PURPOSE Germline testing (GT) is a central feature of prostate cancer (PCA) treatment, management, and hereditary cancer assessment. Critical needs include optimized multigene testing strategies that incorporate evolving genetic data, consistency in GT indications and management, and alternate genetic evaluation models that address the rising demand for genetic services. METHODS A multidisciplinary consensus conference that included experts, stakeholders, and national organization leaders was convened in response to current practice challenges and to develop a genetic implementation framework. Evidence review informed questions using the modified Delphi model. The final framework included criteria with strong (> 75%) agreement (Recommend) or moderate (50% to 74%) agreement (Consider). RESULTS Large germline panels and somatic testing were recommended for metastatic PCA. Reflex testing—initial testing of priority genes followed by expanded testing—was suggested for multiple scenarios. Metastatic disease or family history suggestive of hereditary PCA was recommended for GT. Additional family history and pathologic criteria garnered moderate consensus. Priority genes to test for metastatic disease treatment included BRCA2, BRCA1, and mismatch repair genes, with broader testing, such as ATM, for clinical trial eligibility. BRCA2 was recommended for active surveillance discussions. Screening starting at age 40 years or 10 years before the youngest PCA diagnosis in a family was recommended for BRCA2 carriers, with consideration in HOXB13, BRCA1, ATM, and mismatch repair carriers. Collaborative (point-of-care) evaluation models between health care and genetic providers was endorsed to address the genetic counseling shortage. The genetic evaluation framework included optimal pretest informed consent, post-test discussion, cascade testing, and technology-based approaches. CONCLUSION This multidisciplinary, consensus-driven PCA genetic implementation framework provides novel guidance to clinicians and patients tailored to the precision era. Multiple research, education, and policy needs remain of importance.
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] Յ20 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
PURPOSE Our objective was to evaluate operating characteristics, particularly specificity and positive predictive value (PPV), by mapping plasma miR371 expression to actual clinical events in patients with a history of germ cell tumor. PATIENTS AND METHODS One hundred eleven male patients with a history of or newly diagnosed germ cell tumors were evaluable. Biospecimens obtained before confirmed clinical events were analyzed for miR371 expression with blinding of providers and laboratory personnel to analytic results or clinical status, respectively. Cases (patients with clinically confirmed active germ cell malignancy [aGCM]) and controls (patients with no clinically confirmed aGCM) were assigned over the course of the management. Patients were assigned risk status (high, low, or moderate) based on the composite clinical picture at time points in management. RESULTS Considering all cases and controls and results of prospectively obtained biosamples analyzed for miR371 expression, 46 (35%) of 132 samples had clinically confirmed aGCM over the course of management; 44 (96%) of these 46 patients had plasma miR371 expression (true positives) with no false positives. Two (4%) of 46 patients had no miRNA expression despite pathologic confirmation of aGCM (false negatives). Plasma miR371 expression in confirmed aGCM had a specificity, sensitivity, positive predictive value, and negative predictive value of 100%, 96%, 100%, and 98%, respectively. Interpretation of sensitivity and negative predictive value is limited by modest follow-up. Specificity and sensitivity were 100% and 98%, 100% and 92%, and 100% and 97% in the low-, moderate-, and high-risk groups, respectively, with a median follow-up time of 15 months. CONCLUSION Plasma miR371 expression predicts aGCM with high specificity and positive predictive value. Although other operating characteristics of miR371 await longer follow-up for more complete definition, the findings of a highly specific liquid biopsy strongly support moving forward with large-scale, real-world clinical trials to further define full operating characteristics and to identify clinical utility and areas of patient benefit.
IMPORTANCETreatment-related regret is an integrative, patient-centered measure that accounts for morbidity, oncologic outcomes, and anxiety associated with prostate cancer diagnosis and treatment.OBJECTIVE To assess the association between treatment approach, functional outcomes, and patient expectations and treatment-related regret among patients with localized prostate cancer. DESIGN, SETTING, AND PARTICIPANTSThis population-based, prospective cohort study used 5 Surveillance, Epidemiology, and End Results (SEER)-based registries in the Comparative Effectiveness Analysis of Surgery and Radiation cohort. Participants included men with clinically localized prostate cancer from
Purpose Robotic assisted radical prostatectomy has largely replaced open radical prostatectomy for the surgical management of prostate cancer despite conflicting evidence of superiority with respect to disease control or functional sequelae. Using population cohort data, in this study we examined sexual and urinary function in men undergoing open radical prostatectomy vs those undergoing robotic assisted radical prostatectomy. Materials and Methods Subjects surgically treated for prostate cancer were selected from 2 large population based prospective cohort studies, the Prostate Cancer Outcomes Study (enrolled 1994 to 1995) and the Comparative Effectiveness Analysis of Surgery and Radiation (enrolled 2011 to 2012). Subjects completed baseline, 6-month and 12-month standardized patient reported outcome measures. Main outcomes were between-group differences in functional outcome scores at 6 and 12 months using linear regression, and adjusting for baseline function, sociodemographic and clinical characteristics. Sensitivity analyses were used to evaluate outcomes between patients undergoing open radical prostatectomy and robotic assisted radical prostatectomy within and across CEASAR and PCOS. Results The combined cohort consisted of 2,438 men, 1,505 of whom underwent open radical prostatectomy and 933 of whom underwent robotic assisted radical prostatectomy. Men treated with robotic assisted radical prostatectomy reported better urinary function at 6 months (mean difference 3.77 points, 95% CI 1.09–6.44) but not at 12 months (1.19, −1.32–3.71). Subjects treated with robotic assisted radical prostatectomy also reported superior sexual function at 6 months (8.31, 6.02–10.56) and at 12 months (7.64, 5.25–10.03). Sensitivity analyses largely supported the sexual function findings with inconsistent support for urinary function results. Conclusions This population based study reveals that men undergoing robotic assisted radical prostatectomy likely experience less decline in early urinary continence and sexual function than those undergoing open radical prostatectomy. The clinical meaning of these differences is uncertain and longer followup will be required to establish whether these benefits are durable.
Background: Family history of bladder cancer confers an increased risk for concordant and discordant cancers in relatives. However, previous studies investigating this relationship lack any correction for smoking status of family members. We conducted a population-based study of cancer risks in relatives of bladder cancer patients and matched controls with exclusion of variant subtypes to improve the understanding of familial cancer clustering. Methods: Case subjects with urothelial carcinoma were identified using the Utah Cancer Registry and matched 1:5 to cancerfree controls from the Utah Population Database. Cox regression was used to determine the risk of cancer in first-degree relatives, second-degree relatives, first cousins, and spouses. A total of 229 251 relatives of case subjects and 1 197 552 relatives of matched control subjects were analyzed. To correct for smoking status, we performed a secondary analysis excluding families with elevated rates of smoking-related cancers. All statistical tests were two-sided. Results: First-and second-degree relatives of case subjects had an increased risk for any cancer diagnosis (hazard ratio [HR] ¼ 1.06, 95% confidence interval [CI] ¼ 1.03 to 1.09, P < .001; HR ¼ 1.04, 95% CI ¼ 1.02 to 1.07, P ¼ .001) and urothelial cancer (HR ¼ 1.73, 95% CI ¼ 1.50 to 1.99, P < .001; HR ¼ 1.35, 95% CI ¼ 1.21 to 1.51, P < .001). Site-specific analysis found increased risk for bladder (HR ¼ 1.69, 95% CI ¼ 1.47 to 1.95, P < .001), kidney (HR ¼ 1.30, 95% CI ¼ 1.08 to 1.57, P ¼ .006), cervical (HR ¼ 1.25, 95% CI ¼ 1.06 to 1.49, P ¼ .01), and lung cancer (HR ¼ 1.34, 95% CI ¼ 1.19 to 1.51, P < .001) in first-degree relatives. Second-degree relatives had increased risk for bladder (HR ¼ 1.35, 95% CI ¼ 1.2 to 1.5, P < .001) and thyroid cancer (HR ¼ 1.18, 95% CI ¼ 1.03 to 1.35, P ¼ .02). Spouses showed an increased risk for laryngeal (HR ¼ 2.68, 95% CI ¼ 1.02 to 7.05, P ¼ .04) and cervical cancer (HR ¼ 1.57, 95% CI ¼ 1.13 to 2.17, P ¼ .007). These results did not substantively change after correction for suspected smoking behaviors. Conclusion: Our results suggest familial urothelial cancer clustering independent of smoking, with increased risk in relatives for both concordant and discordant cancers, suggesting shared genetic or environmental roots. Identifying families with statistically significant risks for non-smoking-related urothelial cancer would be extremely informative for genetic linkage studies.
Climacturia is experienced by a substantial proportion of men after undergoing definitive treatment of prostate cancer. We found a complex relationship between stress urinary incontinence and climacturia, and noted that the presence of climacturia does not necessarily negatively impact sexual satisfaction.
PURPOSE Patients with cancer experience high rates of morbidity and unplanned health care utilization and may benefit from new models of care. We evaluated an adult oncology hospital at home program's rate of unplanned hospitalizations and health care costs and secondarily, emergency department (ED) use, length of hospital stays, and intensive care unit (ICU) admissions during the 30 days after enrollment. METHODS We conducted a prospective, nonrandomized, real-world cohort comparison of 367 hospitalized patients with cancer—169 patients consecutively admitted after hospital discharge to Huntsman at Home (HH), a hospital-at-home program, compared with 198 usual care patients concurrently identified at hospital discharge. All patients met clinical criteria for HH admission, but those in usual care lived outside the HH service area. Primary outcomes were the number of unplanned hospitalizations and costs during the 30 days after enrollment. Secondary outcomes included length of hospital stays, ICU admissions, and ED visits during the 30 days after enrollment. RESULTS Groups were comparable except that more women received HH care. In propensity-weighted analyses, the odds of unplanned hospitalizations was reduced in the HH group by 55% (odds ratio, 0.45, 95% CI, 0.29 to 0.70; P < .001) and health care costs were 47% lower (mean cost ratio, 0.53; 95% CI, 0.39 to 0.72; P < .001) over the 30-day period. Secondary outcomes also favored HH. Total hospital stay days were reduced by 1.1 days ( P = .004) and ED visits were reduced by 45% (odds ratio, 0.55; 95% CI, 0.33 to 0.92; P = .022). There was no evidence of a difference in ICU admissions ( P = .972). CONCLUSION This oncology hospital at home program shows initial promise as a model for oncology care that may lower unplanned health care utilization and health care costs.
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