Clinician-Reported Management Recommendations in Response to Universal Germline Genetic Testing in Patients With Prostate Cancer.

PURPOSE: Identification of pathogenic germline variants in patients with prostate cancer can help inform treatment selection, screening for secondary malignancies, and cascade testing. Limited real-world data are available on clinician recommendations following germline genetic testing in patients with prostate cancer. MATERIALS AND METHODS: Patient data and clinician recommendations were collected from unselected patients with prostate cancer who underwent germline testing through the PROCLAIM trial. Differences among groups of patients were determined by 2-tailed Fisher's exact test with significance set at P < .05. Logistic regression was performed to assess the influence of test results in clinical decision-making while controlling for time of diagnosis (newly vs previously diagnosed). RESULTS: Among 982 patients, 100 (10%) were positive (≥1 pathogenic germline variant), 482 (49%) had uncertain results (≥1 variant of uncertain significance), and 400 (41%) were negative. Patients with positive results were significantly more likely than those with negative or uncertain results to receive recommendations for treatment changes (18% vs 1.4%, P < .001), follow-up changes (64% vs 11%, P < .001), and cascade testing (71% vs 5.4%, P < .001). Logistic regression demonstrated that positive and uncertain results were significantly associated with both changes to treatment and follow-up (P < .001) when controlling for new or previous diagnosis. CONCLUSIONS: Germline genetic testing results informed clinical recommendations for patients with prostate cancer, especially in patients with positive results. Higher than anticipated rates of clinical management changes in patients with uncertain results highlight the need for increased genetic education of clinicians treating patients with prostate cancer.

Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial.

BACKGROUND: Prostate cancer (PCa) patients with pathogenic/likely pathogenic germline variants (PGVs) in cancer predisposition genes may be eligible for U.S. Food and Drug Administration-approved targeted therapies, clinical trials, or enhanced screening. Studies suggest that eligible patients are missing genetics-informed care due to restrictive testing criteria. OBJECTIVE: To establish the prevalence of actionable PGVs among prospectively accrued, unselected PCa patients, stratified by their guideline eligibility. DESIGN, SETTING, AND PARTICIPANTS: Consecutive, unselected PCa patients were enrolled at 15 sites in the USA from October 2019 to August 2021, and had multigene cancer panel testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Correlates between the prevalence of PGVs and clinician-reported demographic and clinical characteristics were examined. RESULTS AND LIMITATIONS: Among 958 patients (median [quartiles] age at diagnosis 65 [60, 71] yr), 627 (65%) had low- or intermediate-risk disease (grade group 1, 2, or 3). A total of 77 PGVs in 17 genes were identified in 74 patients (7.7%, 95% confidence interval [CI] 6.2-9.6%). No significant difference was found in the prevalence of PGVs among patients who met the 2019 National Comprehensive Cancer Network Prostate criteria (8.8%, 43/486, 95% CI 6.6-12%) versus those who did not (6.6%, 31/472, 95% CI 4.6-9.2%; odds ratio 1.38, 95% CI 0.85-2.23), indicating that these criteria would miss 42% of patients (31/74, 95% CI 31-53%) with PGVs. The criteria were less effective at predicting PGVs in patients from under-represented populations. Most PGVs (81%, 60/74) were potentially clinically actionable. Limitations include the inability to stratify analyses based on individual ethnicity due to low numbers of non-White patients with PGVs. CONCLUSIONS: Our results indicate that almost half of PCa patients with PGVs are missed by current testing guidelines. Comprehensive germline genetic testing should be offered to all patients with PCa. PATIENT SUMMARY: One in 13 patients with prostate cancer carries an inherited variant that may be actionable for the patient's current care or prevention of future cancer, and could benefit from expanded testing criteria.

Implementing Continuous Quality Improvement in an Integrated Community Urology Practice: Lessons Learned.

OBJECTIVE: To determine the effectiveness of 2 different continuous quality improvement interventions in an integrated community urology practice. We specifically assessed the impact of audited physician feedback on improving physicians' adoption of active surveillance for low-risk prostate cancer (CaP) and adherence to a prostate biopsy time-out intervention. MATERIALS AND METHODS: The electronic medical records of Genesis Healthcare Partners were analyzed between August 24, 2011 and September 30, 2020 to evaluate the performance of 2 quality interventions: audited physician feedback to improve active surveillance adoption in low-risk CaP patients, and audited physician feedback to promote adherence to an electronic medical records embedded prostate biopsy time-out template. Physician and Genesis Healthcare Partners group adherence to each quality initiative was compared before and after each intervention type using ANOVA testing. RESULTS: For active surveillance, we consistently saw an increase in active surveillance adoption for low risk CaP patients in association with continuous audited feedback (P < .001). Adherence to the prostate biopsy time-out template improved when audited feedback was provided (P < .001). CONCLUSION: The implementation of clinical guidelines into routine clinical practice remains challenging and poses an obstacle to the improvement of United States healthcare quality. Continuous quality improvement should be a dynamic process, and in our experience, audited feedback coupled with education is most effective.

Leveraging the Electronic Medical Record Improves Prostate Cancer Clinical Staging in a Community Urology Practice.

INTRODUCTION: Clinical tumor staging is an important component of risk stratification, which is central in assessment and treatment of patients with prostate cancer. We evaluated the potential of an examination based tumor staging template embedded within the electronic medical record to improve consistency and clarity of clinical tumor staging. METHODS: We conducted a retrospective analysis before template implementation (January to March 2017), followed by prospective analysis after implementation (April to August 2017). Physicians were educated on use and importance of the staging template prior to implementation. Assessment of digital rectal examination clarity included confident-explicit (cT stage documented), confident-implicit (stage inexplicit, cT stage interpreted) and unconfident (inability to discern cT stage). Clarity and consistency of tumor staging before and after template implementation were compared using a chi-square test. RESULTS: A total of 573 biopsies were analyzed: 234 before template use (40%) and 339 after (60%). In men at risk for prostate cancer explicit staging increased from 16% to 60% (p <0.001) following implementation of the staging template. Overall staging (explicit plus implicit) increased (from 74% to 92%, p <0.001), while unconfident staging decreased (from 26% to 8%, p <0.001) after implementation. In men with positive biopsies (309) explicit staging increased (from 29% to 64%, p <0.001) and overall staging increased (from 76% to 92%, p <0.001), while unconfident staging decreased (from 24% to 8%, p <0.001). CONCLUSIONS: Accurate prostate cancer clinical staging is important in risk stratification and treatment. We demonstrate the ability of a standardized, electronic medical record embedded, American Joint Committee on Cancer based template to improve the consistency and clarity of clinical staging in prostate cancer.

Low Penetrance Germline Genetic Testing: Role for Risk Stratification in Prostate Cancer Screening and Examples From Clinical Practice.

Broad-based prostate-specific antigen (PSA) screening has saved lives but at a substantial human and financial cost. One way of mitigating this harm, while maintaining and possibly improving the benefit, is by focusing screening efforts on men at higher risk. With age, race, and family history as the only risk factors, many men lack any reliable data to inform their prostate cancer (PCa) screening decisions. Complexities including history of previous negative biopsies, interpretation of negative and/or equivocal mpMRI findings, and patient comorbidities further compound the already complicated decisions surrounding PCa screening and early detection. The authors present cases that provide real-world examples of how a single nucleotide polymorphism-based test can provide patients and providers with personalized PCa risk assessments and allow for development of improved risk-stratified screening regimens.

Change in prostate cancer presentation coinciding with USPSTF screening recommendations at a community-based urology practice.

OBJECTIVE: The benefits of prostate-specific antigen (PSA)-based prostate cancer screening are controversial. We sought to determine the change in prostate cancer presentation coinciding with the release of the United States Preventative Services Task Force recommendations against screening in a high-volume community-based urology practice. METHODS: Characteristics of men presenting for an elevated PSA at a community urology practice from August 2011 to August 2015 were queried from a prospectively collected database. A retrospective analysis of presenting PSA, Gleason grade at biopsy, and prostatectomy as well as clinical and pathologic stage was performed. Kruskal-Wallis rank sum and chi-square tests were used for analysis. RESULTS: Referrals for elevated PSA decreased from 933 in year 1 to 816 by year 4 (12.5% decrease) with a concomitant reduction in biopsies performed in newly referred men from 461 to 356 (22.8% decrease, P = 0.02). The proportion of men presenting with PSAs>10 increased from 28.1% to 36.8% (P = 0.009). First-time biopsy-positivity rate increased from 48.4% to 62.4% with a rise in the proportion having Gleason≥7 from 51.6% to 69.7% (P = 0.0001). Of the 578 men who underwent radical prostatectomy, there was a 19.4% increase in Gleason≥7 tumors (P = 0.01). CONCLUSIONS: Our findings demonstrate a decrease in elevated PSA referrals, increase in PSA at the time of referral, decrease in detection of low-risk disease, and increase in detection of intermediate-/high-risk disease in a high-volume, multisite, community-based urology practice, coinciding with the United States Preventative Services Task Force recommendations against PSA screening.

Prostate Biopsy Complications: A Dual Analysis.

OBJECTIVE: To measure prostate needle biopsy (PNB)-associated complications and place of treatment: inpatient hospitalization and outpatient treatment. An electronic medical record (EMR) data query is compared to a patient questionnaire survey. MATERIALS AND METHODS: A total of 2410 patients underwent 2588 biopsies and were evaluated for PNB-associated complications. Two approaches were used: (1) EMR analysis based on International Classification of Diseases, Ninth Revision, and Current Procedural Terminology coding and chart review; and (2) patient-reported questionnaire and chart review validation. Serious complications were defined as any complication leading to a related hospitalization, visit to the emergency department (ED), urgent care (UC), or doctor's office within 30 days of the biopsy. RESULTS: The EMR study revealed 69 (2.67%) serious complications leading to either hospitalization or treatment at an ED, UC, or doctor's office. Thirty serious complications led to hospitalization (1.16%), 14 patients (0.54%) were treated at the ED, 1 was managed at a UC (0.04%), and 24 (0.93%) were treated at the doctor's office. Of the 847 (35.1%) questionnaires considered appropriate for analysis, 36 (4.25%) reported treatment in either the hospital, ED, UC, or doctor's office. Nine patients (1.06%) reported being hospitalized within 30 days of the procedure, whereas 27 patients (3.19%) were treated in an outpatient setting, 8 (0.94%) at the ED, 3 (0.35%) at a UC, and 16 (1.89%) at the doctor's office. CONCLUSION: Our dual analysis study indicates a slightly greater than 1% incidence of hospitalization due to serious complications following PNB. Serious complications appear to be more frequently managed outside the hospital setting (ED, UC, and doctor's office).

Active Surveillance of Prostate Cancer in a Community Practice: How to Measure, Manage, and Improve?

OBJECTIVE: To measure past active surveillance (AS) adoption rates, institute the best practice, and measure the AS adoption rates following implementation. We report our findings over a 3-year period. METHODS: Patient prostate needle biopsy and treatment data from the period August 2011 to August 2014 were retrieved from an integrated electronic medical records (Allscripts) and stored in a Microsoft Access database for analysis. Structured data were queried using the automated software program WizMD and unstructured data were abstracted by manual review. AS adoption was calculated according to four different selection criteria. Between 2013 and 2014, physicians at Genesis Healthcare Partners (GHP) underwent an educational training program on the University of California, San Diego/GHP AS best practice for managing low-risk prostate cancer patients and were provided report cards on their AS adoption and comparative reporting. RESULTS: AS adoption increased for the 3 years of the study. AS adoption for all newly diagnosed patients managed at GHP increased from 12.9% to 14.74%. AS adoption for patients with low-risk prostate cancer (as defined by the National Comprehensive Cancer Network) increased from 31.90% to 58.46% from year 1 to year 3 of the study (P < .001), and AS adoption for the most strict (restrictive) criteria increased from 43.75% to 82.61% (P < .001) after the educational and comparative reporting intervention. CONCLUSION: These data highlight the potential benefit of physician education and comparative reporting to enhance AS adoption. AS adoption rates vary according to selection criteria used for analysis. Carefully selected outcomes from evidence-based guidelines have the potential to enhance medical quality.

Bladder perforation associated with hot tub.

INTRODUCTION: Bladder perforation is a rare and life-threatening event. Timely diagnosis may prevent further injury-related morbidity and mortality. Aim. To present a case of bladder injury associated with masturbation in a hot tub. METHODS: This report describes a case of bladder perforation in a 54-year-old female who presented to the emergency department 2 days after masturbation with a water jet. RESULTS: Following percutaneous drainage and intraoperative closure of the bladder, the patient was discharged on postoperative day four and has had no sequelae. CONCLUSION: Cross-sectional imaging and cystography can facilitate immediate diagnosis and expeditious treatment of bladder injury associated with masturbation in a hot tub.