Impact of Subsequent Biopsies on Comprehensive Health Related Quality of Life in Patients with and without Prostate Cancer.

PURPOSE: The aim of this study was to identify the effects of subsequent prostate needle biopsies after the baseline biopsy on health related quality of life with time. We compared men with and without prostate cancer, and men who did and did not undergo followup prostate needle biopsy. MATERIALS AND METHODS: Included in analysis were patients enrolled in the Center for Prostate Disease Research Multicenter National Database between 2007 and 2015 who had low or favorable intermediate risk prostate cancer, were on active surveillance and underwent prostate needle biopsy for suspicion of prostate cancer. Patients completed the EPIC (Expanded Prostate Cancer Index Composite) and the RAND SF-36 (36-Item Short Form Health Survey) after baseline biopsy and at regular followup intervals. Mean health related quality of life was compared with time between patients who did and did not undergo subsequent prostate needle biopsies following baseline. RESULTS: Of the 637 patients included in study 129 (20.3%) with prostate cancer were on active surveillance and 508 (79.7%) were in the noncancer group. In the cancer and noncancer groups mean ± SD followup was 34.7 ± 16.9 and 31.6 ± 14.6 months, respectively. Of the patients with prostate cancer 54 (60.7%) underwent subsequent prostate needle biopsies compared with 114 (27.1%) without cancer. No significant impact on health related quality of life was observed in men who underwent subsequent prostate needle biopsies during a 5-year period. CONCLUSIONS: A subsequent prostate needle biopsy is required in most active surveillance protocols and in men with persistent suspicion of prostate cancer. Our analysis shows that subsequent prostate needle biopsies do not significantly impact health related quality of life.

A prospective study of health-related quality of life outcomes among men treated for intermediate- and high-risk prostate cancer: the impact of primary and secondary therapies.

INTRODUCTION: To assess the impact of primary and secondary therapies for high- and intermediate-risk prostate cancer on health-related quality of life (HRQoL). MATERIALS AND METHODS: A prospective study was initiated in 2007 at Center for Prostate Disease Research Multicenter National Database sites. Longitudinal patterns in HRQoL from baseline (pre-treatment) to 5 years post-diagnosis were examined for patients with high- and intermediate-risk prostate cancer, treated by radical prostatectomy (RP) or external beam radiation therapy (EBRT). Change in HRQoL was modeled using linear regression models fit with generalized estimating equations. The probability of maintaining HRQoL was compared between patients receiving RP only versus RP with secondary treatment. RESULTS: Of 445 men with high- and intermediate-risk prostate cancer, 228 underwent RP and 143 had EBRT± androgen deprivation therapy (ADT). Fifty received secondary therapy (EBRT and/or ADT or chemotherapy) after RP. RP patients showed a greater decline over time in sexual function and bother and urinary function compared to EBRT±ADT patients. Patients who had secondary therapy after RP were less likely to maintain their HRQoL compared to those who had RP alone. These differences were most pronounced for sexual and hormonal function. CONCLUSIONS: Prostate cancer patients experience significant declines in HRQoL after primary therapy. Additional secondary therapy after RP, in the form of EBRT and/or ADT, appears to be responsible for further deterioration in HRQoL outcomes.

Longitudinal regret after treatment for low- and intermediate-risk prostate cancer.

BACKGROUND: Prostate cancer patients diagnosed with low- and intermediate-risk disease have several treatment options. Decisional regret after treatment is a concern, especially when poor oncologic outcomes or declines in health-related quality of life (HRQoL) occur. This study assessed determinants of longitudinal decisional regret in prostate cancer patients attending a multidisciplinary clinic and treated with radical prostatectomy (RP), external beam radiation therapy (EBRT), brachytherapy (BT), or active surveillance (AS). METHODS: Patients newly diagnosed with prostate cancer at the Walter Reed National Military Medical Center who attended a multidisciplinary clinic were enrolled into a prospective study from 2006 to 2014. The Decision Regret Scale was administered at 6, 12, 24, and 36 months posttreatment. HRQoL was also assessed at regular intervals using the Expanded Prostate Cancer Index Composite and 36-item RAND Medical Outcomes Study Short Form questionnaires. Adjusted probabilities of reporting regret were estimated via multivariable logistic regression fitted with generalized estimating equations. RESULTS: A total of 652 patients met the inclusion criteria (395 RP, 141 EBRT, 41 BT, 75 AS). Decisional regret was consistently low after all of these treatments. In multivariable models, only African American race (odds ratio, 1.67; 95% confidence interval, 1.12-2.47) was associated with greater regret across time. Age and control preference were marginally associated with regret. Regret scores were similar between RP patients who did and did not experience biochemical recurrence. Declines in HRQoL were weakly correlated with greater decisional regret. CONCLUSION: In the context of a multidisciplinary clinic, decisional regret did not differ significantly between treatment groups but was greater in African Americans and those reporting poorer HRQoL. Cancer 2017;123:4252-4258. © 2017 American Cancer Society.

Patterns of Care and Survival Outcomes for Malignant Sex Cord Stromal Testicular Cancer: Results from the National Cancer Data Base.

PURPOSE: Sex cord stromal tumors of the testis comprise less than 5% of testicular neoplasms. Consequently, data regarding patterns of care and survival are sparse. Using a large national database, we sought to provide a more definitive analysis of outcomes and management of these malignancies. MATERIALS AND METHODS: Data were obtained from the National Cancer Data Base. Patients diagnosed from 1998 to 2011 with 2 of the most frequent sex cord stromal tumors of the testis, including Leydig and Sertoli cell tumors, were selected for study. Overall survival estimates were assessed by the Kaplan-Meier method. RESULTS: Of the 79,120 cases of testicular cancer between 1998 and 2011, 315 (0.39%) were primary malignant Leydig or Sertoli cell tumors. Median patient age was 43 years for both tumors. Of the 315 patients 250 (79%) had malignant Leydig cell tumors and 65 (21%) had malignant Sertoli cell tumors, of which 94% and 78%, respectively, were stage I. Overall survival at 1 and 5 years for stage I Leydig cell tumors was 98% (95% CI 96-100) and 91% (95% CI 85-96), and for stage I Sertoli cell tumors overall survival was 93% (95% CI 83-100) and 77% (95% CI 62-95), respectively (p = 0.015). Of patients with stage I Leydig and Sertoli cell tumors 94% and 84%, respectively, received no further treatment following orchiectomy. CONCLUSIONS: Five-year survival estimates of stage I Leydig and Sertoli cell tumors are significantly lower compared to those of stage I germ cell tumors with Sertoli cell tumors significantly worse than Leydig cell tumors. These differences in the survival of sex cord stromal tumors indicate the importance of large databases to evaluate the efficacy of treatment for rare neoplasms.

Prostate Needle Biopsy Outcomes in the Era of the U.S. Preventive Services Task Force Recommendation against Prostate Specific Antigen Based Screening.

PURPOSE: We determined whether the characteristics of patients undergoing prostate needle biopsies and prostate needle biopsy results changed after the U.S. Preventive Services Task Force recommendation in 2012 against prostate specific antigen based screening for prostate cancer for men of any age. MATERIALS AND METHODS: A prospective database of patients undergoing prostate needle biopsies at Virginia Mason from 2004 to 2014 was reviewed. Welch's t-test and chi-square tests were used to compare patients seen before to those seen after the USPSTF recommendation. Relative risks and corresponding confidence intervals were estimated by general linear regression. RESULTS: Patients in the post-USPSTF group (310) had a higher prostate specific antigen (p <0.001), were more likely to be diagnosed with higher clinical stage (2b, p=0.003; 2c-3a, p=0.027) and D'Amico high risk prostate cancer (p=0.036), with an adjusted relative risk for high risk prostate cancer of 1.25 (95% CI 1.02-1.52) compared to those in the pre-USPSTF group (1,416). Limiting the pre-USPSTF group to the 30 months before the draft guidelines (448 patients) yielded similar results. The absolute number of biopsies performed decreased by 31%, with the majority of the decrease occurring in the detection of intermediate risk tumors. CONCLUSIONS: In the 2 and a half years after the USPSTF recommendation against prostate specific antigen based screening, patients undergoing prostate needle biopsies were significantly more likely to be diagnosed with high risk disease. However, a reduction in the number of prostate needle biopsies performed occurred concomitantly with a decrease in the detection of intermediate risk, potentially curable prostate cancer. Future focus on informed application of screening techniques may prevent the reversal of decades of improvement in the prostate cancer mortality rate.

Prospective Quality of Life in Men Choosing Active Surveillance Compared to Those Biopsied but not Diagnosed with Prostate Cancer.

PURPOSE: Active surveillance is an important alternative to definitive therapy for men with low risk prostate cancer. However, the impact of active surveillance on health related quality of life compared to that in men without cancer remains unknown. In this study we evaluated health related quality of life outcomes in men on active surveillance compared to men followed after negative prostate needle biopsy. MATERIALS AND METHODS: A prospective study was conducted on men who were enrolled into the Center for Prostate Disease Research Multicenter National Database and underwent prostate needle biopsy for suspicion of prostate cancer between 2007 and 2014. Health related quality of life was assessed at biopsy (baseline) and annually for up to 3 years using SF-36 and EPIC questionnaires. Health related quality of life scores were modeled using generalized estimating equations, adjusting for baseline health related quality of life, and demographic and clinical characteristics. RESULTS: Of the 1,204 men who met the initial eligibility criteria 420 had a negative prostate needle biopsy (noncancer comparison group). Among the 411 men diagnosed with low risk prostate cancer 89 were on active surveillance. Longitudinal analysis revealed that for most health related quality of life subscales there were no significant differences between the groups in adjusted health related quality of life score trends over time. CONCLUSIONS: In this study most health related quality of life outcomes in patients with low risk prostate cancer on active surveillance did not differ significantly from those of men without prostate cancer. A comparison group of men with a similar risk of prostate cancer detection is critical to clarify the psychological and physical impact of active surveillance.

Prospective quality-of-life outcomes for low-risk prostate cancer: Active surveillance versus radical prostatectomy.

BACKGROUND: For patients with low-risk prostate cancer (PCa), active surveillance (AS) may produce oncologic outcomes comparable to those achieved with radical prostatectomy (RP). Health-related quality-of-life (HRQoL) outcomes are important to consider, yet few studies have examined HRQoL among patients with PCa who were managed with AS. In this study, the authors compared longitudinal HRQoL in a prospective, racially diverse, and contemporary cohort of patients who underwent RP or AS for low-risk PCa. METHODS: Beginning in 2007, HRQoL data from validated questionnaires (the Expanded Prostate Cancer Index Composite and the 36-item RAND Medical Outcomes Study short-form survey) were collected by the Center for Prostate Disease Research in a multicenter national database. Patients aged ≤75 years who were diagnosed with low-risk PCa and elected RP or AS for initial disease management were followed for 3 years. Mean scores were estimated using generalized estimating equations adjusting for baseline HRQoL, demographic characteristics, and clinical patient characteristics. RESULTS: Of the patients with low-risk PCa, 228 underwent RP, and 77 underwent AS. Multivariable analysis revealed that patients in the RP group had significantly worse sexual function, sexual bother, and urinary function at all time points compared with patients in the AS group. Differences in mental health between groups were below the threshold for clinical significance at 1 year. CONCLUSIONS: In this study, no differences in mental health outcomes were observed, but urinary and sexual HRQoL were worse for patients who underwent RP compared with those who underwent AS for up to 3 years. These data offer support for the management of low-risk PCa with AS as a means for postponing the morbidity associated with RP without concomitant declines in mental health.

Transperineal Template Guided Prostate Biopsy Selects Candidates for Active Surveillance--How Many Cores are Enough?

PURPOSE: Most prostate cancer active surveillance protocols recommend a confirmatory biopsy within 3 to 6 months of diagnosis. Transperineal template guided biopsy is an approach to improve the detection of high grade prostate cancer. However, to our knowledge the optimal technique is unknown. We evaluated the relative performance of 2 transperineal template guided biopsy approaches. MATERIALS AND METHODS: Institutional review board approved prospective databases at Virginia Mason and University of Michigan were used. Men eligible for active surveillance based on initial 12-core biopsy demonstrating NCCN® guideline low risk prostate cancer were included in study. All men underwent confirmatory transperineal template guided biopsy between 2005 and 2014, and within 6 months of diagnosis. The biopsy technique was based on a 24-core template with 12 anterior and 12 posterior cores or a template based on gland volume with an average of 1 core per cc. Outcome comparisons were made by the chi-square and Fisher exact tests, the Welch t-test and linear regression. RESULTS: Of the 135 men 46 underwent 24-core biopsy and 89 underwent volume based biopsy (median 62 cores). No statistically significant difference was noted in the prevalence of upgrading (35% vs 29%, p = 0.64) or complications (9% vs 16%, p = 0.38) between the 24-core and volume based groups. The difference in the probability of upgrading by volume based biopsy adjusted for age, prostate specific antigen, prostate volume, clinical stage and number of prior biopsies was -4% (95% CI -24 to 14%, p = 0.63). CONCLUSIONS: A significant difference was not detected in upgrading or morbidity between a 24-core template and a more exhaustive volume based template. A less invasive 24-core transperineal template guided biopsy strategy may suffice to accurately identify men who are appropriate for active surveillance.

Prognostic value of ERG oncoprotein in prostate cancer recurrence and cause-specific mortality.

BACKGROUND: ETS-related gene (ERG) protein is present in 40-70% of prostate cancer and is correlated with TMPRSS2-ERG gene rearrangements. This study evaluated ERG expression at radical prostatectomy to determine whether it was predictive of earlier relapse or prostate cancer-specific mortality (PCSM). METHODS: One hundred patients who underwent radical prostatectomy at Virginia Mason in Seattle between 1991 and 1997 were identified. Recurrence was confirmed by tissue diagnosis or radiographic signs. PCSM was confirmed by death certificates. Thirty-three patients with metastases or PCSM were matched to patients without recurrence at a 1:2 ratio. Paraffin embedded tissue was stained with two anti-ERG monoclonal antibodies, EPR3864 and 9FY. Nuclear expression intensity was evaluated as present/absent, on a 4-point relative intensity scale, and as a composite score (0-300). RESULTS: Mean follow-up was 10.26 years. The two antibodies were highly correlated (P < 0.0001). Patients with higher ERG expression intensity and composite scores were significantly more likely to develop biochemical relapse, metastases, and PCSM. Kaplan-Meier survival curve analysis for the composite score of ERG expression revealed a significant association between higher ERG expression (EPR3864) and shorter PCa-specific survival (P = 0.047). CONCLUSIONS: While the presence of ERG expression at the time of surgery was not predictive of earlier relapse or PCSM, the relative intensity and composite score for ERG expression was prognostic for the development of biochemical relapse, metastases, and PCSM. Quantitative ERG scoring may be useful to identify patients who would benefit from adjuvant treatment or closer follow-up, allowing more accurate individual patient treatment plans.

The association between pre-operative PSA and prostate cancer-specific mortality in patients with long-term follow-up after radical prostatectomy.

BACKGROUND: The clinical and pathologic predictors of prostate cancer-specific mortality (PCSM) many years after radical prostatectomy (RP) remain to be fully elucidated. We explored the association between pre-operative prostate-specific antigen (PSA) and other pathologic predictors and PCSM in men who have undergone (RP). METHODS: We report on 459 patients with PCSM data after RP who were followed prospectively over a 23-year period between 1987 and 1997. Cox regression and Kaplan-Meier analysis were used to evaluate pre-operative PSA, pathologic Gleason sum, pathologic stage, and surgical margin status as predictors of PCSM. RESULTS: The median PSA was 6.6 ng/ml (± 9.9) and the median follow-up time was 9.4 (± 4.9) years. Fourteen patients (3.1%) died of PC. On multivariate analysis, only PSA (HR: 1.050; P = 0.001) and binary Gleason sum (HR: 3.402; P = 0.043) remained significant predictors of PCSM. The predicted 10-year PCSM was significantly worse in those patients in the highest PSA tertile compared to those in other tertiles [PSA > 9.9: 87% (82-92%) vs. PSA = 4-9.9: 95% (93.0-97.0%) vs. PSA = 0-3.9: 100.0% (100.0-100.0%)]. CONCLUSIONS: We have highlighted the importance of pre-operative PSA in predicting PCSM many years after RP. It is a more significant predictor than Gleason sum and pathologic stage. Thus, PSA may help identify patients with life-threatening PC at a time when their disease is curable with definitive therapy.

Incidence of second malignancies after external beam radiotherapy for clinical stage I testicular seminoma.

OBJECTIVES: • To determine the use of adjuvant external beam radiotherapy (EBRT) for patients with clinical stage I testicular seminoma in the USA. • To quantify the risk of specific second primary malignancies (SPMs) associated with radiation exposure in these patients. PATIENTS AND METHODS: • We used the Surveillance, Epidemiology and End Results database to identify patients diagnosed with clinical stage I testicular seminoma between 1973 and 2000. • We evaluated the use of EBRT in these patients. • We calculated standardized incidence ratios of specific SPMs in these patients. • We stratified the incidence of SPMs based on age at seminoma diagnosis and time to SPM from initial seminoma diagnosis. RESULTS: • Adjuvant EBRT use declined from the first decade of the study period to the last decade of the study period (80.6% vs 70.2%). • Overall, there was a 19% increase in SPMs in patients exposed to EBRT (observed/expected, O/E, 1.51; 95% CI, 1.08-1.31) compared to the general population. • Specifically, significantly increased risks were observed for thyroid cancer (O/E, 2.32; 95% CI, 1.16-4.16), pancreatic cancer (O/E, 2.38; 95% CI, 1.43-3.72), non-bladder urothelial malignancies (O/E, 4.27; 95% CI, 1.57-9.29), bladder cancer (O/E, 1.47; 95% CI, 1.01-2.28), all haematological malignancies (O/E, 1.44; 95% CI, 1.08-1.89) and non-Hodgkin's lymphoma (O/E, 1.77; 95% CI, 1.22-2.48). • Patients had a persistently elevated risk of SPMs 15 years from the time of initial clinical stage I testicular seminoma diagnosis (O/E, 1.29; 95% CI, 1.10-1.49). CONCLUSIONS: • We confirmed the increased risk of SPMs after EBRT for seminoma, and we identified the specific types of SPMs that develop. • The risk of EBRT-associated SPM persists for years after the initial seminoma diagnosis, and patients should be informed about these long-term risks.

Opioid-Limiting Pain Control After Transurethral Resection of the Prostate: A Randomized Controlled Trial.

OBJECTIVE: To assess whether a multimodal opioid-limiting protocol and patient education intervention can reduce postoperative opioid use following transurethral resection of the prostate. METHODS: This prospective, non-blinded, single-institution, randomized controlled trial (NCT04102566) assigned 50 patients undergoing a transurethral resection of the prostate to either a standard of care control (SOC) or multimodal experimental group (MMG). The intervention included adding ibuprofen to the postoperative pain regimen, promoting appropriate opioid use while hospitalized, an educational intervention, and discharging without opioid prescription. Data regarding demographics, operative data, opioid use, pain scores, and patient satisfaction were compared. RESULTS: A total of 47 patients were included, n = 23 (MMG) and n = 24 (SOC). Demographic and operative findings were similar. Statistical analysis for noninferiority demonstrated non-inferior inpatient pain control (mean pain score 2.5 MMG vs 2.4 SOC, P = 0.0003). The multimodal group used significantly fewer morphine milligram equivalents after discharge (0 vs 4.1, P = 0.04). Inpatient use was reduced but did not reach statistical significance (6.0 vs 9.8, P = 0.2). Mean satisfaction scores with pain control were similar (9.6 MMG vs 9.2 SOC, P = 0.32). No opioid prescriptions were requested after discharge. Adverse events and medication side effects were infrequent and largely similar between groups. CONCLUSION: Implementation of an opioid-limiting postoperative pain protocol and patient education resulted in no outpatient opioid use while maintaining patient satisfaction with pain control. Eliminating opioids following a common urologic procedure will decrease risk of opioid-related adverse events and have a positive downstream impact.

Race-specific prostate cancer outcomes in a cohort of low and favorable-intermediate risk patients who underwent external beam radiation therapy from 1990 to 2017.

BACKGROUND: Previous research exploring the role of race on prostate cancer (PCa) outcomes has demonstrated greater rates of disease progression and poorer overall survival for African American (AA) compared to Caucasian American (CA) men. The current study examines self-reported race as a predictor of long-term PCa outcomes in patients with low and favorable-intermediate risk disease treated with external beam radiation therapy (EBRT). METHODS: This retrospective cohort study examined patients who were consented to enrollment in the Center for Prostate Disease Research Multicenter National Database between January 01, 1990 and December 31, 2017. Men self-reporting as AA or CA who underwent EBRT for newly diagnosed National Comprehensive Cancer Network-defined low or favorable-intermediate risk PCa were included. Dependent study outcomes included: biochemical recurrence-free survival, (ii) distant metastasis-free survival, and (iii) overall survival. Each outcome was modeled as a time-to-event endpoint using race-stratified Kaplan-Meier estimation curves and multivariable Cox proportional hazards analysis. RESULTS: Of 840 men included in this study, 268 (32%) were AA and 572 (68%) were CA. The frequency of biochemical recurrence, distant metastasis, and deaths from any cause was 151 (18.7%), 29 (3.5%), and 333 (39.6%), respectively. AA men had a significantly younger median age at time of EBRT and slightly higher biopsy Gleason scores. Multivariable Cox proportional hazards analyses demonstrated no racial differences in any of the study endpoints. CONCLUSIONS: These findings reveal no racial disparity in PCa outcomes for AA compared to CA men, in a long-standing, longitudinal cohort of patients with comparable access to cancer care.

Contemporary trends in management of stage 1 seminoma.

PURPOSE: Surveillance is now the preferred treatment strategy for patients with stage 1A/1B seminoma as reflected by the National Comprehensive Cancer Network guidelines. In this study, we aimed to describe trends in adjuvant management strategy for stage 1A/B seminoma from 2004 to 2016 using the National Cancer Database. MATERIALS AND METHODS: The database was queried for patients diagnosed with stage 1A/1B seminoma between 2004 and 2016. Staging was determined using the American Joint Committee on Cancer guidelines. Surveillance was defined as no treatment with chemotherapy or radiation within 60 days of diagnosis. Proportions of cancer patients utilizing surveillance, radiation, and single-agent chemotherapy were summarized annually. Kaplan-Meier survival analysis was used to compare overall survival between groups. RESULTS: 8,686 patients with stage 1A/1B seminoma met inclusion criteria over the course of the study period. Overall, 3,004 (34.6%) patients began adjuvant chemotherapy or radiation within 60 days. Utilization of surveillance increased from 39.8% in 2004 to 86.8% in 2016 while utilization of radiation decreased from 59.7% to 4.6%. High-volume centers adopted surveillance earlier than low-volume centers. CONCLUSION: This study describes trends in utilization of surveillance, chemotherapy, and radiotherapy for stage 1A/1B seminoma over 12 years. A major shift from utilization of adjuvant treatment to surveillance in patients with stage 1A/B seminoma is observed in this large national cancer database; a minority of patients now receive adjuvant treatment and risk-related toxicities. Survival analysis reveals similar survival at a median 5-year follow-up. The results provide insight into the time needed for clinical practice to adopt the preferred approach of surveillance over the time period studied.

Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study.

INTRODUCTION: Robotic assisted laparoscopic radical prostatectomy (RALP) is a common treatment for localized prostate cancer. Despite a primary advantage of improved postoperative pain, patients undergoing RALP still experience discomfort. Belladonna, containing the muscarinic receptor antagonists atropine and scopolamine, in combination with opium as a rectal suppository (B & O) may improve post-RALP pain. This study evaluates whether a single preoperative B & O results in decreased postoperative patient-reported pain and analgesic requirements. MATERIALS AND METHODS: Patients undergoing RALP at Virginia Mason Medical Center between November 2008 and July 2009 were offered the opportunity to enter a randomized, double-blind, placebo-controlled trial. Exclusion criteria included: glaucoma, bronchial asthma, convulsive disorders, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency. Surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Postoperative pain was assessed by a visual analog scale (VAS) and postoperative narcotic use was calculated in intravenous morphine equivalents. RESULTS: Ninety-nine patients were included in the analysis. The B & O and control groups were not significantly different in terms of age, body mass index, operative time, nerve sparing status or prostatic volume. Postoperative pain was significantly improved during the first two postoperative hours in the B & O group. Similarly, 24-hour morphine consumption was significantly lower in patients who received a B & O. No adverse effects secondary to suppository placement were identified. CONCLUSION: Preoperative administration of B & O suppository results in significantly decreased postoperative pain and 24-hour morphine consumption in patients undergoing RALP.

A nomogram predicting prostate cancer-specific mortality after radical prostatectomy.

OBJECTIVE: We describe a model capable of predicting prostate cancer (PCa)-specific mortality up to 20 years after a radical prostatectomy (RP), which can adjust the predictions according to disease-free interval. PATIENTS AND METHODS: 752 patients were treated with RP for organ-confined PCa. Cox regression modeled the probability of PCa-specific mortality. The significance of the predictors was confirmed in competing risks analyses, which account for other-cause mortality. RESULTS: The mean follow-up was 11.4 years. The 5-, 10-, 15- and 20-year actuarial rates of PCa-specific survival were 99.0, 95.5, 90.9 and 85.7%, respectively. RP Gleason sum (p < 0.001), pT stage (p = 0.007), adjuvant radiotherapy (p = 0.03) and age at RP (p = 0.004) represented independent predictors of PCa-specific mortality in the Cox regression model as well as in competing risks regression. Those variables, along with lymph node dissection status (p = 0.4), constituted the nomogram predictors. After 200 bootstrap resamples, the nomogram achieved 82.6, 83.8, 75.0 and 76.3% accuracy in predicting PCa-specific mortality at 5, 10, 15 and 20 years post-RP, respectively. CONCLUSIONS: At 20 years, roughly 20% of men treated with RP may succumb to PCa. The current nomogram helps to identify these individuals. Their follow-up or secondary therapies may be adjusted according to nomogram predictions.

A prospective analysis of health-related quality of life in intermediate and high-risk prostate cancer patients managed with intensity modulated radiation therapy, with vs. without hormonal therapy.

INTRODUCTION: Combined radiotherapy and hormonal treatment are recommended for intermediate- and high-risk prostate cancer (CaP). This study compared the long-term effects on health-related quality of life (HRQoL) of intermediate- and high-risk CaP patients managed with radiation therapy (RT) with vs. without hormone therapy (HT). METHODS: Patients with intermediate- and high-risk CaP enrolled in the Center for Prostate Disease Research diagnosed from 2007 to 2017 were included. EPIC and SF-36 questionnaires were completed and HRQoL scores were compared for patients receiving RT vs. RT + HT at baseline (pretreatment), 6, 12, 24, 36, 48, and 60 months after CaP diagnosis. Longitudinal patterns of change in HRQoL were modeled using linear regression models, adjusting for baseline HRQoL, age at CaP diagnosis, race, comorbidities, National Comprehensive Cancer Network (NCCN) risk stratum, time to treatment, and follow-up time. RESULTS: Of 164 patients, 93 (56.7%) received RT alone and 71 (43.3%) received RT + HT. Both groups reported comparable baseline HRQoL. Patients receiving RT+HT were more likely to be NCCN high risk as compared to those receiving only RT. The RT + HT patients experienced worse sexual function, hormonal function, and hormonal bother than those who only received RT; however, HRQoL recovered over time for the RT + HT group. No significant differences were observed between groups in urinary and bowel domains or SF-36 mental and physical scores. CONCLUSION: Combined RT + HT treatment was associated with temporary lower scores in sexual and hormonal HRQoL compared with RT only. Intermediate- and high-risk CaP patients should be counseled about the possible declines in HRQoL associated with HT.

Optimum Imaging Strategies for Advanced Prostate Cancer: ASCO Guideline.

PURPOSE: Provide evidence- and expert-based recommendations for optimal use of imaging in advanced prostate cancer. Due to increases in research and utilization of novel imaging for advanced prostate cancer, this guideline is intended to outline techniques available and provide recommendations on appropriate use of imaging for specified patient subgroups. METHODS: An Expert Panel was convened with members from ASCO and the Society of Abdominal Radiology, American College of Radiology, Society of Nuclear Medicine and Molecular Imaging, American Urological Association, American Society for Radiation Oncology, and Society of Urologic Oncology to conduct a systematic review of the literature and develop an evidence-based guideline on the optimal use of imaging for advanced prostate cancer. Representative index cases of various prostate cancer disease states are presented, including suspected high-risk disease, newly diagnosed treatment-naïve metastatic disease, suspected recurrent disease after local treatment, and progressive disease while undergoing systemic treatment. A systematic review of the literature from 2013 to August 2018 identified fully published English-language systematic reviews with or without meta-analyses, reports of rigorously conducted phase III randomized controlled trials that compared ≥ 2 imaging modalities, and noncomparative studies that reported on the efficacy of a single imaging modality. RESULTS: A total of 35 studies met inclusion criteria and form the evidence base, including 17 systematic reviews with or without meta-analysis and 18 primary research articles. RECOMMENDATIONS: One or more of these imaging modalities should be used for patients with advanced prostate cancer: conventional imaging (defined as computed tomography [CT], bone scan, and/or prostate magnetic resonance imaging [MRI]) and/or next-generation imaging (NGI), positron emission tomography [PET], PET/CT, PET/MRI, or whole-body MRI) according to the clinical scenario.

Adjuvant radiotherapy after radical prostatectomy shows no ability to improve rates of overall and cancer-specific survival in a matched case-control study.

OBJECTIVE: To assess the effect of adjuvant radiotherapy (aRT) on the rate of cancer-specific and overall survival after radical prostatectomy (RP) in a group of patients with a long-term follow-up, as there is controversy about the benefit of aRT after RP for prostate cancer when endpoints beyond biochemical and local recurrence are considered. PATIENTS AND METHODS: Within a study cohort of 752 patients treated with RP, 118 (15.7%) received aRT; these patients were matched with controls who did not receive aRT after RP. Exact matches were made for pT stage, RP Gleason sum, surgical margin status, age (+/-10 years), year of surgery (+/-10 years) and delivery of hormonal therapy. Kaplan-Meier and life-table analyses were used to assess overall and cancer-specific survival RESULTS: The median (range) follow-up was 11.4 (0.1-41) years. The 10- and 20-year overall survival after RP in those with no aRT were, respectively, 81.1% and 44.8%, vs 75.5% and 40.0% in the aRT group (P = 0.1). The corresponding probabilities for cause-specific survival were, respectively, 97.3% and 89.0% vs 86.3% and 69.3% (P < 0.001). There was no statistically significant difference in the overall and cause-specific survival between the groups after matching (hazard ratio 0.9, log rank P = 0.6; and 2.1, log rank P = 0.1, respectively). CONCLUSIONS: Our analysis showed that, in a matched case-control study, aRT has no effect on overall and cancer-specific survival. Further randomized long-term studies are necessary to confirm these results.