Active Surveillance as Initial Management of Newly Diagnosed Prostate Cancer: Data from the PURC.

PURPOSE: We describe contemporary active surveillance utilization and variation in a regional prostate cancer collaborative. We identified demographic and disease specific factors associated with active surveillance in men with newly diagnosed prostate cancer. MATERIALS AND METHODS: We analyzed data from the PURC (Pennsylvania Urologic Regional Collaborative), a cooperative effort of urology practices in southeastern Pennsylvania and New Jersey. We determined the rates of active surveillance among men with newly diagnosed NCCN® (National Comprehensive Cancer Network®) very low, low or intermediate prostate cancer and compared the rates among participating practices and providers. Univariate and multivariable analyses were used to identify factors associated with active surveillance utilization. RESULTS: A total of 1,880 men met inclusion criteria. Of the men with NCCN very low or low risk prostate cancer 57.4% underwent active surveillance as the initial management strategy. Increasing age was significantly associated with active surveillance (p <0.001) while adverse clinicopathological variables were associated with decreased active surveillance use. Substantial variation in active surveillance utilization was observed among practices and providers. CONCLUSIONS: More than 50% of men with low risk disease in the PURC collaborative were treated with active surveillance. However, substantial variation in active surveillance rates were observed among practices and providers in academic and community settings. Advanced age and favorable clinicopathological factors were strongly associated with active surveillance. Analysis of regional collaboratives such as the PURC may allow for the development of strategies to better standardize treatment in men with prostate cancer and offer active surveillance in a more uniform and systematic fashion.

Perioperative Outcomes Following Partial Nephrectomy Performed on Patients Remaining on Antiplatelet Therapy.

PURPOSE: We evaluated the risk of bleeding complications in patients undergoing partial nephrectomy in whom perioperative antiplatelet therapy was continued, as antiplatelet therapy is increasingly used and hemorrhage is a significant concern in partial nephrectomy. MATERIALS AND METHODS: In this 2-center retrospective analysis 1,097 patients underwent partial nephrectomy between 2000 and 2014. The cohort was split into 3 groups of perioperative continuation of antiplatelet therapy (group 1-67), antiplatelet therapy stopped preoperatively (group 2-254) and no chronic antiplatelet therapy (group 3-776). Bleeding complications were defined as any transfusion, or any hospital readmission or secondary procedure performed for hemorrhage. Multivariable analysis was performed to elucidate independent risk factors for bleeding complications. RESULTS: Patients in group 1 were older (median age 66 years vs 64 and 57 years in groups 2/3, p <0.0001), and had greater comorbidity (median ASA classification score 3 vs 2 and 2, p <0.0001). Group 1 had a higher rate of bleeding complications (20.9% vs 7.1% and 6.4%, p <0.0001) and transfusions (16.4% vs 5.9% and 5.4%, p=0.002). Multivariable analysis revealed continued antiplatelet therapy was an independent predictor of bleeding complications (OR 2.19, 95% CI 1.06-4.51, p=0.03). These findings appear attributable to intraoperative clopidogrel use. On multivariable analysis the use of aspirin alone was not associated with bleeding complications (OR 1.64, 95% CI 0.72-3.75, p=0.24). CONCLUSIONS: The risk of bleeding complications due to antiplatelet therapy use at partial nephrectomy may be due to clopidogrel. The need to continue perioperative aspirin alone does not appear to be a contraindication to the safe performance of partial nephrectomy.

Surgical Apgar Score predicts an increased risk of major complications and death after renal mass excision.

PURPOSE: Tailoring perioperative management to minimize the postoperative complication rates depends on reliable prognostication of patients most at risk. The Surgical Apgar Score is an objective measure of the operative course validated to predict major complications and death after general/vascular surgery. We assessed the ability of the Surgical Apgar Score to identify patients most at risk for postoperative morbidity and mortality after renal mass excision. MATERIALS AND METHODS: Data for 886 patients undergoing renal mass excision via radical or partial nephrectomy from 2010 to 2013 were extracted from a prospectively collected database. The Surgical Apgar Score was calculated using electronic anesthesia records. Major postoperative complications, readmission and reoperation within 30 days of surgery as well as 90-day mortality were examined. RESULTS: Overall 13.2% of patients experienced major postoperative complications at 30 days. Clavien grade I, II, III, IV and V complications were experienced by 1.7%, 2.9%, 5.8%, 1.9% and 0.9%, respectively. The 90-day all cause mortality rate was 1.4%. The Surgical Apgar Score was significantly lower in patients experiencing major complications (mean 7.3 vs 7.8, p=0.004) and death (6.3 vs 7.7, p=0.03). Patients with a Surgical Apgar Score of 4 or less were 3.7 times more likely to experience a major complication (p=0.01) and 24 times more likely to die within 90 days of surgery (p=0.0007) compared to patients with a Surgical Apgar Score greater than 8. CONCLUSIONS: The Surgical Apgar Score is an easily collected metric that can identify patients at higher risk for major complications and death after renal mass excision. A prospective trial to help further delineate the optimal use of this tool in an adjusted perioperative management approach with patients undergoing renal mass excision is warranted.

Hypoalbuminaemia is associated with mortality in patients undergoing cytoreductive nephrectomy.

OBJECTIVE: To evaluate whether poor nutrition is associated with mortality in patients undergoing cytoreductive nephrectomy (CN) for metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: A multi-institutional review of prospective databases identified 246 patients meeting inclusion criteria who underwent CN for mRCC from 1993 to 2012. Nutritional markers evaluated were: body mass index <18.5 kg/m(2) , serum albumin <3.5 g/dL, or preoperative weight loss of ≥5% of body weight. Primary outcomes were overall (OS) and disease-specific survival (DSS). Secondary outcome was 'early mortality' defined as death at ≤6 months of surgery. Survival curves were estimated using the Kaplan-Meier product-limit method and multivariate analysis using logistic regression was used to test associations between nutritional markers and survival outcomes. RESULTS: In all, 119 patients (median follow-up 17 months) were categorised as having any abnormal nutrition parameter (48%). Hypoalbuminaemia was the only independent predictor of OS and DSS (OS: median 8 vs 23 months, P < 0.001; DSS: 11 vs 33 months, P < 0.001). On multivariate analysis, hypoalbuminaemia remained a significant predictor of death for both overall [hazard ratio (HR) 2, 95% confidence interval (CI) 1.4-2.8; P < 0.001) and disease-specific mortality (HR 2.2, 95% CI 1.4-3.3; P < 0.001). Hypoalbuminaemia was also associated with early mortality (overall: P < 0.001 and disease specific: P = 0.002). CONCLUSION: Patients with mRCC and hypoalbuminaemia undergoing CN have decreased OS and CSS, and increased risk of all-cause and disease-specific early mortality. As such, serum albumin may help risk stratify patients selected as candidates for CN. Furthermore, future work should evaluate whether nutritional depletion is a modifiable risk factor.

Piperlongumine inhibits NF-κB activity and attenuates aggressive growth characteristics of prostate cancer cells.

BACKGROUND: Elevated NF-κB activity has been previously demonstrated in prostate cancer cell lines as hormone-independent or metastatic characteristics develop. We look at the effects of piperlongumine (PL), a biologically active alkaloid/amide present in piper longum plant, on the NF-κB pathway in androgen-independent prostate cancer cells. METHODS: NF-κB activity was evaluated using Luciferase reporter assays and Western blot analysis of p50 and p65 nuclear translocation. IL-6, IL-8, and MMP-9 levels were assessed using ELISA. Cellular adhesion and invasiveness properties of prostate cancer cells treated with PL were also assessed. RESULTS: NF-κB DNA-binding activity was directly down-regulated with increasing concentrations of PL, along with decreased nuclear translocation of p50 and p65 subunits. Expression of IL-6, IL-8, MMP-9, and ICAM-1 was attenuated, and a decrease of cell-to-matrix adhesion and invasiveness properties of prostate cancer cells were observed. CONCLUSIONS: PL-mediated inhibition of NF-κB activity decreases aggressive growth characteristics of prostate cancer cells in vitro.

Coexisting hybrid malignancy in a solitary sporadic solid benign renal mass: implications for treating patients following renal biopsy.

PURPOSE: Concern regarding coexisting malignant pathology in benign renal tumors deters renal biopsy and questions its validity. We examined the rates of coexisting malignant and high grade pathology in resected benign solid solitary renal tumors. MATERIALS AND METHODS: Using our prospectively maintained database we identified 1,829 patients with a solitary solid renal tumor who underwent surgical resection between 1994 and 2012. Lesions containing elements of renal oncocytoma, angiomyolipoma or another benign pathology formed the basis for this analysis. Patients with an oncocytic malignancy without classic oncocytoma and those with known hereditary syndromes were excluded from study. RESULTS: We identified 147 patients with pathologically proven elements of renal oncocytoma (96), angiomyolipoma (44) or another solid benign pathology (7). Median tumor size was 3.0 cm (IQR 2.2-4.5). As quantified by the R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior and location relative to polar lines) nephrometry score, tumor anatomical complexity was low in 28% of cases, moderate in 56% and high in 16%. Only 4 patients (2.7%) were documented as having hybrid malignant pathology, all involving chromophobe renal cell carcinoma in the setting of renal oncocytoma. At a median followup of 44 months (IQR 33-55) no patient with a hybrid tumor experienced regional or metastatic progression. CONCLUSIONS: In our cohort of patients with a solitary, sporadic, solid benign renal mass fewer than 3% of tumors showed coexisting hybrid malignancy. Importantly, no patient harbored coexisting high grade pathology. These data suggest that uncertainty regarding hybrid malignant pathology coexisting with benign pathological components should not deter renal biopsy, especially in the elderly and comorbid populations.

Nephron-sparing management vs radical nephroureterectomy for low- or moderate-grade, low-stage upper tract urothelial carcinoma.

OBJECTIVE: To compare overall and cancer-specific outcomes between patients with upper tract urothelial carcinoma (UTUC) managed with either radical nephroureterectomy (RNU) or nephron-sparing measures (NSM) using a large population-based dataset. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results (SEER) data, patients diagnosed with low- or moderate-grade, localised non-invasive UTUC were stratified into two groups: those treated with RNU or NSM (observation, endoscopic ablation, or segmental ureterectomy). Cancer-specific mortality (CSM) and other-cause mortality (OCM) rates were determined using cumulative incidence estimators. Adjusting for clinical and pathological characteristics, the associations between surgical type, all-cause mortality and CSM were tested using Cox regressions and Fine and Gray regressions, respectively. RESULTS: Of 1227 patients [mean (sd) age 70.2 (11.00) years, 63.2% male] meeting inclusion criteria, 907 (73.9%) and 320 (26.1%) patients underwent RNU and NSM for low- or moderate-grade, low-stage UTUC from 1992 to 2008. Patients undergoing NSM were older (mean age 71.6 vs 69.7 years, P < 0.01) with a greater proportion of well-differentiated tumours (26.3% vs 18.0%, P = 0.001). While there were differences in OCM between the groups (P < 0.01), CSM trends were equivalent. After adjustment, RNU treatment was associated with improved non-cancer cause survival [hazard ratio (HR) 0.78, confidence interval [CI] 0.64-0.94) while no association with CSM was demonstrable (HR 0.89, CI 0.63-1.26). CONCLUSIONS: Patients with low- or moderate-grade, low-stage UTUC managed through NSM are older and are more likely to die of other causes, but they have similar CSM rates to those patients managed with RNU. These data may be useful when counselling patients with UTUC with significant competing comorbidities.

Vesicocutaneous fistula at site of closed suprapubic tube tract as the first presenting sign of giant bladder stone.

Bladder stones represent approximately 5% of all cases of urolithiasis and are typically identified and managed long before causing irreversible renal injury. We present a case of a man in his 40s with a prior history of a gunshot wound to the abdomen who presented with leakage from a previously healed suprapubic tube tract and was found to have a giant bladder stone with a resulting renal injury. He subsequently underwent a combined open cystolithotomy and vesicocutaneous fistulotomy during his hospitalisation, which helped to improve his renal function. In addition to there being few reported cases of bladder stones >10 cm, this represents the first report in the literature of an associated decompressive 'pop-off' mechanism through a fistulised tract.

Appropriateness of Imaging for Low-Risk Prostate Cancer-Real World Data from the Pennsylvania Urologic Regional Collaboration (PURC).

Imaging for prostate cancer defines the extent of disease. Guidelines recommend against imaging low-risk prostate cancer patients with a computed tomography (CT) scan or bone scan due to the low probability of metastasis. We reviewed imaging performed for men diagnosed with low-risk prostate cancer across the Pennsylvania Urologic Regional Collaborative (PURC), a physician-led data sharing and quality improvement collaborative. The data of 10 practices were queried regarding the imaging performed in men diagnosed with prostate cancer from 2015 to 2022. The cohort included 13,122 patients with 3502 (27%) low-risk, 2364 (18%) favorable intermediate-risk, 3585 (27%) unfavorable intermediate-risk, and 3671 (28%) high-risk prostate cancer, based on the AUA guidelines. Amongst the low-risk patients, imaging utilization included pelvic MRI (59.7%), bone scan (17.8%), CT (16.0%), and PET-based imaging (0.5%). Redundant imaging occurred in 1022 patients (29.2%). There was variability among the PURC sites for imaging used in the low-risk patients, and iterative education reduced the need for CT and bone scans. Approximately 15% of low-risk patients had staging imaging performed using either a CT or bone scan, and redundant imaging occurred in almost one-third of men. Such data underscore the need for continued guideline-based education to optimize the stewardship of resources and reduce unnecessary costs to the healthcare system.

Current Perceptions, Practice Patterns, and Barriers to Adoption of Transperineal Prostate Biopsy Under Local Anesthesia.

OBJECTIVE: To assess perceptions, practice patterns, and barriers to adoption of transperineal prostate biopsy (TPBx) under local anesthesia. METHODS: Providers from Michigan urological surgery improvement collaborative (MUSIC) and Pennsylvania urologic regional collaborative (PURC) were administered an online survey to assess beliefs and educational needs regarding TPBx. Providers were divided into those who performed or did not perform TPBx. The MUSIC and PURC registries were queried to assess TPBx utilization. Descriptive analytics and bivariate analysis determined associations between provider/practice demographics and attitudes. RESULTS: Since 2019, TPBx adoption has increased more than 2-fold to 7.0% and 16% across MUSIC and PURC practices, respectively. Of 350 urologists invited to participate in a survey, a total of 91 complete responses were obtained with 21 respondents (23%) reported performing TPBx. Participants estimated the learning curve was <10 procedure for TPBx performers and non-performers. No significant association was observed between learning curve and provider age/practice setting. The major perceived benefits of TPBx were decreased risk of sepsis, improved cancer detection rate and antibiotic stewardship. The most commonly cited challenges to implementation included access to equipment and patient experience. Urologists performing TPBx reported learning curve as an additional barrier, while those not performing TPBx reported duration of procedure. CONCLUSION: Access to equipment and patient experience concerns remain substantial barriers to adoption of TPBx. Dissemination of techniques utilizing existing equipment and optimization of local anesthetic protocols for TPBx may help facilitate the continued adoption of TPBx.

Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates.

PURPOSE: There is significant interest in identifying complete responders to neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) to potentially avoid removal of a pathologically benign bladder. However, clinical restaging after NAC is highly inaccurate. The objective of this study was to develop a next-generation sequencing-based molecular assay using urine to enhance clinical staging of patients with bladder cancer. METHODS: Urine samples from 20 and 44 patients with bladder cancer undergoing RC were prospectively collected for retrospective analysis for molecular correlate analysis from two clinical trials, respectively. The first cohort was used to benchmark the assay, and the second was used to determine the performance characteristics of the test as it correlates to responder status as measured by pathologic examination. RESULTS: First, to benchmark the assay, known mutations identified in the tissue (MT) of patients from the Accelerated Methotrexate, Vinblastine, Doxorubicin, Cisplatin trial (ClinicalTrials.gov identifier: NCT01611662, n = 16) and a cohort from University of California-San Francisco (n = 4) were cross referenced against mutation profiles from urine (MU). We then determined the correlation between MU persistence and residual disease in pre-RC urine samples from a second prospective clinical trial (The pT0 trial; ClinicalTrials.gov identifier: NCT02968732). Residual MU status correlated strongly with residual disease status (pT0 trial; n = 44; P = .0092) when MU from urine supernatant and urine pellet were assessed separately and analyzed in tandem. The sensitivity, specificity, PPV, and NPV were 91%, 50%, 86%, and 63% respectively, with an overall accuracy of 82% for this second cohort. CONCLUSION: MU are representative of MT and thus can be used to enhance clinical staging of urothelial carcinoma. Urine biopsy may be used as a reliable tool that can be further developed to identify complete response to NAC in anticipation of safe RC avoidance.

Familiarity and self-reported compliance with American Urological Association best practice recommendations for use of thromboembolic prophylaxis among American Urological Association members.

PURPOSE: Thromboprophylaxis with subcutaneous heparin or low molecular weight heparin is now an integral part of national surgical quality and safety assessment efforts, and has been incorporated into the current AUA Best Practice Statement. We evaluated familiarity and compliance with the AUA Best Practice Statement, assessed practice patterns in terms of perioperative thromboprophylaxis and specifically examined self-reported compliance in high risk patients undergoing radical cystectomy. MATERIALS AND METHODS: An electronic survey was sent to AUA members with valid e-mail addresses (10,966). Associations between AUA Best Practice Statement adherence and factors such as urological specialty, graduation year and guideline familiarity were assessed using chi-square analyses and generalized estimating equations. RESULTS: With 1,210 survey responses the largest group of respondents was urological oncologists and/or laparoscopic/robotic specialists (26.0%). This group was more likely to use thromboprophylaxis than nonurological oncologists and/or laparoscopic/robotic specialists in high risk patients (OR 1.3, CI 1.1-1.5). Respondents aware of the AUA Best Practice Statement guidelines (50.7%) were more likely to use thromboprophylaxis (OR 1.4, CI 1.2-1.6). Although 18.1% of urological oncologists and/or laparoscopic/robotic specialists and 34.2% of nonurological oncologists and/or laparoscopic/robotic specialists avoided routine thromboprophylaxis in patients undergoing radical cystectomy, the former were more likely to use thromboprophylaxis (p <0.0001) than other respondents. Urologists graduating after the year 2000 used thromboprophylaxis in high risk patients undergoing radical cystectomy more often than did earlier graduates (79.2% vs 63.4%, p <0.0001). CONCLUSIONS: Although younger age and self-reported urological oncologist and/or laparoscopic/robotic specialist status correlated strongly with thromboprophylaxis use, self-reported adherence to AUA Best Practice Statement was low, even in high risk cases with clear AUA Best Practice Statement recommendations such as radical cystectomy. These data identify opportunities for quality improvement in patients undergoing major urological surgery.

Comparison of prostate cancer diagnosis in patients receiving unrelated urological and non-urological cancer care.

OBJECTIVE: To evaluate prostate cancer diagnosis rates and survival outcomes in patients receiving unrelated (non-prostate) urological care with those in patients receiving non-urological care. MATERIALS AND METHODS: We conducted a population-based study using the Surveillance Epidemiology and End Results (SEER) database to identify men who underwent surgical treatment of renal cell carcinoma (RCC; n = 18,188) and colorectal carcinoma (CRC; n = 45,093) between 1992 and 2008. Using SEER*stat software to estimate standardized incidence ratios (SIRs), we investigated rates of prostate cancer diagnosis in patients with RCC and patients with CRC. Adjusting for patient age, race and year of diagnosis on multivariate analysis, we used Cox and Fine and Gray proportional hazards regressions to evaluate overall and disease-specific survival endpoints. RESULTS: The observed incidence of prostate cancer was higher in both the patients with RCC and those with CRC: SIR = 1.36 (95% confidence interval [CI] 1.27-1.46) vs 1.06 (95% CI 1.02-1.11). Adjusted prostate cancer SIRs were 30% higher (P < 0.001) in patients with RCC. Overall (hazard ratio = 1.13, P < 0.001) and primary cancer-adjusted mortalities (sub-distribution Hazard Ratio (sHR) = 1.17, P < 0.001) were higher in patients with RCC with no significant difference in prostate cancer-specific mortality (sHR = 0.827, P = 0.391). CONCLUSION: Rates of prostate cancer diagnosis were higher in patients with RCC (a cohort with unrelated urological cancer care) than in those with CRC. Despite higher overall mortality in patients with RCC, prostate cancer-specific survival was similar in both groups. Opportunities may exist to better target prostate cancer screening in patients who receive non-prostate-related urological care. Furthermore, urologists should not feel obligated to perform prostate-specific antigen screening for all patients receiving non-prostate-related urological care.

Model risk scores may underestimate rate of biochemical recurrence in African American men with localized prostate cancer: a cohort analysis of over 3000 men.

INTRODUCTION: This study aims to determine if there is a difference in prostate cancer nomogram-adjusted risk of biochemical recurrence (BCR) and/or adverse pathology (AP) between African American (AAM) and Caucasian men (CM) undergoing radical prostatectomy (RP). METHODS: A retrospective review was performed of men undergoing RP in the Pennsylvania Urologic Regional Collaborative between 2015 and 2021. Cox proportional hazard regression models were used to compare the rate of BCR after RP, and logistic regression models were used to compare rates of AP after RP between CM and AAM, adjusting for the CAPRA, CAPRA-S, and MSKCC pre- and post-operative nomogram scores. RESULTS: Rates of BCR and AP after RP were analyzed from 3190 and 5029 men meeting inclusion criteria, respectively. The 2-year BCR-free survival was lower in AAM (72.5%) compared to CM (79.0%), with a hazard ratio (HR) of 1.38 (95% CI 1.16-1.63, p < 0.001). The rate of BCR was significantly greater in AAM compared to CM after adjustment for MSKCC pre-op (HR 1.29; 95% CI 1.08-1.53; p = 0.004), and post-op nomograms (HR 1.26; 95% CI 1.05-1.49; p < 0.001). There was a trend toward higher BCR rates among AAM after adjustment for CAPRA (HR 1.13; 95% CI 0.95-1.35; p = 0.17) and CAPRA-S nomograms (HR 1.11; 95% 0.93-1.32; p = 0.25), which did not reach statistical significance. The rate of AP was significantly greater in AAM compared to CM after adjusting for CAPRA (OR 1.28; 95% CI 1.10-1.50; p = 0.001) and MSKCC nomograms (OR 1.23; 95% CI 1.06-1.43; p = 0.007). CONCLUSION: This analysis of a large multicenter cohort provides further evidence that AAM may have higher rates of BCR and AP after RP than is predicted by CAPRA and MSKCC nomograms. Accordingly, AAM may benefit with closer post-operative surveillance and may be more likely to require salvage therapies.

Multiparametric MRI is not sufficient for prostate cancer staging: A single institutional experience validated by a multi-institutional regional collaborative.

OBJECTIVE: Multiparametric magnetic resonance imaging (mpMRI) has been increasingly utilized in prostate cancer (CaP) diagnosis and staging. While Level 1 data supports MRI utility in CaP diagnosis, there is less data on staging utility. We sought to evaluate the real-world accuracy of mpMRI in staging localized CaP. MATERIALS AND METHODS: Men who underwent radical prostatectomy (RP) for CaP in 2021 at our institution were identified. Sensitivity, specificity, positive predictive value and negative predictive value of mpMRI in predicting pT2N0 organ confined disease , extracapsular extension , seminal vesicle invasion , lymph node involvement, and bladder neck invasion were evaluated. Associations between MRI accuracy and AUA risk stratification (AUA RS), MRI institution (MRI-I), MRI strength (1.5 vs. 3T) (MRI-S), and MRI timing (MRI-T) were assessed. These analyses were repeated using Pennsylvania Urologic Regional Collaborative (PURC) data. RESULTS: Institutional and community mpMRI CaP staging data demonstrated poor sensitivity (2.9%-49.2%% vs. 16.8%-24.4%), positive predictive value (40%-100% vs. 35.8%-68.2%), and negative predictive value (56.3%-94.3% vs. 68.4%-96.2%) in predicting surgical pathologic features - in contrast, specificity (89.1%-100% vs. 93.9%-98.6%) was adequate. mpMRI accuracy for extracapsular extension, seminal vesicle invasion, and lymph node involvement was significantly (p < 0.001) associated with AUA RS. There was no association between mpMRI accuracy and MRI-I, MRI-S, and MRI-T. CONCLUSION: Despite enthusiasm for its use, in a real-world setting, mpMRI appears to be a poor staging study for localized CaP and is unreliable as the sole means of staging patients prior to prostatectomy. mpMRI should be used cautiously as a staging tool for CaP, and should be interpreted considering individual patient risk strata.

Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications.

INTRODUCTION: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer. METHODS AND ANALYSIS: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer. ETHICS AND DISSEMINATION: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT04815876.

The role of minimally invasive surgery in multifocal renal cell carcinoma.

Surgical excision remains the reference standard for treatment of localized renal cell carcinoma (RCC). Laparoscopic and robotic minimally invasive extirpative approaches are being increasingly employed in current urologic practice. Multiple tumors in the same kidney present a unique set of challenges for minimally invasive surgeons. As such, we review recent literature regarding minimally invasive nephron-sparing surgery in patients with synchronous, ipsilateral, multifocal renal tumors. As the experience with these complex operations grows, perioperative, short-term functional and oncologic outcomes appear comparable to traditional open nephron-sparing surgery. Data on surgical approaches to patients with synchronous, ipsilateral, multifocal RCC are emerging. Short-term results suggest minimally invasive nephron-sparing surgery is safe, feasible, and should be considered as a potential treatment option for patients who present with multiple tumors in the same renal unit.

Prostate cancer biochemical recurrence rates after robotic-assisted laparoscopic radical prostatectomy.

BACKGROUND AND OBJECTIVES: To determine prostate cancer biochemical recurrence rates with respect to surgical margin (SM) status for patients undergoing robotic-assisted laparoscopic radical prostatectomy (RALP). METHODS: IRB-approved radical prostatectomy database was queried. Patients were stratified as low, intermediate, and high risk according to D'Amico's risk classification. Postoperative prostate-specific antigen (PSA) values were obtained every 3 mo for the first year, then biannually and annually thereafter. Biochemical recurrence was defined as ≥0.2ng/mL. Patients receiving adjuvant or salvage treatment were included. Positive surgical margin was defined as presence of cancer cells at inked resection margin in the final specimen. Margin presence (negative/positive), margin multiplicity (single/multiple), and margin length (≤ 3mm focal and >3mm extensive) were noted. Kaplan-Meier curves of biochemical recurrence-free survival (BRFS) as a function of SM were generated. Forward stepwise multivariate Cox regression was performed, with preoperative PSA, Gleason score, pathologic stage, prostate gland weight, and SM as covariates. RESULTS: At our institution, 1437 patients underwent RALP (2003-2009). Of these, 1159 had sufficient data and were included in our analysis. Mean follow-up was 16 mo. Kaplan-Meier curves demonstrated significant increase in BRFS in low-risk and intermediate-risk groups with negative SM. Overall BRFS at 5 y was 72%. Gleason score, pathologic stage, and SM status were significant prognostic factors in multivariate analysis. CONCLUSIONS: Negative surgical margins resulted in lower biochemical recurrence rates for low-risk and intermediate-risk groups. Multifocal and longer positive margins were associated with higher biochemical recurrence rates compared with unifocal and shorter positive margins. Documenting biochemical recurrence rates for RALP is important, because this treatment for localized prostate cancer is validated.

Perspectives on the Role of Biopsy for Management of T1 Renal Masses: Survey Results From Two Regional Quality Improvement Collaboratives.

OBJECTIVE: To understand perspectives on renal mass biopsy, a survey was distributed to urologists in the Michigan Urological Surgery Improvement Collaborative and Pennsylvania Urologic Regional Collaborative. Renal mass biopsy (RMB) may reduce treatment of benign renal neoplasms; however, utilization varies widely. MATERIALS AND METHODS: Michigan Urological Surgery Improvement Collaborative and Pennsylvania Urologic Regional Collaborative are two quality improvement collaboratives that include a "real-world" collection of urologists from academic- and community-based settings. A 12-item survey assessing current RMB utilization, patient- and tumor-specific factors, adverse events, impact on management, and simulated patient scenarios was distributed. Responses are reported using descriptive statistics. RESULTS: Many responders (n = 54) indicated using RMB in less than 25% of cT1a (59%) and cT1b (85%) tumors. The most important patient-specific factors on the decision to recommend RMB were possible metastasis to the kidney (94%), patient comorbidity as a risk factor for active treatment (89%), and patient age (81%). The most important tumor-specific factors were the presence of bilateral tumors (81%), tumor size (70%) and perceived potential of performing nephron-sparing surgery (67%). Ten responders (19%) noted barriers to RMB in their practice, 23 (43%) recalled experiences with complications or poor outcomes, and 43 (80%) reported experiences where the results of RMB altered management. When presented with simulated patients, few urologists (9%-20%) recommended RMB in younger patients with any sized mass. Recommendations varied based on patient age, comorbidity, and tumor size. CONCLUSION: Understanding perspectives on RMB usage is essential prior to implementing quality improvement efforts. Most urologists participating in two statewide collaboratives infrequently recommend RMB. Optimizing RMB utilization may help reduce unnecessary treatments.

Utility of PSA density in patients with PI-RADS 3 lesions across a large multi-institutional collaborative.

INTRODUCTION: Prostate MRI detecting PI-RADs = 3 lesions has low diagnostic utility for prostate malignancy. Use of PSA density has been suggested to further risk-stratify these men, to potentially avoid biopsies in favor of monitoring. We evaluate the ability of PSA density (PSAd) to risk-stratify PIRADs 3 lesions across patients who underwent a prostate biopsy in a large multi-institutional collaborative. MATERIALS AND METHODS: Pennsylvania Urology Regional Collaborative (PURC) is a voluntary quality improvement collaborative of 11 academic and community urology practices in Pennsylvania and New Jersey. A retrospective analysis was performed on all patients in the PURC database that had a prostate MRI with PI-RADs 3 lesions only. PSA just before the MRI and prostate size reported on MRI were used to calculate the PSA. Clinicopathologic data were evaluated. Univariable analysis using Chi-Square and Kruskal Wallis tests and multivariable logistic regression were used to identify predictors of any PCa, and clinically significant prostate cancer (csPCa) was defined as ≥ Grade Group 2 (GG2.) RESULTS: Between May 2015 and March 2021, 349 patients with PIRADs 3 lesions only were identified and comprised the cohort of interest. Median PSA was 5.0 with a prostate volume of 58cc and a median PSA density of 0.11, 10.6% of the cohort was African American with 81.4% being Caucasian. Significant prostate cancer was detected in 70/349 (20.0%) men. Smaller prostate volume, abnormal DRE, and higher PSAd were significantly associated with clinically significant prostate cancer on univariable analysis. In men with PSAd <0.15, 31/228 (13.6%) harbored csPCa. Multivariable analysis confirmed that men with PSAd >0.15 were more likely to harbor clinically significant prostate cancer (P < 0.001). CONCLUSION: Across a large regional collaborative, patients with PIRADs 3 lesions on mpMRI were noted to have clinically significant cancer in 20% of biopsies. Using a PSA density cut-off of 0.15 may result in missing clinically significant prostate cancer in 13.6%. This information is useful for prebiopsy risk stratification and counseling.