A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial.

The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Recovery of Social Continence and Sexual Function in Men With High-risk Prostate Cancer After Radical Prostatectomy: Results From a Statewide Collaborative.

OBJECTIVES: To examine post-operative urinary and sexual functional outcomes for men with high-risk prostate cancer (HRPCa) who underwent radical prostatectomy (RP) within the Michigan Urological Surgery Improvement Collaborative (MUSIC). METHODS: We identified patients who underwent RP for HRPCa in MUSIC between 2014 and 2023. HRPCa was defined according to American Urological Association criteria. Patients completed Expanded Prostate Cancer Index Composite (EPIC-26) pre-RP and 3-, 6-, 12-, and 24-months postoperatively. Primary outcomes included social continence, defined as 0-1 pads used daily; and recovery of sexual function, defined as the ability to achieve erections firm enough for intercourse. Multivariable and bivariate analyses were performed to identify factors associated with recovery of social continence and sexual function. RESULTS: Around 1323 patients were included in the post-RP urinary continence analysis and 422 men in the sexual function analysis. Fifty-eight percent and 86% of patients achieved social continence at 3- and 12-months post-RP, respectively. Continence recovery was associated with higher baseline EPIC-26 urinary continence scores (OR 1.10, per 5 points, 95% CI 1.06-1.15, P <.001), and negatively associated with increasing age (OR 0.78 per 5-year increase, 95% CI 0.71-0.85 P <.001). Fifteen percent of patients had recovery of sexual function at 12-month post-RP. On bivariate analysis, recovery of sexual function was associated with nerve-sparing at time of RP, lower pre-operative PSA, and not receiving post-RP ADT/RT. CONCLUSION: RP for HRPCa has acceptable rates of postoperative social continence. However, post-RP recovery of sexual function remains a challenge. This information has important implications for pre-operative counseling and post-operative follow-up for patients with HRPCa.

Association of Baseline Magnetic Resonance Imaging Prostate Imaging Reporting and Data System Score With Prostate Cancer Active Surveillance Early Biopsy Reclassification: Data From the Michigan Urological Surgery Improvement Collaborative (MUSIC).

PURPOSE: The purpose of our study was to evaluate the association of baseline MRI Prostate Imaging Reporting and Data System (PI-RADS) score with biopsy reclassification in a multicenter active surveillance (AS) cohort. MATERIALS AND METHODS: We identified men in the Michigan Urological Surgery Improvement Collaborative registry (46 hospital-based/academic/private practice urology groups) with National Comprehensive Cancer Network (NCCN) low-risk and favorable intermediate-risk prostate cancer who underwent MRI within 6 months before or after initial biopsy and enrolled in AS from June 2016 to January 2021. The primary objective was to determine the association of baseline MRI PI-RADS score (≥4 lesion) with reclassification to high-grade prostate cancer (≥grade group 3) on surveillance biopsy. Multivariable Cox proportional hazards regression models were constructed and adjusted for pathologic, MRI, and clinical/biopsy factors, with landmark time of 6 months from diagnostic biopsy. We included an interaction term between PI-RADS score and NCCN group in the Cox model. RESULTS: A total of 1491 men were included with median age 64 years (IQR: 59-69) with median follow-up 11.0 months (IQR: 6.0-23.0) after landmark. Baseline PI-RADS ≥ 4 lesion was associated with an increased hazard of biopsy reclassification (HR: 2.3 [95% CI: 1.6-3.2], P < .001), along with grade group 2 vs 1 (HR: 2.5 [95% CI: 1.7-3.7], P < .001), and increasing age (per 10 years; HR: 1.8 [95% CI: 1.4-2.4], P < .001). The interaction between NCCN risk group with MRI findings was not significant (P = .7). CONCLUSIONS: In this multicenter cohort study of real-world data, baseline MRI PI-RADS score was significantly associated with early biopsy reclassification in men undergoing AS with NCCN low- or favorable intermediate-risk prostate cancer.

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.

Gold nanoshells for prostate cancer treatment: evidence for deposition in abdominal organs.

PURPOSE: Gold-silica nanoshell therapy [AuroShells with subsequent focal laser therapy (AuroLase)] is an emerging targeted treatment modality for prostate cancer. We reviewed pre- and post-treatment unenhanced CT imaging to assess for retained gold-silica nanoshells in the abdomen and pelvis. METHODS: This single-institution retrospective study identified patients in the AuroLase pilot who underwent pre- and post-treatment unenhanced abdominopelvic CT. The attenuation, before and after gold-silica nanoshell administration, of the liver, spleen, pancreas, kidneys, prostate, blood pool, paraspinal musculature, and abnormal lymph nodes were manually measured by two readers. After inter-reader agreement was calculated using intraclass correlation (ICC), a permutation test was used to assess pre- and post-therapy attenuation differences. RESULTS: Four patients met the inclusion criteria. Mean age was 72.3 ± 5.9 years. Median time interval between pre-treatment CT and treatment, and between treatment and post-treatment CT, was 232 days and 236.5 days, respectively. The two readers' attenuation measurements had very high agreement (ICC = 0.99, p < 0.001). The highest differences in organ attenuation between pre- and post-therapy scans were seen in all four patients in the liver and spleen (liver increased by an average of 28.9 HU, p = 0.010; spleen increased by an average of 63.7 HU, p = 0.012). A single measured lymph node increased by an average of 58.9 HU. In the remainder of the measured sites, the change in attenuation from pre- to post-therapy scans ranged from -0.1 to 3.8 HU (p > 0.05). CONCLUSION: Increased attenuation of liver and spleen at CT can be an expected finding in patients who have received gold-silica nanoshell therapy.

Does Urologist-level Utilization of Active Surveillance for Low-risk Prostate Cancer Correspond with Utilization of Active Surveillance for Small Renal Masses?

Active surveillance (AS) for prostate cancer (CaP) or small renal masses (SRMs) helps in limiting the overtreatment of indolent malignancies. Implementation of AS for these conditions varies substantially across individual urologists. We examined the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry to assess for correlation of AS between patients with low-risk CaP and patients with SRM managed by individual urologists. We identified 27 urologists who treated at least ten patients with National Comprehensive Cancer Network low-risk CaP and ten patients with SRMs between 2017 and 2021. For surgeons in the lowest quartile of AS use for low-risk CaP (<74%), 21% of their patients with SRMs were managed with AS, in comparison to 74% of patients of surgeons in the highest quartile (>90%). There was a modest positive correlation between the surgeon-level risk-adjusted proportions of patients managed with AS for low-risk CaP and for SRMs (Pearson correlation coefficient 0.48). A surgeon's tendency to use AS to manage one low-risk malignancy corresponds to their use of AS for a second low-risk condition. By identifying and correcting structural issues associated with underutilization of AS, interventions aimed at increasing AS use may have effects that influence clinical tendencies across a variety of urologic conditions. PATIENT SUMMARY: The use of active surveillance (AS) for patients with low-risk prostate cancer or small kidney masses varies greatly among individual urologists. Urologists who use AS for low-risk prostate cancer were more likely to use AS for patients with small kidney masses, but there is room to improve the use of AS for both of these conditions.

Can MRI Help Inform Which Men With a History of Multifocal High-Grade Prostatic Intraepithelial Neoplasia or Atypical Small Acinar Proliferation Remain at an Elevated Risk for Clinically Significant Prostate Cancer?

PURPOSE: We investigated the association of MRI findings in men with a previous diagnosis of atypical small acinar proliferation (ASAP) or multifocal high-grade intraepithelial neoplasia (HGPIN) with pathologic findings on repeat biopsy. MATERIALS AND METHODS: We retrospectively reviewed patients with ASAP/multifocal HGPIN undergoing a repeat biopsy in the Michigan Urological Surgery Improvement Collaborative registry. We included men with and without an MRI after the index biopsy demonstrating ASAP/multifocal HGPIN but before the repeat biopsy. Men with an MRI prior to the index biopsy were excluded. We compared the proportion of men with ≥ GG2 CaP (Grade Group 2 prostate cancer) on repeat biopsy among the following groups with the χ2 test: no MRI, PIRADS (Prostate Imaging-Reporting and Data System) ≥ 4, and PIRADS ≤ 3. Multivariable models were used to estimate the adjusted association between MRI findings and ≥ GG2 CaP on repeat biopsy. RESULTS: Among the 207 men with a previous diagnosis of ASAP/multifocal HGPIN that underwent a repeat biopsy, men with a PIRADS ≥ 4 lesion had a higher proportion of ≥ GG2 CaP (56%) compared with men without an MRI (12%, P < .001). A lower proportion of men with PIRADS ≤ 3 lesions had ≥ GG2 CaP (3.0%) compared with men without an MRI (12%, P = .13). In the adjusted model, men with a PIRADS 4 to 5 lesion had higher odds (OR: 11.4, P < .001) of ≥ GG2 CaP on repeat biopsy. CONCLUSIONS: MRI is a valuable diagnostic tool to triage which men with a history of ASAP or multifocal HGPIN on initial biopsy should undergo or avoid repeat biopsy without missing clinically significant CaP.

Scrotal calciphylaxis in a fifty-one-year-old man with end-stage renal disease and prior bacteremia.

Isolated, ischemic scrotal lesions are an uncommon manifestation of systemic calciphylaxis. This highly morbid disease seen in patients with end-stage renal disease and other risk factors for small vessel calcification results in tissue necrosis and ulceration. Scrotal calciphylaxis is uncommon and difficult to diagnose in patients with comorbid conditions that cause isolated genital skin lesions, including prior systemic infections. We describe a 51-year-old male with end-stage renal disease on hemodialysis and recent history of bacteremia who developed isolated penile and scrotal ulceration due to calciphylaxis. The patient died two months after presentation despite multidisciplinary care.

Comparing Patient-reported Functional Outcomes After Radical Prostatectomy in Historical and Contemporary Practice.

PURPOSE: Modifications to surgical technique, particularly the widespread adoption of robotic surgery, have been proposed to improve functional recovery after prostate cancer surgery. However, rigorous comparison of men in historical vs contemporary practice to evaluate the cumulative effect of these changes on urinary and sexual function after radical prostatectomy is lacking. MATERIALS AND METHODS: We compared prospectively collected patient-reported urinary and sexual function from historical (PROSTQA [Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment study], n=235) and contemporary (MUSIC-PRO [Michigan Urological Surgery Improvement Collaborative Patient Reported Outcome] registry, n=1,215) cohorts at the University of Michigan to understand whether modern techniques have resulted in functional improvements for men undergoing prostate cancer surgery. RESULTS: We found significant differences in baseline function, with better urinary (median [IQR]; 100 [93.8-100] vs 93.8 [85.5-100], P < .001) and sexual scores (median [IQR]; 83.3 [66.7-100] vs 74.4 [44.2-87.5], P < .001) prior to treatment in PROSTQA compared to MUSIC-PRO patients, respectively. There was no statistically significant difference in the pattern of urinary incontinence recovery after surgery from 6-24 months between groups (P = .14). However, men in the contemporary MUSIC-PRO group did have significantly better recovery of sexual function compared to men in the historical PROSTQA group (P < .0001). Further, we found that contemporary practice consists of men with more unfavorable demographic and clinical characteristics compared to historical practice. CONCLUSIONS: Our results demonstrate that the widespread alterations in prostate cancer surgery over the past 2 decades have yielded improvements in sexual, but not urinary, function recovery.

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.

Upgrading on Per Protocol versus For Cause surveillance prostate biopsies: An opportunity to decreasing the burden of active surveillance.

BACKGROUND: Most prostate cancer (PC) active surveillance (AS) protocols recommend "Per Protocol" surveillance biopsy (PPSBx) every 1-3 years, even if clinical and imaging parameters remained stable. Herein, we compared the incidence of upgrading on biopsies that met criteria for "For Cause" surveillance biopsy (FCSBx) versus PPSBx. METHODS: We retrospectively reviewed men with GG1 PC on AS in the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry. Surveillance prostate biopsies obtained 1 year after diagnosis were classified as either PPSBx or FCSBx. Biopsies were retrospectively deemed FCSBx if any of these criteria were met: PSA velocity > 0.75 ng/mL/year; rise in PSA > 3 ng from baseline; surveillance magnetic resonance imaging (MRI) (sMRI) with a PIRADS ≥ 4; change in DRE. Biopsies were classified PPSBx if none of these criteria were met. The primary outcome was upgrading to ≥GG2 or ≥GG3 on surveillance biopsy. The secondary objective was to assess for the association of reassuring (PIRADS ≤ 3) confirmatory or surveillance MRI findings and upgrading for patients undergoing PPSBx. Proportions were compared with the chi-squared test. RESULTS: We identified 1773 men with GG1 PC in MUSIC who underwent a surveillance biopsy. Men meeting criteria for FCSBx had more upgrading to ≥GG2 (45%) and ≥GG3 (12%) compared with those meeting criteria for PPSBx (26% and 4.9%, respectively, p < 0.001 and p < 0.001). Men with a reassuring confirmatory or surveillance MRI undergoing PPSBx had less upgrading to ≥GG2 (17% and 17%, respectively) and ≥GG3 (2.9% and 1.8%, respectively) disease compared with men without an MRI (31% and 7.4%, respectively). CONCLUSIONS: Patients undergoing PPSBx had significantly less upgrading compared with men undergoing FCSBx. Confirmatory and surveillance MRI seem to be valuable tools to stratify the intensity of surveillance biopsies for men on AS. These data may help inform the development of a risk-stratified, data driven AS protocol.

Development and Validation of a Model to Predict Ureteral Stent Placement Following Ureteroscopy: Results From a Statewide Collaborative.

OBJECTIVE: To develop and validate a model to predict whether patients undergoing ureteroscopy (URS) will receive a stent. METHODS: Using registry data obtained from the Michigan Urological Surgery Improvement Collaborative Reducing Operative Complications from Kidney Stones initiative, we identified patients undergoing URS from 2016 to 2020. We used patients' age, sex, body mass index, size and location of the largest stone, current stent in place, history of any kidney stone procedure, procedure type, and acuity to fit a multivariable logistic regression model to a derivation cohort consisting of a random two-thirds of episodes. Model discrimination and calibration were evaluated in the validation cohort. A sensitivity analysis examined urologist variation using generalized mixed-effect models. RESULTS: We identified 15,048 URS procedures, of which 11,471 (76%) had ureteral stents placed. Older age, male sex, larger stone size, the largest stone being in the ureteropelvic junction, no prior stone surgery, no stent in place, a planned procedure type of laser lithotripsy, and urgent procedure were associated with a higher risk of stent placement. The model achieved an area under the receiver operating characteristic curve of 0.69 (95% CI 0.67, 0.71). Incorporating urologist-level variation improved the area under the receiver operating characteristic curve to 0.83 (95% CI 0.82, 0.84). CONCLUSION: Using a large clinical registry, we developed a multivariable regression model to predict ureteral stent placement following URS. Though well-calibrated, the model had modest discrimination due to heterogeneity in practice patterns in stent placement across urologists.

Intra-practice Urologist-level Variation in Targeted Fusion Biopsy Outcomes.

OBJECTIVE: To examine the extent to which the urologist performing biopsy contributes to variation in prostate cancer detection during fusion-guided prostate biopsy. METHODS: All men in the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry who underwent fusion biopsy at Michigan Medicine from August 2017 to March 2019 were included. The primary outcomes were clinically significant cancer detection rate (defined as Gleason Grade ≥2) in targeted cores and clinically significant cancer detection on targeted cores stratified by PI-RADS score. Bivariate and multivariable logistic regression analyses were performed. RESULTS: A total of 1133 fusion biopsies performed by 5 providers were included. When adjusting for patient age, PSA, race, family history, prostate volume, clinical stage, and PI-RADS score, there was no significant difference in targeted clinically significant cancer detection rates across providers (range = 38.5%-46.9%, adjusted P-value = .575). Clinically significant cancer detection rates ranged from 11.1% to 16.7% in PI-RADS 3 (unadjusted P = .838), from 24.6% to 43.4% in PI-RADS 4 (adjusted P = .003), and from 69.4% to 78.8% in PI-RADS 5 (adjusted P = .766) lesions. CONCLUSION: There was a statistically significant difference in clinically significant prostate cancer detection in PI-RADS 4 lesions across providers. These findings suggest that even among experienced providers, variation at the urologist level may contribute to differences in clinically significant cancer detection rates within PI-RADS 4 lesions. However, the relative impact of biopsy technique, radiologist interpretation, and MR acquisition protocol requires further study.

Contemporary patterns of local ablative therapies for prostate cancer at United States cancer centers: results from a national registry.

PURPOSE: To describe the national-level patterns of care for local ablative therapy among men with PCa and identify patient- and hospital-level factors associated with the receipt of these techniques. METHODS: We retrospectively interrogated the National Cancer Database (NCDB) for men with clinically localized PCa between 2010 and 2017. The main outcome was receipt of local tumor ablation with either cryo- or laser-ablation, and "other method of local tumor destruction including high-intensity focused ultrasound (HIFU)". Patient level, hospital level, and demographic variables were collected. Mixed effect logistic regression models were fitted to identify separately patient- and hospital-level predictors of receipt of local ablative therapy. RESULTS: Overall, 11,278 patients received ablative therapy, of whom 78.8% had cryotherapy, 15.6% had laser, and 5.7% had another method including HIFU. At the patient level, men with intermediate-risk PCa were more likely to be treated with local ablative therapy (OR 1.05; 95% CI 1.00-1.11; p = 0.05), as were men with Charlson Comorbidity Index > 1 (OR 1.36; 95% CI 1.29-1.43; p < 0.01), men between 71 and 80 years (OR 3.70; 95% CI 3.43-3.99; p < 0.01), men with Medicare insurance (OR 1.38; 95% 1.31-1.46; p < 0.01), and an income < $47,999 (OR 1.16; 95% CI 1.06-1.21; p < 0.01). At the hospital-level, local ablative therapy was less likely to be performed in academic/research facilities (OR 0.45; 95% CI 0.32-0.64; p < 0.01). CONCLUSIONS: Local ablative therapy for PCa treatment is more commonly offered among older and comorbid patients. Future studies should investigate the uptake of these technologies in non-hospital-based settings and in light of recent changes in insurance coverage.

The Impact of a Statewide Active Surveillance Initiative: A Roadmap for Increasing Active Surveillance Utilization Nationwide.

Active surveillance (AS) is recommended as a management option for men with favorable-risk (low risk and favorable intermediate risk) prostate cancer; however, national rates remain low. The Michigan Urological Surgery Improvement Collaborative (MUSIC) established a quality improvement (QI) initiative in June 2014 to increase AS utilization. In this report, we analyze the rates of AS utilization over time in the state of Michigan (MUSIC) for men with favorable-risk prostate cancer and compare these to rates for other men diagnosed with favorable-risk prostate cancer in the USA outside the state of Michigan. While the variables that influence AS utilization were the same in both cohorts, we found that the AS utilization rates and the rate of increase were significantly higher in MUSIC. We conclude that the QI initiative started in MUSIC should serve as a roadmap to increasing AS use nationwide. PATIENT SUMMARY: Active surveillance (AS), which involves close monitoring with blood tests and scans, is recommended for management of favorable-risk prostate cancer to avoid or delay unnecessary treatment. Our results show that a quality improvement program in Michigan increased AS use for prostate cancer patients in the state. This program should be used to increase AS uptake throughout the USA.

Should Transperineal Prostate Biopsy Be the Standard of Care?

PURPOSE OF REVIEW: We reviewed the advantages and disadvantages of transperineal prostate biopsy (TP-bx) to evaluate its potential role as the standard of care for prostate biopsy. RECENT FINDINGS: Studies have suggested no difference in prostate cancer (PCa) detection rate between TP-bx and transrectal biopsy (TR-bx) but have suggested potentially increased detection of anterior prostate tumors. Advances in anesthetic technique have obviated the need for sedation thus allowing TP-bx to become an office-based procedure, which in turn can decrease the overall cost of TP-bx. Furthermore, given the low rate of infectious complications after TP-bx, some have foregone peri-procedural antibiotics without a change in the rate of infectious complications. Recent procedural advances have made TP-bx a tolerable, office-based procedure. Given the similar diagnostic performance and the benefits for the patient and community, TP-bx should become the standard of care for prostate biopsy for most patients. Future efforts should address the barriers for more universal adoption.

The Use and Short-term Outcomes of Active Surveillance in Men With National Comprehensive Cancer Network Favorable Intermediate-risk Prostate Cancer: The Initial Michigan Urological Surgery Improvement Collaborative Experience.

PURPOSE: National Comprehensive Cancer Network favorable intermediate-risk prostate cancer is a heterogeneous disease with varied oncologic and survival outcomes. We describe the Michigan Urological Surgery Improvement Collaborative's experience with the use of active surveillance and the short-term oncologic outcomes for men with favorable intermediate-risk prostate cancer.Materials and Methods:We reviewed the Michigan Urological Surgery Improvement Collaborative registry for men diagnosed with favorable intermediate-risk prostate cancer from 2012-2020. The proportion of men with favorable intermediate-risk prostate cancer managed with active surveillance was calculated by year of diagnosis. For men selecting active surveillance, the Kaplan-Meier method was used to estimate treatment-free survival. To assess for the oncologic safety of active surveillance, we compared the proportion of patients with adverse pathology and biochemical recurrence-free survival between men undergoing delayed radical prostatectomy after a period of active surveillance with men undergoing immediate radical prostatectomy. RESULTS: Of the 4,275 men with favorable intermediate-risk prostate cancer, 1,321 (31%) were managed with active surveillance, increasing from 13% in 2012 to 45% in 2020. The 5-year treatment-free probability for men with favorable intermediate-risk prostate cancer on active surveillance was 73% for Gleason Grade Group 1 and 57% for Grade Group 2 disease. More men undergoing a delayed radical prostatectomy had adverse pathology (46%) compared with immediate radical prostatectomy (32%, P < .001), yet short-term biochemical recurrence was similar between groups (log-rank test, P = .131). CONCLUSIONS: The use of active surveillance for men with favorable intermediate-risk prostate cancer has increased markedly. Over half of men with favorable intermediate-risk prostate cancer on active surveillance remained free of treatment 5 years after diagnosis. Most men on active surveillance will not lose their window of cure and have similar short-term oncologic outcomes as men undergoing up-front treatment. Active surveillance is an oncologically safe option for appropriately selected men with favorable intermediate-risk prostate cancer.

Less is More: Fulfillment of Opioid Prescriptions Before and After Implementation of a Modifier 22 Based Quality Incentive for Opioid-Free Vasectomies.

OBJECTIVE: To examine the percentage of patients who filled peri-procedural opioid prescriptions before and after Blue Cross Blue Shield of Michigan (BCBSM) launched a modifier 22 payment incentive for opioid-sparing vasectomies in Michigan on July 1, 2019. METHODS: We evaluated BCBSM administrative claims data from February 1, 2018 - November 16, 2020 for men 20 - 64 years old who underwent vasectomy or a control office-based urologic procedure (cystourethroscopy, prostate biopsy, circumcision, and transurethral destruction of prostate tissue.) The primary outcome was the percentage of patients who filled opioid prescriptions 30 days before to 3 days after their procedure. We performed an interrupted time series analysis to estimate changes in the percentage of patients who filled opioid prescriptions in the vasectomy and control group before and after July 1, 1019. RESULTS: Our cohort included 4,559 men who had a vasectomy and 4,679 men who had a control procedure. Within each group, demographics and clinical factors were similar before and after July 1, 2019. Before implementation of the modifier 22 policy, 32.5% of men who had a vasectomy filled an opioid prescription whereas only 12.6% of men filled an opioid prescription after July 1, 2019 -a 19.9% absolute reduction and 61.0% relative reduction (P < .001). In the control group, there was no significant change in the percentage of patients who filled opioid prescriptions before and after July 1, 2019 (0.8% absolute increase, P = .671). CONCLUSION: Implementation of modifier 22 based financial incentive for opioid-sparing vasectomies was associated with decrease in the percentage of men who filled opioid prescriptions after vasectomy.