Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial.

PURPOSE: The comparative effectiveness of transrectal and transperineal prostate biopsy in detecting clinically significant prostate cancer is not well understood. We conducted a randomized clinical trial to determine whether transperineal biopsy improves the detection of clinically significant prostate cancer. MATERIALS AND METHODS: Of the 840 men randomized, 93% were White, 44% had a previous biopsy, with a median age of 66 years and median PSA density of 0.14. Of these, 384 underwent transrectal and 398 underwent transperineal prostate biopsy. Prebiopsy prostate MRI was performed in 96% of men. Grade Group ≥ 2 prostate cancer was classified as clinically significant. Odds ratios were calculated using logistic regression to evaluate the effect of biopsy procedures on cancer detection rates. RESULTS: The detection rates of clinically significant prostate cancer were 47.1% and 43.2% (odds ratio 1.17; 95% CI, 0.88-1.55) for transrectal and transperineal biopsy, respectively. Age, PSA density, clinical stage and Prostate Imaging Reporting and Data System score were associated with the diagnosis of clinically significant cancer, whereas history of previous biopsy, anterior tumors, and biopsy procedure (transrectal or transperineal) were not. Clinically significant cancer detection rates in biopsy-naïve men undergoing MRI-targeted transrectal or transperineal biopsy were 59% and 62%, respectively. The overall cancer detection rates following transrectal and transperineal biopsy were 72.1% and 70.4%, respectively. CONCLUSIONS: There was no significant difference noted in the detection of clinically significant prostate cancer following transrectal or transperineal prostate biopsy. Urologists may utilize either biopsy procedure that best suits their patients' needs and practice setting.

Symptomatic and functional recovery after transurethral resection of bladder tumor: Data from ecological momentary symptom assessment.

OBJECTIVES: To quantitatively describe the nature, severity, and duration of symptoms and functional impairment during recovery from transurethral resection of bladder tumors. MATERIALS AND METHODS: All patients scheduled for transurethral resection were approached for enrollment in a text-message based ecological momentary symptom assessment platform. Nine patients reported outcomes were measured 7 days before surgery and on postoperative days 1, 2, 3, 5, 7, 10, and 14 using a 5-point Likert scale. Self-reported degree of hematuria was collected using a visual scale. Clinical data was collected via retrospective chart review. RESULTS: A total of 159 patients were analyzed. Postoperative symptoms were overall mild, with the largest differences from baseline to postoperative day 1 seen in dysuria (median 0/5 vs. 3/5) and ability to work (median 5/5 vs. 4/5). Recovery was generally rapid, with 76% of patients reporting ≥4/5 agreement with the statement "I feel recovered from surgery" by postoperative day 2, although 15% of patients reported persistently lower levels of agreement on postoperative day 10 or 14. Patients undergoing larger resections (≥2cm) did take longer to return to baseline in multiple symptom domains, but the difference of medians vs. those undergoing smaller resections was less than 1 day across all domains. Multivariable analysis suggested that receiving perioperative intravesical chemotherapy was associated with longer time to recovery. 84% of patients reported clear yellow urine by postoperative day 3. CONCLUSION: In this population, hematuria and negative effects on quality of life resulting from transurethral resection of bladder tumors were generally mild and short-lived, although a small number of patients experienced longer recoveries.

Atrophic Kidney-Like Lesion-Case Report and Review of the Literature.

Atrophic kidney-like lesion (AKLL) is a rare kidney lesion, which was recently suggested by the Genitourinary Pathology Society as a provisional entity. As of now, 16 examples of AKLL have been described in the literature. Here we report a new tumor which shows similar clinicopathologic characteristics with those previously reported in AKLL. Immunohistochemical (IHC) studies in the current lesion identified a biphasic staining pattern consisting of a mixture of WT1+/KRT7-/PAX8- large dilated cysts and WT-/KRT7+/PAX8+ small atrophic cysts. Histomorphologic features of AKLL overlap with several neoplastic and non-neoplastic entities which can lead to mischaracterization. Awareness of the differentiating features is likely important when evaluating these lesions.

Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial.

PURPOSE: Transrectal prostate biopsy has come under scrutiny due to potential for postbiopsy infections and transperineal prostate biopsy is being offered as the safer alternative. However, there is a lack of randomized comparative studies. Our goal was to directly evaluate infectious and noninfectious complications following the 2 biopsy procedures. MATERIALS AND METHODS: We conducted a prospective, pragmatic, randomized clinical study in men undergoing prostate biopsy. The participants underwent either transrectal or transperineal prostate biopsy in the office under local anesthesia. The primary outcome was a 30-day composite infectious complication rate, comprising of 1 or more components including fever, genitourinary infection, antibiotic prescriptions, office or emergency visits, hospitalization, or sepsis. Secondary outcomes included 30-day composite noninfectious complications (urinary or hemorrhagic). RESULTS: Of the 763 randomized participants, 718 underwent either transrectal (351) or transperineal (367) prostate biopsy. A composite infectious complication event occurred in 9 participants (2.6%) in the transrectal and 10 participants (2.7%) in the transperineal group (odds ratio, 1.06; 95% CI, 0.43 to 2.65; P = .99). None of the participants developed sepsis in either group. There were no between-group differences in any of the individual component infectious events. A composite noninfectious complication occurred in 6 (1.7%) and 8 (2.2%) participants in the transrectal and transperineal groups, respectively (odds ratio, 1.28; 95% CI, 0.44 to 3.73; P = .79). No participants required hospitalization or other interventions. CONCLUSIONS: Among men undergoing transperineal or transrectal prostate biopsy, we could not demonstrate any difference in the infectious or noninfectious complications. Both biopsy approaches remain clinically viable and safe.

Implementation and Assessment of No Opioid Prescription Strategy at Discharge After Major Urologic Cancer Surgery.

Importance: Postoperative opioid prescriptions are associated with delayed recovery, perioperative complications, opioid use disorder, and diversion of overprescribed opioids, which places the community at risk of opioid misuse or addiction. Objective: To assess a protocol for eliminating postdischarge opioid prescriptions after major urologic cancer surgery. Design, Setting, and Participants: This cohort study of the no opioid prescriptions at discharge after surgery (NOPIOIDS) protocol was conducted between May 2017 and June 2021 at a tertiary referral center. Patients undergoing open or minimally invasive radical cystectomy, radical or partial nephrectomy, and radical prostatectomy were sorted into the control group (usual opioids), the lead-in group (reduced opioids), and the NOPIOIDS group (no opioid prescriptions). Interventions: The NOPIOIDS group received a preadmission educational handout, postdischarge instructions for using nonopioid analgesics, and no routine opioid prescriptions. The lead-in group received a postdischarge instruction sheet and reduced opioid prescriptions at prescribers' discretion. The control group received opioid prescriptions at prescribers' discretion. Main Outcomes and Measures: Primary outcome measures included rate and dose of opioid prescriptions at discharge and for 30 days postdischarge. Additional outcome measures included patient-reported pain and satisfaction level, unplanned health care utilization, and postoperative complications. Results: Of 647 opioid-naive patients (mean [SD] age, 63.6 [10.0] years; 478 [73.9%] male; 586 [90.6%] White), the rate of opioid prescriptions at discharge for the control, the lead-in, and the NOPIOIDS groups was 80.9% (157 of 194), 57.9% (55 of 95), and 2.2% (8 of 358) (Kruskal-Wallis test of medians: P < .001), and the overall median (IQR) tablets prescribed was 14 (10-20), 4 (0-5.3), and 0 (0-0) per patient in the control, lead-in, and NOPIOIDS groups, respectively (Kruskal-Wallis test of medians: P < .001). In the NOPIOIDS group, median and mean opioid dose was 0 tablets for all procedure types, with the exception of kidney procedures (mean [SD], 0.5 [1.7] tablets). Patient-reported pain surveys were received from 358 patients (72.6%) in the NOPIOIDS group, demonstrating low pain scores (mean [SD], 2.5 [0.86]) and high satisfaction scores (mean [SD], 86.6 [3.8]). There was no increase in postoperative complications in the group with no opioid prescriptions. Conclusions and Relevance: This perioperative protocol, with emphasis on nonopioid alternatives and patient instructions, may be safe and effective in nearly eliminating the need for opioid prescriptions after major abdominopelvic cancer surgery without adversely affecting pain control, complications, or recovery.

Naming the Problem: Publishing Trends within in Urology on Race, Health Disparities and Structural Racism.

OBJECTIVES: To assess publishing trends regarding the contribution of societal systems on health disparities within the urology literature. METHODS: We performed a bibliometric analysis of the top 15 urology journals for titles and abstracts with the term race or ethnicity between 2000-2021. Articles were graded by the presence of (1) race, (2) disparities secondary to race, or (3) racial disparities secondary to structural biases. Frequencies were tabulated and logistic regression was used to determine odds of disparities publishing. RESULTS: Our query returned 934 articles for review. In 484 (52%) articles, race was mentioned as a demographic/covariate. 110 (12%) abstracts noted a racial health disparity and only 2 articles implicated racism. Rates of more direct language varied significantly by journal and year of publication. Discussion of disparities increased over time, ranging from 0% in 2002 to 25% in 2020 (P-trend <.001). Logistic regression demonstrated an 11% annual increase in the likelihood of disparity publishing (OR=1.11, 95%CI=1.08-1.14; P<.001). CONCLUSIONS: While it is widely acknowledged that race is a determinant of health, often "race" itself is ascribed the risk when societal inequities are largely at fault. Despite the frequent use of race as a key covariate within the urologic literature, health-disparities relating to structural racism are rarely explicitly named. In order to address the systemic biases that underpin these inequities, increased awareness through clear language in publishing is needed.

Harnessing choice architecture in urologic practice: Implementation of an opioid-sparing protocol grounded in cognitive behavioral theory.

PURPOSE: Opioids are prescribed excessively following surgery. As many urologic oncology procedures are performed minimally invasively, an opportunity exists to push forward initiatives to minimize postoperative opioid use. MATERIALS AND METHODS: A quality improvement initiative to reduce inpatient opioid prescribing was launched at a tertiary cancer center. In Phase I (December 2019-July 2020), providers were instructed to start standing acetaminophen. In Phase II (beginning August 2020), education was provided to the entire care team and ordersets were modified to an opioid sparing protocol (OSP). We analyzed the proportion of minimally invasive surgery (MIS) prostatectomy and nephrectomy patients that adhered to an OSP during each phase and compared them to controls from the preceding 2 years. RESULTS: A total of 303, 153, and 839 patients underwent MIS during the Phase I, Phase II, and control periods respectively. The proportion of patients adhering to an OSP increased from 16% at the beginning of Phase I to 76% at the end of Phase II (p-trend < 0.001). The median total oral morphine equivalents for oral opioids declined from 20 mg and 40 mg at baseline for prostatectomy and nephrectomy patients respectively to 0 mg for both groups (p-trends < 0.001). Multivariable analysis found that patients received 22% and 81% less oral morphine equivalents during Phase I and II respectively compared to the control period (P < 0.001). CONCLUSIONS: Adherence to an OSP is most effective when initiatives incorporate the entire team and are supported by nudge theory-based structural changes. Using these strategies, most patients following urologic MIS can dramatically reduce opioid use postoperatively.

Assessment of Prostate Cancer Treatment Among Black and White Patients During the COVID-19 Pandemic.

Importance: Early in the COVID-19 pandemic, racial/ethnic minority communities disproportionately experienced poor outcomes; however, the association of the pandemic with prostate cancer (PCa) care is unknown. Objective: To assess the association between race and PCa care delivery for Black and White patients during the first wave of the COVID-19 pandemic. Design, Setting, and Participants: This multicenter, regional, collaborative, retrospective cohort study compared prostatectomy rates between Black and White patients with untreated nonmetastatic PCa during the COVID-19 pandemic (269 patients from March 16 to May 15, 2020) and prior (378 patients from March 11 to May 10, 2019). Main Outcomes and Measures: Prostatectomy rates. Results: Of the 647 men with nonmetastatic PCa, 172 (26.6%) were non-Hispanic Black men, and 475 (73.4%) were non-Hispanic White men. Black men were significantly less likely to undergo prostatectomy during the pandemic compared with White patients (1 of 76 [1.3%] vs 50 of 193 [25.9%]; P < .001), despite similar COVID-19 risk factors, biopsy Gleason grade groups, and comparable prostatectomy rates prior to the pandemic (17 of 96 [17.7%] vs 54 of 282 [19.1%]; P = .75). Black men had higher median prostate-specific antigen levels prior to biopsy (8.8 ng/mL [interquartile range, 5.3-15.2 ng/mL] vs 7.2 ng/mL [interquartile range, 5.1-11.1 ng/mL]; P = .04). A linear combination of regression coefficients with an interaction term for year demonstrated an odds ratio for likelihood of surgery of 0.06 (95% CI, 0.01-0.35; P = .002) for Black patients and 1.41 (95% CI, 0.81-2.44; P = .23) for White patients during the pandemic compared with prior to the pandemic. Changes in surgical volume varied by site (from a 33% increase to complete shutdown), with sites that experienced the largest reduction in cancer surgery caring for a greater proportion of Black patients. Conclusions and Relevance: In this large multi-institutional regional collaborative cohort study, the odds of PCa surgery were lower among Black patients compared with White patients during the initial wave of the COVID-19 pandemic. Although localized PCa does not require immediate treatment, the lessons from this study suggest systemic inequities within health care and are likely applicable across medical specialties. Public health efforts are needed to fully recognize the unintended consequence of diversion of cancer resources to the COVID-19 pandemic to develop balanced mitigation strategies as viral rates continue to fluctuate.

Impact of COVID-19 on Initial Management and Evaluation of Prostate Cancer.

INTRODUCTION: The COVID-19 pandemic starkly affected all aspects of health care, forcing many to divert resources towards emergent patient needs while decreasing emphasis on routine cancer care. We compared prostate cancer care before and during the pandemic in a multi-institutional cohort. METHODS: A prospective regional collaborative was queried to assess practice pattern variations relative to the initial COVID-19 lockdown (March 16 to May 15, 2020). The preceding 10 months were selected for comparison. The impact of the lockdown was evaluated on the basis of 1) weekly trends in biopsy and radical prostatectomy volumes, 2) comparisons between those undergoing prostate biopsy, and 3) clinicopathological characteristics within radical prostatectomy patients. Categorical variables were compared using Fisher's exact and Pearson's chi-square tests, and Wilcoxon rank sum test to evaluate continuous covariates. RESULTS: Overall, there was a 55% and 39% decline in biopsy and prostatectomy volumes, respectively. During the pandemic, biopsy patients were younger with fewer COVID-19 severity risk factors (17.0% vs 9.7% no risk factors, p=0.023) and prostatectomy patients had higher grade group (GG; 45.6% >GG 4 vs 28%, p=0.01). Large variation in the change in procedural volume was noted across practice sites. CONCLUSION: In a multi-institutional assessment of surgical and diagnostic delay for prostate cancer, we found a non-uniform decline in procedural volume across sites. Future analyses within this cohort are needed to further discern the effects of care delays related to COVID-19.

Assessing Contemporary Trends in Female Speakership within Urologic Oncology.

OBJECTIVE: To evaluate multidisciplinary female representation at urologic oncology conferences, we reviewed speakership trends at contemporary Society of Urologic Oncology (SUO) and American Society of Clinical Oncology Genitourinary Symposium (GU-ASCO) annual meetings. METHODS: Meeting programs from SUO and GU-ASCO from 2015 to 2019 were analyzed. Biographical information was determined by querying institutional websites and social/professional media platforms. Statistical analyses were performed to assess for differences and relationships between male and female authorship based on gender, specialty, professional, and educational factors. RESULTS: We identified 1102 speakers at genitourinary oncology conferences. Overall, 222 (20%) were female. There was no significant difference between female speakership rates at SUO and GU-ASCO. The overall proportion of female speakers increased over time, but not when analyzing each individual subspecialty conference separately. Several professional and educational differences were noted between genders. Female speakers were more likely to be medical oncologists (P <.001), have more recent years of graduation (2001 vs 1996, P <.001), hold an additional advanced degree (OR 2.09, P = .005), and speak in sessions where other women served as chair (OR 1.42, P = .044). Conversely, female speakers had lower odds of delivering a plenary or keynote address (OR 0.28, P = .015). CONCLUSION: We identified a significantly positive trend towards increased female representation within contemporary genitourinary conferences over time; these trends did not remain significant when analyzing each meeting separately. Several important disparities between men and women speakers were identified. Our data suggests that inclusion of women in planning committees may help reduce gender bias and promote diversity within urologic oncology.

Increased resource use in men with metastatic prostate cancer does not result in improved survival or quality of care at the end of life.

BACKGROUND: Cancer care and end-of-life (EOL) care contribute substantially to health care expenditures. Outside of clinical trials, to our knowledge there exists no standardized protocol to monitor disease progression in men with metastatic prostate cancer (mPCa). The objective of the current study was to evaluate the factors and outcomes associated with increased imaging and serum prostate-specific antigen use in men with mPCa. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data from 2004 to 2012, the authors identified men diagnosed with mPCa with at least 6 months of follow-up. Extreme users were classified as those who had either received prostate-specific antigen testing greater than once per month, or who underwent cross-sectional imaging or bone scan more frequently than every 2 months over a 6-month period. Associations between extreme use and survival outcomes, costs, and quality of care at EOL, as measured by timing of hospice referral, frequency of emergency department visits, length of stay, and intensive care unit or hospital admissions, were examined. RESULTS: Overall, a total of 3026 men with mPCa were identified, 791 of whom (26%) were defined as extreme users. Extreme users were more commonly young, white/non-Hispanic, married, higher earning, and more educated (P<.001, respectively). Extreme use was not associated with improved quality of care at EOL. Yearly health care costs after diagnosis were 36.4% higher among extreme users (95% confidence interval, 27.4%-45.3%; P<.001). CONCLUSIONS: Increased monitoring among men with mPCa significantly increases health care costs, without a definitive improvement in survival nor quality of care at EOL noted. Monitoring for disease progression outside of clinical trials should be reserved for those in whom findings will change management. Cancer 2018;124:2212-9. © 2018 American Cancer Society.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Contemporary Incidence and Outcomes of Prostate Cancer Lymph Node Metastases.

PURPOSE: The incidence of localized prostate cancer has decreased with shifts in prostate cancer screening. While recent population based studies demonstrated a stable incidence of locoregional prostate cancer, they categorized organ confined, extraprostatic and lymph node positive disease together. However, to our knowledge the contemporary incidence of prostate cancer with pelvic lymph node metastases remains unknown. MATERIALS AND METHODS: We used SEER (Surveillance, Epidemiology and End Results) data from 2004 to 2014 to identify men diagnosed with prostate cancer. We analyzed trends in the age standardized prostate cancer incidence by stage. The impact of disease extent on mortality was assessed by adjusted Cox proportional hazard analysis. RESULTS: During the study period the annual incidence of nonmetastatic prostate cancer decreased from 5,119.1 to 2,931.9 per million men (IR 0.57, 95% CI 0.56-0.58, p <0.01) while the incidence of pelvic lymph node metastases increased from 54.1 to 79.5 per million men (IR 1.47, 95% CI 1.33-1.62, p <0.01). The incidence of distant metastases in men 75 years old or older reached a nadir in 2011 compared to 2004 (IR 0.81, 95% CI 0.74-0.90, p <0.01) and it increased in 2012 compared to 2011 (IR 1.13, 95% CI 1.02-1.24, p <0.05). The risk of cancer specific mortality significantly increased in men diagnosed with pelvic lymph node metastases (HR 4.5, 95% CI 4.2-4.9, p <0.01) and distant metastases (HR 21.9, 95% CI 21.2-22.7, p <0.01) compared to men with nonmetastatic disease. CONCLUSIONS: The incidence of pelvic lymph node metastases is increasing coincident with a decline in the detection of localized disease. Whether this portends an increase in the burden of advanced disease or simply reflects decreased lead time remains unclear. However, this should be monitored closely as the increase in N1 disease reflects an increase in incurable prostate cancer at diagnosis.

Population-based study of the incidence and survival for intraductal carcinoma of the prostate.

PURPOSE: The degree to which intraductal carcinoma of the prostate (IDC-P) affects clinical course remains poorly understood owing to small sample sizes from single-center studies. We sought to determine prognostic factors and outcomes associated with IDC-P in radical prostatectomy (RP) specimens. MATERIALS AND METHODS: This is a retrospective study of RP during 2004 to 2013 using Surveillance, Epidemiology, and End Results to compare IDC-P with non-IDC-P. The effect of IDC-P on overall and disease-specific survival was assessed using Cox regression with a median follow-up of 4.8 years (interquartile range [IQR]: 2.6-7.0y; P = 0.01). Median prostate-specific antigen at diagnosis in IDC-P vs. non-IDC-P was similar (P = 0.23) at 6.2 (IQR: 4.6-13.0) vs. 6.1ng/ml (IQR: 4.6-9.8). RESULTS: We identified 159,777 RP from 2004 to 2013, and 242 (0.002%) had IDC-P pathologic features. IDC-P was associated with a greater likelihood of extraprostatic stage, pT3/T4, 45.9% vs. 21.6% (P<0.001), higher grade, GS≥ 7, 79.3% vs. 62.7% (P<0.001), lymph node metastases, 5.8% vs. 2.4% (P<0.001), and positive surgical margins, 25.6% vs. 19.5% (P = 0.02). IDC-P was associated with a 3-fold increase in prostate cancer-specific mortality relative to non-IDC-P (hazard ratio = 3.0, 95% CI: 1.5-5.7; P<0.01). Limitations include retrospective design and potential underreporting of IDC-P that leads to underestimation of the true effect size. CONCLUSIONS: The significance of IDC-P features has been recently recognized by the World Health Organization and it is associated with high-grade, extraprostatic features, and worse prostate cancer-specific mortality. Understanding its prognostic significance better guides adjuvant therapies and clinical trials.