurrence, and oligometastasis. MATERIALS AND METHODS: The systematic review that informs this Guideline was based on searches in Ovid MEDLINE (1946 to July 21, 2022), Cochrane Central Register of Controlled Trials (through August 2022), and Cochrane Database of Systematic Reviews (through August 2022). Update searches were conducted on July 26, 2023. Searches were supplemented by reviewing electronic database reference lists of relevant articles. RESULTS: In a collaborative effort between AUA, ASTRO, and SUO, the Salvage Therapy for Prostate Cancer Panel developed evidence- and consensus-based statements to provide guidance for the care of patients who experience BCR after initial definitive local therapy for clinically localized disease. CONCLUSIONS: Advancing work in the area of diagnostic tools (particularly imaging), biomarkers, radiation delivery, and biological manipulation with the evolving armamentarium of therapeutic agents will undoubtedly present new opportunities for patients to experience long-term control of their cancer while minimizing toxicity.

Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy.

PURPOSE: The summary presented herein covers recommendations on salvage therapy for recurrent prostate cancer intended to facilitate care decisions and aid clinicians in caring for patients who have experienced a recurrence following prior treatment with curative intent. This is Part II of a three-part series focusing on treatment delivery for non-metastatic biochemical recurrence (BCR) after primary radical prostatectomy (RP). Please refer to Part I for discussion of treatment decision-making and Part III for discussion of evaluation and management of recurrence after radiotherapy (RT) and focal therapy, regional recurrence, and oligometastasis. MATERIALS AND METHODS: The systematic review that informs this Guideline was based on searches in Ovid MEDLINE (1946 to July 21, 2022), Cochrane Central Register of Controlled Trials (through August 2022), and Cochrane Database of Systematic Reviews (through August 2022). Update searches were conducted on July 26, 2023. Searches were supplemented by reviewing electronic database reference lists of relevant articles. RESULTS: In a collaborative effort between AUA, ASTRO, and SUO, the Salvage Therapy for Prostate Cancer Panel developed evidence- and consensus-based guideline statements to provide guidance for the care of patients who experience BCR after initial definitive local therapy for clinically localized disease. CONCLUSIONS: Optimizing and personalizing the approach to salvage therapy remains an ongoing area of work in the field of genitourinary oncology and represents an area of research and clinical care that requires well-coordinated, multi-disciplinary efforts.

Preparing Trainees to Rebound from Surgical Complications.

PURPOSE OF REVIEW: In this review, we aim to summarize the impact of surgical complications and adverse events on surgeons, including psychiatric illnesses. We evaluate current programs to develop trainee well-being and investigate research within the field of urology. RECENT FINDINGS: Surgical complications and adverse events affect all surgeons, including surgical trainees. Research estimates that 80% of healthcare professionals have been involved in an event that affected them emotionally. These events can affect physicians in many ways, ranging from negatively impacting their quality of life to leading to psychiatric disorders such as acute stress reactions and post-traumatic stress disorder. Unfortunately, there is no standardized preparation to equip trainees to manage and rebound from the profound emotional impact of surgical complications. Data in this realm is insufficient, especially in urology, and we need more research in order to better evaluate emotional implications of complications on trainees and how we can prepare trainees to handle them.

Robotic Versus Open Cystectomy for Bladder Cancer: Synthesizing the Data from Current Systematic Reviews and Meta-Analyses.

This is a summary of existing systematic reviews comparing robotic assisted radical cystectomy (RARC) with open radical cystectomy (ORC). Our aim was to compare operative approaches with respect to perioperative, postoperative, oncologic, and health-related quality of life (QOL) outcomes. We performed a systematic review of MEDLINE, Medline-in-Process and Medline Epubs Ahead of Print, and the Cochrane Library on 22 February 2022. We included reviews of adult patients with bladder cancer undergoing RARC or ORC for muscle invasive or high-risk non-muscle invasive bladder cancer. Nonrandomized studies were excluded to minimize confounding and selection bias. The GRADE approach was used to determine the confidence in estimates. We assessed the quality of identified systematic reviews using AMSTAR 2 checklist. Six well-conducted, systematic reviews and meta-analyses were included. RARC was consistently associated with lower estimated blood loss (EBL) and transfusion rates, and longer operative time. There was inconsistent evidence for the impact of RARC on hospital length of stay (LOS). There was no significant difference in overall complication rate or major complication rate, or oncologic outcomes between groups. Comparison of QOL outcomes between studies was limited by statistical and methodological heterogeneity. RARC is associated with improvement in EBL and transfusion risk. There does not appear to be differences in oncologic outcomes or complications between approaches. Prospective studies are needed to assess the impact of diversion type, technique, and recovery pathways on patient outcomes and to assess the impact of operative approach on cost and patient-reported QOL.

Label-Free Enhancement of Adrenal Gland Visualization Using Near-Infrared Autofluorescence for Surgical Guidance.

BACKGROUND: During adrenalectomy, surgeons have traditionally relied on their subjective visual skills to distinguish adrenal glands (AGs) from retroperitoneal fat and surrounding structures, while ultrasound and exogenous contrast agents have been employed for intraoperative AG visualization, all of which have their limitations. We present a novel label-free approach that uses near-infrared autofluorescence (NIRAF) detection, which demonstrates potential for enhanced intraoperative AG visualization and efficient tumor resection during adrenalectomies. METHODS: Patients undergoing adrenalectomy or nephrectomy were enrolled for this feasibility study. NIRAF emitted beyond 800 nm was detected in vivo from AGs and surrounding tissues during open adrenalectomies or nephrectomies. NIRAF was also measured ex vivo in excised AGs following robotic adrenalectomies. NIRAF images of tissues were captured using near-infrared (NIR) camera systems, whereas NIRAF intensities were recorded concurrently using fiber-optic probe-based NIR devices. Normalized NIRAF intensities (expressed as mean ± standard error) were analyzed and compared. RESULTS: Among the 55 enrolled patients, NIRAF intensity was elevated significantly for AGs versus retroperitoneal fat and other structures. NIR images of AGs also revealed a distinct demarcation of NIRAF between adrenal cortex and other periadrenal structures. NIRAF intensity in AGs was decreased markedly in malignant adrenal tumors, while benign adrenal cortical tumors and healthy adrenal cortex exhibited the strongest NIRAF levels. CONCLUSIONS: Our preliminary findings indicate that NIRAF detection could be a promising label-free technology to enhance intraoperative AG visualization and holds immense potential for effective tumor demarcation during cortical-sparing adrenalectomies or adrenal-conserving surgeries.

Association Between Surgeon and Anesthesiologist Sex Discordance and Postoperative Outcomes: A Population-based Cohort Study.

OBJECTIVE: The aim of this study was to examine the effect of surgeon-anesthesiologist sex discordance on postoperative outcomes. SUMMARY BACKGROUND DATA: Optimal surgical outcomes depend on teamwork, with surgeons and anesthesiologists forming two key components. There are sex and sex-based differences in interpersonal communication and medical practice which may contribute to patients' perioperative outcomes. METHODS: We performed a population-based, retrospective cohort study among adult patients undergoing 1 of 25 common elective or emergent surgical procedures from 2007 to 2019 in Ontario, Canada. We assessed the association between differences in sex between surgeon and anesthesiologists (sex discordance) on the primary endpoint of adverse postoperative outcome, defined as death, readmission, or complication within 30 days following surgery using generalized estimating equations. RESULTS: Among 1,165,711 patients treated by 3006 surgeons and 1477 anesthesiologists, 791,819 patients were treated by sex concordant teams (male surgeon/male anesthesiologist: 747,327 and female surgeon/female anesthesiologist: 44,492), whereas 373,892 were sex discordant (male surgeon/female anesthesiologist: 267,330 and female surgeon/male anesthesiologist: 106,562). Overall, 12.3% of patients experienced >1 adverse postoperative outcomes of whom 1.3% died. Sex discordance between surgeon and anesthesiologist was not associated with a significant increased likelihood of composite adverse postoperative outcomes (adjusted odds ratio 1.00, 95% confidence interval 0.97-1.03). CONCLUSIONS: We did not demonstrate an association between intraoperative surgeon and anesthesiologist sex discordance on adverse postoperative outcomes in a large patient cohort. Patients, clinicians, and administrators may be reassured that physician sex discordance in operating room teams is unlikely to clinically meaningfully affect patient outcomes after surgery.

A Patient-Centered Approach to Research Prioritization in Prostate Cancer.

PURPOSE: Research priorities are often set by expert clinicians and researchers. We sought to apply an established process in patient-centered research to engage survivors and their caregivers in prioritizing research topics in prostate cancer. MATERIALS AND METHODS: A prostate cancer patient survey network, formed in partnership with Us TOO and the National Alliance of State Prostate Cancer Coalitions, engaged in a series of mixed-methods studies to prioritize comparative effectiveness research questions. This was accomplished through an iterative process that included 2 survey rounds and multidisciplinary working groups. RESULTS: There were 591 and 706 survey respondents in the first and second rounds, respectively, with most having had localized prostate cancer (58.1%). Survey participants represented 45 states in the U.S. Five of the top 11 prioritized research questions related to treatment decision making and/or survivorship care. The following had the highest overall importance ratings: What is the comparative effectiveness of different 1) strategies to improve counseling regarding the side effects of prostate cancer treatment, 2) tools for decision making in localized prostate cancer and 3) sequences of treatments for metastatic prostate cancer? CONCLUSIONS: We present a unique, patient-centered list of prioritized research questions among prostate cancer patients and their caregivers. These research questions may inform funding decisions for organizations that support research, and should be considered as priorities for clinicians, researchers and institutions conducting prostate cancer research. Prostate cancer is a common disease that affects 1 in 9 men over their lifetime. Researchers usually identify questions to study without asking men with prostate cancer. We asked survivors of prostate cancer and their caregivers to help us. They identified research questions and topics that are important to them. Researchers can focus on this list of questions to help men with prostate cancer. Groups who pay for research studies can make these questions their priority.

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

PURPOSE: We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years. MATERIALS AND METHODS: We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance. Regression models were adjusted for outcome-specific baseline function, demographic and clinicopathological characteristics, and treatment approach. RESULTS: A total of 2,742 men (median [quartiles] age 64 [59-70]) met inclusion criteria. Baseline depressive symptoms, as measured by the CES-D, were low (median 4, quartiles 1-8) without differences between groups. We found no effect of treatment modality on depressive symptoms (p=0.78), though older age, poorer health, being unmarried and baseline CES-D score were associated with declines in mental health. There was no clinically meaningful association between treatment modality and scores for either emotional well-being (p=0.81) or energy/fatigue (p=0.054). CONCLUSIONS: This prospective, population-based cohort study of men with localized prostate cancer showed no clinically important differences in mental health outcomes including depressive symptoms, emotional well-being, and energy/fatigue according to the treatment received (surgery, radiotherapy, or surveillance). However, we identified a number of characteristics associated with worse mental health outcomes including: older age, poorer health, being unmarried, and baseline CES-D score which may allow for early identification of patients most at risk of these outcomes following treatment.

Racial disparities in mortality for patients with prostate cancer after radical prostatectomy.

BACKGROUND: Although racial disparities in prostate cancer survival are well documented, the relative importance of contributing factors remains unclear. Few studies have examined the disparity between Whites and Hispanics or between Whites and Asian Americans and Pacific Islanders (AAPIs). METHODS: Using data from the National Cancer Database for 526,690 patients with prostate cancer who underwent radical prostatectomy between 2004 and 2014, this study systematically evaluated the impact of clinical characteristics and factors related to access to care on survival by race. Included in the analysis were 432,640 White patients (82.1%), 63,602 Black patients (12.1%), 8990 AAPI patients (1.7%), and 21,458 Hispanic patients (4.1%). Multivariable Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals to measure racial survival disparities. Inverse probability weighting was used to adjust for imbalances of prognostic factors. RESULTS: When adjustments were made for age and year of diagnosis only, Blacks had 51% higher mortality, AAPIs had 22% lower mortality, and Hispanics had 6% lower mortality than Whites. Overall, with adjustments for all clinical factors and nonclinical factors, the Black-White survival disparity narrowed to 20%, whereas the AAPI-White disparity increased to 35%. Among the controlled-for factors, education, median household income, and insurance status contributed the most to the racial disparity. CONCLUSIONS: The overall survival disparity among men undergoing radical prostatectomy was significantly decreased, but not eliminated, for Blacks and significantly increased for AAPIs in comparison with Whites after adjustments for a number of clinical factors and factors related to access to care.

Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study.

BACKGROUND: Ensuring representative data accrual in clinical trials is important to safeguard the generalizability of results and to minimize disparities in care. This study's goal was to evaluate differences in gender representation in trials leading to US Food and Drug Administration (FDA) cancer drug approvals. METHODS: An observational study was conducted from January 2014 to April 2019 using PubMed and the National Institutes of Health trials registry for primary trial reports. The National Cancer Institute's Surveillance, Epidemiology, and End Results program and US Census were consulted for national cancer incidence. The outcome was an enrollment incidence disparity (EID), which was calculated as the difference between male and female trial enrollment and national incidence, with positive values representing male overrepresentation. RESULTS: There were 149 clinical trials with 59,988 participants-60.3% and 39.7% were male and female, respectively-leading to 127 oncology drug approvals. The US incidence rates were 55.4% for men versus 44.6% for women. Gender representation varied by specific tumor type. Most notably, women were underrepresented in thyroid cancer (EID, +27.4%), whereas men were underrepresented in soft tissue cancer (EID, -26.1%). Overall, women were underrepresented when compared with expected incidence (EID, +4.9%; 42% of trials). CONCLUSIONS: For many specific tumor types, women are underrepresented in clinical trials leading to FDA oncology drug approvals. It is critical to better align clinical trial cohort demographics and the populations to which these data will be extrapolated. LAY SUMMARY: This study assesses whether gender disparities exist in clinical trials leading to US Food and Drug Administration (FDA) cancer drug approvals. From January 2014 to April 2019, 149 clinical trials leading to FDA oncology drug approvals showed 60.3% and 39.7% of the enrollees were male and female, respectively. Gender representation varied by specific tumor when compared with the expected incidence rate of cancer in the United States, although women were more often underrepresented. Increased efforts are needed with regard to ensuring equitable representation in oncology clinical trials.

Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States.

PURPOSE: Numerous treatment breakthroughs for patients with metastatic castration-resistant prostate cancer (mCRPC) have been demonstrated in clinical trials in the past 15 years. However, real-world evidence on the changing epidemiology and longevity of this population has not been demonstrated. This study assessed prevalence trends for mCRPC over eight years in a large managed care population. METHODS: In a claims database, adult male patients were included with ≥ 1 claim for prostate cancer, pharmacologic/surgical castration, and metastatic disease during the identification period. The index mCRPC date was the first metastatic claim; six months of continuous enrollment before and after was required. Patients with metastatic disease at baseline were excluded. Patients were followed until death, end of study, or disenrollment, whichever was earliest. Total, mCRPC per-prostate cancer, and age-specific prevalence rates were calculated cross-sectionally for each year under study (2010-2017). RESULTS: Of 343,089 patients identified with a claim for prostate cancer, 3690 mCRPC cases (1.1%) were identified. Incidence (new cases per year) remained relatively constant over the study period while prevalence of mCRPC (total cases per year) increased. mCRPC prevalence increased with increasing age. Total and mCRPC per-prostate cancer prevalence rates increased in monotonic, year-over-year trends from 2010 to 2017, while incidence (new cases per year) of mCRPC remained relatively stable. CONCLUSION: This study found increasing prevalence of mCRPC in an insured patient population during the 8-year period, coupled with stable incidence, validating that patients with the disease are living longer. With the addition of androgen receptor-directed therapies and poly(ADP-ribose) polymerase inhibitors in recent years, this trend will likely continue.

Association between cytoreductive nephrectomy and survival among patients with metastatic renal cell carcinoma receiving modern therapies: a systematic review and meta-analysis examining effect modification according to systemic therapy approach.

PURPOSE: Cytoreductive nephrectomy (CN) has played a role in treatment of metastatic renal cell carcinoma (mRCC) since trials demonstrated a survival benefit in patients receiving CN with interferon. With the publication of CARMENA, it became clear that the value of CN may depend on the co-therapy administered. We sought to assess the benefit of CN in the era of modern immunotherapy (IO). METHODS: We performed a systematic review to identify studies assessing CN in patients receiving TT or IO. We extracted multivariable-adjusted hazard ratios for the association between CN and overall survival (OS) and performed random effects meta-analysis. We tested for effect modification by systemic therapy approach on the association between CN and OS by pooling the difference in logHR associated with CN for patients treated with TT versus IO. RESULTS: We identified three comparisons assessing CN in patients receiving TT or IO. Pooled analysis indicated improved survival with CN in both the TT (2 cohorts, pooled HR: 0.52, 95% CI 0.46-0.59; I2 = 80%) and IO era (2 cohorts; pooled HR: 0.28, 95% CI 0.16-0.49; I2 = 21%), with a stronger association in the IO era (p = 0.01; I2 = 0%). CONCLUSION: In observational datasets, we observed a larger survival benefit to CN in patients treated with IO-based regimens versus those treated with TT-based regimens. While the role of CN for patients receiving TT has recently been questioned, this suggests that the results of CARMENA do not necessarily preclude a benefit to CN when combined with IO-based regimens.

Patient-Reported Financial Toxicity Associated with Contemporary Treatment for Localized Prostate Cancer.

PURPOSE: Contemporary treatment modalities for localized prostate cancer provide comparable overall and cancer-specific survival. However, the degree of financial burden imposed by treatment, the factors contributing to that burden, and how different treatments compare with regard to financial toxicity remain poorly understood. MATERIALS AND METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study enrolled men with localized prostate cancer from 2011 to 2012. Questionnaires were collected at 6, 12, 36, and 60 months after enrollment. Differences in patient-reported financial burden were compared between active surveillance, radical prostatectomy, and external beam radiotherapy using multivariable logistic regression. RESULTS: Among 2,121 patients meeting inclusion criteria, 15% reported large or very large burden of treatment costs within 6 months, declining to 3% by year 5. When controlling for age, education, income and other covariates, external beam radiotherapy was associated with greater financial burden than active surveillance and radical prostatectomy at 1 year (OR 2.2, 95% CI 1.2-4.1 and OR 1.5, 95% CI 1.0-2.3, respectively) and 3 years (OR 3.1 95% CI 1.1-8.8 and OR 2.1, 95% CI 1.2-3.7, respectively). Radical prostatectomy and active surveillance had similar rates of financial burden at all time points. Age, race, education, and D'Amico risk group were associated with financial burden. CONCLUSIONS: External beam radiotherapy was associated with the highest financial burden, even when controlling for age, education and income. Prospective studies that directly measure out-of-pocket and indirect costs and account more thoroughly for baseline socioeconomic differences are warranted in order to identify those most at risk.

Understanding the Costs Associated With Surgical Care Delivery in the Medicare Population.

BACKGROUND: Surgical care has been largely untargeted by Medicare payment reforms because episode costs associated with its delivery are not currently well understood. OBJECTIVE: To quantify the costs of inpatient and outpatient surgery in the Medicare population. METHODS: We analyzed claims data from a 20% national sample of Medicare beneficiaries (2008-2014). For a given study year, we identified all inpatient and outpatient procedures and constructed claims windows around them to define surgical episodes. After summing payments for services rendered during each episode, we totaled all inpatient and outpatient episode payments by surgical specialty. For inpatient episodes, we determined component payments related to the index hospitalization, readmissions, physician services, and postacute care. For outpatient episodes, we differentiated by the site of care (hospital outpatient department versus physician office versus ambulatory surgery center). We used linear regression to evaluate temporal trends in inpatient and outpatient surgical spending. Finally, we estimated the contribution of surgical care to overall Medicare expenditures. RESULTS: Total Medicare payments for surgical care are substantial, representing 51% of Program spending in 2014. They declined modestly over the study period, from $133.1 billion in 2008 to $124.9 billion in 2014 (-6.2%, P = 0.085 for the temporal trend). While spending on inpatient surgery contributed the most to total surgical payments (69.4% in 2014), it declined over the study period, driven by decreases in index hospitalization (-16.7%, P = 0.002) and readmissions payments (-27.0%, P = 0.003). In contrast, spending on outpatient surgery increased by $8.5 billion (28.7%, P < 0.001). This increase was realized across all sites of care (hospital outpatient department: 36.6%, P < 0.001; physician office: 22.1%, P < 0.001; ambulatory surgery center: 36.6%, P < 0.001). Ophthalmology and hand surgery witnessed the greatest growth in surgical spending over the study period. CONCLUSIONS AND RELEVANCE: Surgical care accounts for half of all Medicare spending. Our findings not only highlight the magnitude of spending on surgery, but also the areas of greatest growth, which could be targeted by future payment reforms.

Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer.

Importance: Understanding adverse effects of contemporary treatment approaches for men with favorable-risk and unfavorable-risk localized prostate cancer could inform treatment selection. Objective: To compare functional outcomes associated with prostate cancer treatments over 5 years after treatment. Design, Setting, and Participants: Prospective, population-based cohort study of 1386 men with favorable-risk (clinical stage cT1 to cT2bN0M0, prostate-specific antigen [PSA] ≤20 ng/mL, and Grade Group 1-2) prostate cancer and 619 men with unfavorable-risk (clinical stage cT2cN0M0, PSA of 20-50 ng/mL, or Grade Group 3-5) prostate cancer diagnosed in 2011 through 2012, accrued from 5 Surveillance, Epidemiology and End Results Program sites and a US prostate cancer registry, with surveys through September 2017. Exposures: Treatment with active surveillance (n = 363), nerve-sparing prostatectomy (n = 675), external beam radiation therapy (EBRT; n = 261), or low-dose-rate brachytherapy (n = 87) for men with favorable-risk disease and treatment with prostatectomy (n = 402) or EBRT with androgen deprivation therapy (n = 217) for men with unfavorable-risk disease. Main Outcomes and Measures: Patient-reported function, based on the 26-item Expanded Prostate Index Composite (range, 0-100), 5 years after treatment. Regression models were adjusted for baseline function and patient and tumor characteristics. Minimum clinically important difference was 10 to 12 for sexual function, 6 to 9 for urinary incontinence, 5 to 7 for urinary irritative symptoms, and 4 to 6 for bowel and hormonal function. Results: A total of 2005 men met inclusion criteria and completed the baseline and at least 1 postbaseline survey (median [interquartile range] age, 64 [59-70] years; 1529 of 1993 participants [77%] were non-Hispanic white). For men with favorable-risk prostate cancer, nerve-sparing prostatectomy was associated with worse urinary incontinence at 5 years (adjusted mean difference, -10.9 [95% CI, -14.2 to -7.6]) and sexual function at 3 years (adjusted mean difference, -15.2 [95% CI, -18.8 to -11.5]) compared with active surveillance. Low-dose-rate brachytherapy was associated with worse urinary irritative (adjusted mean difference, -7.0 [95% CI, -10.1 to -3.9]), sexual (adjusted mean difference, -10.1 [95% CI, -14.6 to -5.7]), and bowel (adjusted mean difference, -5.0 [95% CI, -7.6 to -2.4]) function at 1 year compared with active surveillance. EBRT was associated with urinary, sexual, and bowel function changes not clinically different from active surveillance at any time point through 5 years. For men with unfavorable-risk disease, EBRT with ADT was associated with lower hormonal function at 6 months (adjusted mean difference, -5.3 [95% CI, -8.2 to -2.4]) and bowel function at 1 year (adjusted mean difference, -4.1 [95% CI, -6.3 to -1.9]), but better sexual function at 5 years (adjusted mean difference, 12.5 [95% CI, 6.2-18.7]) and incontinence at each time point through 5 years (adjusted mean difference, 23.2 [95% CI, 17.7-28.7]), than prostatectomy. Conclusions and Relevance: In this cohort of men with localized prostate cancer, most functional differences associated with contemporary management options attenuated by 5 years. However, men undergoing prostatectomy reported clinically meaningful worse incontinence through 5 years compared with all other options, and men undergoing prostatectomy for unfavorable-risk disease reported worse sexual function at 5 years compared with men who underwent EBRT with ADT.

Early effect of Medicare Shared Savings Program accountable care organization participation on prostate cancer care.

BACKGROUND: Accountable care organizations (ACOs) can improve prostate cancer care by decreasing treatment variations (ie, avoidance of treatment in low-value settings). Herein, the authors performed a study to understand the effect of Medicare Shared Savings Program ACOs on prostate cancer care. METHODS: Using a 20% Medicare sample, the authors identified men with newly diagnosed prostate cancer from 2010 through 2013. Rates of treatment, potential overtreatment (ie, treatment in men with a ≥75% chance of 10-year mortality from competing risks), and Medicare payments were measured using regression models. The impact of ACO participation was assessed using difference-in-differences analyses. RESULTS: Before implementation of ACOs, the treatment rate was 71.8% (95% confidence interval [95% CI], 70.2%-73.3%) for ACO-aligned beneficiaries and 72.3% (95% CI, 71.7%-73.0% [P = .51]) for non-ACO-aligned beneficiaries. After implementation, this rate declined to 68.4% (95% CI, 66.1%-70.7% [P = .017]) for ACO-aligned beneficiaries and 69.3% (95% CI, 68.5%-70.1% [P<.001]) for non-ACO-aligned beneficiaries. There was no differential effect noted for ACO participation. The rate of potential overtreatment decreased from 48.2% (95% CI, 43.1%-53.3%) to 40.2% (95% CI, 32.4%-48.0% [P = .087]) for ACO-aligned beneficiaries and increased from 44.3% (95% CI, 42.1%-46.5%) to 47.0% (95% CI, 44.5%-49.5% [P = .11]) for non-ACO-aligned beneficiaries. These changes resulted in a significant relative decrease in overtreatment of 17% for ACO-aligned beneficiaries (difference-in-differences, 10.8%; P = .031). Payments were not found to be differentially affected by ACO alignment. CONCLUSIONS: The treatment of prostate cancer and annual payments decreased significantly between 2010 and 2013, but ACO participation did not appear to impact these trends. Among men least likely to benefit, Medicare Shared Savings Program ACO alignment was associated with a significant decline in prostate cancer treatment. Cancer 2018;124:563-70. © 2017 American Cancer Society.

Leveraging the clinical collaborative model to drive value improvement.

PURPOSE OF REVIEW: Physician-led quality improvement collaboratives have emerged across surgical disciplines as a means to measure and subsequently improve the quality and cost of care. In this review, we will provide an overview of recent successes within quality improvement collaboratives, as well as discuss future opportunities for such initiatives. RECENT FINDINGS: Successful quality improvement collaboratives have coupled data registries with a collegial environment to achieve data-driven improvements in care across diverse practice settings. Such efforts have a track record for accomplishing specific patient safety gains, and have more recently addressed complex care scenarios where data and consensus building have been leveraged to clarify optimal care pathways. Collaboratives are currently exploring mechanisms to meaningfully impact increasingly complex elements of care delivery, such as individual surgeon performance. SUMMARY: Quality improvement collaboratives are in a unique position to understand patterns in care across populations, lead evidence-based assessments of variation in quality, and to attempt to intervene to improve outcomes based on the data they accumulate. As healthcare increasingly shifts to emphasize quality of care, physician-led collaboratives represent an important mechanism to drive improvement.