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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., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Patients with lymph node positive (pN+) disease found at the time of radical prostatectomy with pelvic lymphadenectomy for clinically localized prostate cancer (CaP) are at high risk of disease persistence and progression. Contemporary management trends of pN+ CaP are not well described., Materials and Methods: Patients in the Michigan Urologic Surgery Improvement Collaborative (MUSIC) with clinically localized prostate cancer who underwent radical prostatectomy between 2012 and 2023 with cN0/pN+ disease were identified. The primary outcome was to evaluate patient and practice-level factors associated with time to secondary post-RP treatment. Secondary outcomes included practice-level variation in management of pN+ CaP and rates of secondary treatment modality. To assess factors associated with secondary treatment, a Cox proportional hazards model of a 60-day landmark analysis was performed., Results: We identified 666 patients with pN+ disease. Overall, 66% underwent secondary treatment within 12 months post-RP. About 19% of patients with detectable post-RP PSA did not receive treatment. Of patients receiving secondary treatment after 60-days post-RP, 34% received androgen deprivation therapy (ADT) alone, 27% received radiation (RT) alone, 36% received combination, and 4% received other systemic therapies. In the multivariable model, pathologic grade group (GG)3 (HR 1.5; 95%CI: 1.05-2.14), GG4-5 (HR 1.65; 95%CI: 1.16-2.34), positive margins (HR 1.46; 95%CI: 1.13-1.88), and detectable postoperative PSA ≥0.1 ng/ml (HR 3.46; 95%CI: 2.61-4.59) were significantly associated with secondary post-RP treatment. There was wide variation in adjusted practice-level 12-month secondary treatment utilization (28%-79%)., Conclusions: The majority pN+ patients receive treatment within 12 months post-RP which was associated with high-risk pathological features and post-RP PSA. Variation in management of pN+ disease highlights the uncertainty regarding the optimal management. Understanding which patients will benefit from secondary treatment, and which type, will be critical to minimize variation in care., Competing Interests: Declaration of competing interest Robert E. Dess – Jansen (Advisory Board). Todd Morgan – Tempus (Advisory Board), Myriad Genetics (Research Funding), Stratify Genomics (Advisory Board)., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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 χ 2 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.

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.

Objective: High-risk (HR) prostate cancer (CaP) patients are at greatest risk for occult metastases and disease progression. Radical prostatectomy (RP) provides benefit, but remains of unknown oncologic value compared with other options. We investigated outcomes of RP for HR, very-high-risk (VHR), or metastatic CaP., Methods: Included are 1,635 patients undergoing RP between January 2012 and December 2018 (prior to widespread availability of CaP-specific PET imaging). VHR CaP was defined as having ≥2HR features, >4cores of biopsy Gleason ≥4+4, or primary Gleason pattern 5. Metastatic CaP was defined by radiographic evidence of N1 and/or M1 CaP and grouped as cN1M any and cN0M1. Pre-treatment, perioperative, and early oncologic data were compared. Patient/tumor characteristics were compared according to risk groups using Chi-squared and Wilcoxon rank-sum tests. Kaplan-Meier analysis of cancer progression and multivariable analyses were performed., Results: Length of stay >2days and readmission following RP was 10.8% and 5.5% for patients with HR or higher CaP. Median time to progression was 3.9 months (IQR:1.6-13.9), and 2-year progression-free probability was 67% for HR, 53% for VHR, 51% for cN1M any , and 58% for cN0M1. In multivariable analysis, VHR (hazard ratio:1.70; P < 0.0001) and cN1M any (1.96, P < 0.0001) were highly significant predictors of progression, while cN0M1 was not (P = 0.54), compared with non-metastatic HR CaP. Limitations include selection biases and imprecision of imaging methodologies., Conclusions: Most patients with HR or higher CaP remain progression-free 2 years after RP, with acceptable perioperative outcomes. Progression-free survival was similar in cN1 and VHR patients, better with non-metastatic HR CaP, and between these for cN0M1 patients indicating the imprecise clinical staging occurring with conventional imaging modalities alone., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To assess which patients with intermediate-risk PCa would benefit from a pelvic lymph node dissection (PLND) across the Michigan Urological Surgery Improvement Collaborative, given the discrepancy in recommendations. AUA guidelines for localized prostate cancer (PCa) state that PLND is indicated for patients with unfavorable intermediate-risk and high-risk PCa and can be considered in favorable intermediate-risk patients. NCCN guidelines recommend PLND when risk for nodal disease is ≥2%., Methods: Data regarding all robot-assisted radical prostatectomy (RARP) (March 2012-October 2020) were prospectively collected, including patient, and surgeon characteristics. Univariate and multivariate analyses of PLND rate and lymph node involvement (LN+) were performed., Results: Among 8,591 men undergoing RARP for intermediate-risk PCa, 80.2% were performed with PLND (n = 6883), of which 2.9% were LN+ (n = 198). According to the current AUA risk stratification system, 1.2% of favorable intermediate-risk PCa and 4.7% of unfavorable intermediate-risk PCa demonstrated LN+. There were also differences in the LN+ rates among the subgroups of favorable (0.0%-1.3%), and unfavorable (3.5%-5.0%) categories. Additional factors associated with higher LN+ rates include ≥50% cores positive, ≥35% involvement at any core, and unfavorable genomic classifier result, none of which contribute to the favorable/unfavorable subgroups., Conclusion: These data support PLND at RARP for all patients with unfavorable intermediate-risk PCa. Our data also indicate patients with favorable intermediate-risk prostate cancer at greatest risk for LN+ are those with ≥50% cores positive, ≥35% involvement at any core, and/or unfavorable genomic classifier result., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To examine practice-level variation in the management of magnetic resonance imaging (MRI) Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions in men with favorable-risk prostate cancer (FRPC) considering or on active surveillance (AS)., Patients and Methods: We reviewed the Michigan Urological Surgery Improvement Collaborative registry for FRPC men (GG1 and low-volume GG2) undergoing MRI from January 2013 to March 2020. The primary outcome was to assess practice-level variation in time from MRI to biopsy and MRI to treatment for PI-RADS 3 lesions. Both MRIs obtained after the diagnostic biopsy and while on AS were included. The Kaplan-Meier method was used to estimate biopsy-free survival for time from MRI to surveillance biopsy and multivariable Cox proportional hazards models identified clinical and demographic factors associated with time obtaining a biopsy after finding PI-RADS 3 lesions., Results: We identified 3172 FRPC men with a MRI, of whom 473 had a PI-RADS 3. There was significant practice-level variation in biopsy rates among patients with PI-RADS 3 MRI results (log-rank test, P <.001), with biopsy-free probability at 6 months ranging from 28% to 69% (median: 59%). We were unable to identify factors with significant associations with time to biopsy. Conversely, there was less variation in time from PI-RADS 3 to treatment (log-rank test, P = .2), while several clinical factors had statistically-significant associations: age (P = .018), Prostate Specific Antigen-Density 0.1-0.2 (P = .035), ISUP-GG 2 (P = .002), and number of positive cores (P <.001), as expected., Conclusion: Urology practice, rather than GG or extent of biopsy positivity, is the largest factor affecting the decision for biopsy of PI-RADS 3 lesions in FRPC men considering or on AS. Future work to assist with decision-making and reduce variability is needed., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Purpose: Prediction models are recommended by national guidelines to support clinical decision making in prostate cancer. Existing models to predict pathological outcomes of radical prostatectomy (RP)-the Memorial Sloan Kettering (MSK) models, Partin tables, and the Briganti nomogram-have been developed using data from tertiary care centers and may not generalize well to other settings., Materials and Methods: Data from a regional cohort (Michigan Urological Surgery Improvement Collaborative [MUSIC]) were used to develop models to predict extraprostatic extension (EPE), seminal vesicle invasion (SVI), lymph node invasion (LNI), and nonorgan-confined disease (NOCD) in patients undergoing RP. The MUSIC models were compared against the MSK models, Partin tables, and Briganti nomogram (for LNI) using data from a national cohort (Surveillance, Epidemiology, and End Results [SEER] registry)., Results: We identified 7,491 eligible patients in the SEER registry. The MUSIC model had good discrimination (SEER AUC EPE: 0.77; SVI: 0.80; LNI: 0.83; NOCD: 0.77) and was well calibrated. While the MSK models had similar discrimination to the MUSIC models (SEER AUC EPE: 0.76; SVI: 0.80; LNI: 0.84; NOCD: 0.76), they overestimated the risk of EPE, LNI, and NOCD. The Partin tables had inferior discrimination (SEER AUC EPE: 0.67; SVI: 0.76; LNI: 0.69; NOCD: 0.72) as compared to other models. The Briganti LNI nomogram had an AUC of 0.81 in SEER but overestimated the risk., Conclusions: New models developed using the MUSIC registry outperformed existing models and should be considered as potential replacements for the prediction of pathological outcomes in prostate cancer.

Objectives: To examine the relationship between influential factors and treatment decisions among men with newly diagnosed prostate cancer (PCa)., Methods: We identified men in the Michigan Urological Surgery Improvement Collaborative registry diagnosed with localized PCa between 2018-2020 who completed Personal Patient Profile-Prostate. We analyzed the proportion of active surveillance (AS) between men who stated future bladder, bowel, and sexual problems (termed influential factors) had "a lot of influence" on their treatment decisions versus other responses. We also assessed the relationship between influential factors, confirmatory testing results and choice of AS., Results: A total of 509 men completed Personal Patient Profile-Prostate. Treatment decisions aligned with influential factors for 88% of men with favorable risk and 49% with unfavorable risk PCa. A higher proportion of men who identified bladder, bowel and sexual concerns as having "a lot of influence" on their treatment decision chose AS, compared with men with other influential factors, although not statistically significant (44% vs 35%, P = .11). Similar results were also found when men were stratified based on PCa risk groups (favorable risk: 78% vs 67%; unfavorable risk: 17% vs 9%, respectively). Despite a small sample size, a higher proportion of men with non-reassuring confirmatory testing selected AS if influential factors had "a lot of influence" compared to "no influence" on their treatment decisions., Conclusion: Men's concerns for future bladder, bowel, and sexual function problems, as elicited by a decision aid, may help explain treatment selection that differs from traditional clinical recommendation., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Holmium laser enucleation of the prostate (HoLEP) is effective in treating lower urinary tract symptoms from prostatic disease. We investigate the role of HoLEP in the management of patients with benign prostatic hypertrophy (BPH) and prostate cancer (CaP)., Methods: Retrospective review of data regarding all patients undergoing HoLEP at a single institution was performed. Pre- and postoperative PSA, multiparametric MRI, and pathology results were analyzed for those with CaP identified prior to or incidentally at HoLEP., Results: From February 2016 to February 2020, 201 patients underwent HoLEP. Twelve patients had CaP diagnosed before HoLEP: 6 patients with GG1 are on active surveillance (AS), 3 of 4 intermediate-risk patients are on AS and 1 received treatment for disease progression, and both high-risk CaP patients achieved symptomatic benefit from HoLEP and are receiving systemic therapy for CaP. Twenty-one patients (11.1%) with incidentally detected CaP at HoLEP remain on AS or watchful waiting based on clinical scenario., Conclusion: Screening for CaP in HoLEP candidates with PSA and MRI is recommended given that >10% will have incidental CaP. After HoLEP for BPH/LUTS, patients with CaP can be surveilled with PSA and/or MRI. Further investigation is warranted to determine the durability of success of these approaches., (Copyright © 2020. Published by Elsevier Inc.)

Purpose: To investigate the performance of pre-surgery CT and multiparametric MRI (mpMRI) to identify lymph node (LN) metastases in the Michigan Urological Surgery Improvement Collaborative (MUSIC). Abdominopelvic CT and mpMRI are commonly used for intermediate- and high-risk prostate cancer (PCa) staging., Methods: Retrospective analysis of the MUSIC registry identified patients undergoing robot-assisted radical prostatectomy (RP) between 3/2012 and 7/2018. Patients were classified according to pre-surgery imaging modality. Primary outcomes were operating characteristics of CT and mpMRI for detection of pathologic LN involvement (pN1)., Results: A total of 10,250 patients underwent RP and 3924 patients (38.3%) underwent CT and/or mpMRI prior to surgery. Suspicion for LN involvement was identified on 2.3% CT and 1.9% mpMRI. Overall, 391 patients were pN1(3.8%), including 0.1% low-, 2.1% intermediate-, and 10.9% high-risk PCa patients. Of 235 pN1 patients that underwent CT prior, far more had negative (91.1%) than positive (8.9%) findings, yielding sensitivity: 8.9%, specificity: 98.3%, negative predictive value (NPV): 92.1%, and positive predictive value (PPV): 32.3% for CT with regard to LN metastases. Similarly, more patients with pN1 disease had negative mpMRI (81.0%) then suspicious or indeterminate MRI (19.0%), yielding sensitivity: 19.0%, specificity: 97.3%, NPV: 95.9%, and PPV: 26.7%., Conclusions: Abdominopelvic CT and mpMRI have clear limitations in identifying LN metastases. Additional clinicopathologic features should be considered when making management decisions, as 2.1% and 10.9% with intermediate-and high-risk cancer had metastatic LNs. The majority of pN1 patients had a negative CT or a negative/indeterminate mpMRI prior to RP. Pelvic LN dissection should be performed in RP patients with intermediate- or high-risk PCa, independent of preoperative imaging results.

Objectives: Prostate cancer (CaP) staging traditionally includes computed tomography (CT) and technetium-99m bone scintigraphy (BS) for assessment of lymph node (LN) and bone metastases, respectively. In recent years, multiparametric magnetic resonance imaging (mpMRI) has been used in diagnostic assessment of CaP. We sought to compare the accuracy of mpMRI to CT and BS for pretreatment staging., Materials and Methods: Using the Michigan Urological Surgery Improvement Collaborative registry, we identified men undergoing pretreatment mpMRI in addition to CT and/or BS in 2012 to 2018. Imaging reports were classified as positive, negative, or equivocal for detection of LN and bone metastases. A best value comparator (BVC) was used to adjudicate metastatic status in the absence of pathologic data. mpMRI accuracy was calculated using pessimistic (equivocal=positive) and optimistic (equivocal = negative) interpretations. We compared the diagnostic performance of mpMRI, CT, and BS in detecting metastases., Results: In total, 364 men underwent CT and mpMRI, and 646 underwent BS and mpMRI. Based on the BVC, 52 men (14%) harbored LN metastases and 38 (5.9%) harbored bone metastases. Sensitivity of mpMRI for LN metastases was significantly higher than CT (65-73% vs 38%, P < 0.005), and specificity of mpMRI and CT were 97% to 99% and 99% (P = 0.2-0.4), respectively. For bone metastases, BS sensitivity was 68% as compared to 42% to 71% (P = 0.02-0.83) for mpMRI. Specificity for bone metastases was 95% to 99% across all modalities., Conclusions: Using statewide data, mpMRI appears superior to CT and comparable to BS for detection of LN and bone metastases, respectively. Pretreatment mpMRI may obviate the need for additional staging imaging., (Copyright © 2020. Published by Elsevier Inc.)

Purpose: Several guidelines recommend pelvic lymph node dissection (PLND) at robot-assisted radical prostatectomy (RARP) only when lymph node involvement (LN+) is >2%. Individual surgeon use of PLND is not well-known. We sought to examine variability in PLND performance and detection of LN+ across the Michigan Urological Surgery Improvement Collaborative., Methods: Data regarding all RARP (3/2012-9/2018) were prospectively collected, including patient and surgeon characteristics. Univariable and multivariable analyses of PLND rate and LN+ rate were performed., Results: Among 9,751 men undergoing RARP, 79.8% had PLND performed (n = 7,781), of which 5.2% were LN+ (n = 404). In univariate and multivariable analyses, predictors of PLND included higher Prostate-Specific Antigen (PSA), biopsy Gleason grade (bGG), number of positive cores, and maximum core involvement at P < 0.05 for each. Higher PSA, cT stage, bGG, number of positive cores, and maximum core involvement predicted LN+ when PLND was performed (P < 0.05 for each). There was significant surgeon variation in the proportion of PLND performed at RARP, yet neither surgeon-annualized RARP volume nor % of PLND performed was associated with LN+ disease (P > 0.05). Grade was associated with PLND (60.0%, 77.6%, 91.0%, 97.3%, and 98.5%; P < 0.001) and LN+ (0.7%, 2.5%, 5.8%, 8.6%, and 19.9%; P < 0.001) for bGG 1,2,3,4,5, respectively. Maximum core involvement also strongly predicted LN+ with rates of 1.5%, 3.8%, and 9.4% for <35%, 35% to 65%, and >65%, respectively (P < 0.001)., Conclusions: Nearly 80% of RARP in Michigan Urological Surgery Improvement Collaborative were performed with PLND, including 60% of bGG1 patients (with LN+ in only 0.7%), but significant variability exists between surgeons. Our data indicate limited benefit for favorable-risk CaP patients and support efforts to decrease PLND use going forward., (Copyright © 2019. Published by Elsevier Inc.)

Background: Closed suction drain (CSD) placement is common in robot-assisted radical prostatectomy (RARP). Our goal is to quantify outcomes of RARP for patients undergoing RARP by surgeons who regularly or selectively use CSDs., Methods: Patients undergoing RARP (4/2014-7/2017) were prospectively entered into the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry. Outcomes included length of stay (LOS) >2 days, >16-day catheterization, 30-day readmission, and clinically significant urine leak or ileus. Retrospective analysis of each adverse event was performed comparing groups using chi-square tests., Results: In all, 6746 RARPs were performed by 115 MUSIC surgeons. CSDs were used in 4451 RARP (66.0%), with wide variation in surgeon CSD use (median: 94.7%, range: 0-100%, IQR: 45-100%). The cohorts of patients treated by surgeons with regular vs. selective CSD usage were similar. CSD use pattern was not associated with rates of prolonged catheterization (4.6% vs. 3.9%, p = 0.17) or readmission (4.5% vs. 4.0%, p = 0.35) and multivariable analysis confirmed these findings (each p > 0.10). Regular CSD use was associated with LOS >2 days (8.4% vs. 6.3%, p = 0.001) and multivariable analyses indicated an odds ratio (OR) of 1.42 (95% CI: 1.12-1.79; p = 0.017) and increased likelihood of clinically significant ileus (OR: 1.64; CI: 1.14-2.35; p = 0.008)., Conclusions: Although there are specific situations in which CSDs are beneficial, e.g. anastomotic leak or observed lymphatic drainage, regular CSD use during RARP was associated with a greater likelihood of LOS >2 days and clinically significant ileus. Our data suggest that CSD should be placed selectively rather than routinely after RARP.

Background: We aimed to validate Decipher to predict adverse pathology (AP) at radical prostatectomy (RP) in men with National Comprehensive Cancer Network (NCCN) favorable-intermediate risk (F-IR) prostate cancer (PCa), and to better select F-IR candidates for active surveillance (AS)., Methods: In all, 647 patients diagnosed with NCCN very low/low risk (VL/LR) or F-IR prostate cancer were identified from a multi-institutional PCa biopsy database; all underwent RP with complete postoperative clinicopathological information and Decipher genomic risk scores. The performance of all risk assessment tools was evaluated using logistic regression model for the endpoint of AP, defined as grade group 3-5, pT3b or higher, or lymph node invasion., Results: The median age was 61 years (interquartile range 56-66) for 220 patients with NCCN F-IR disease, 53% classified as low-risk by Cancer of the Prostate Risk Assessment (CAPRA 0-2) and 47% as intermediate-risk (CAPRA 3-5). Decipher classified 79%, 13% and 8% of men as low-, intermediate- and high-risk with 13%, 10%, and 41% rate of AP, respectively. Decipher was an independent predictor of AP with an odds ratio of 1.34 per 0.1 unit increased (p value = 0.002) and remained significant when adjusting by CAPRA. Notably, F-IR with Decipher low or intermediate score did not associate with significantly higher odds of AP compared to VL/LR., Conclusions: NCCN risk groups, including F-IR, are highly heterogeneous and should be replaced with multivariable risk-stratification. In particular, incorporating Decipher may be useful for safely expanding the use of AS in this patient population.

Abstact: BACKGROUND: Many men diagnosed with prostate cancer are active surveillance (AS) candidates. However, AS may be associated with increased risk of disease progression and metastasis due to delayed therapy. Genomic classifiers, e.g., Decipher, may allow better risk-stratify newly diagnosed prostate cancers for AS., Methods: Decipher was initially assessed in a prospective cohort of prostatectomies to explore the correlation with clinically meaningful biologic characteristics and then assessed in diagnostic biopsies from a retrospective multicenter cohort of 266 men with National Comprehensive Cancer Network (NCCN) very low/low and favorable-intermediate risk prostate cancer. Decipher and Cancer of the Prostate Risk Assessment (CAPRA) were compared as predictors of adverse pathology (AP) for which there is universal agreement that patients with long life-expectancy are not suitable candidates for AS (primary pattern 4 or 5, advanced local stage [pT3b or greater] or lymph node involvement)., Results: Decipher from prostatectomies was significantly associated with adverse pathologic features (p-values < 0.001). Decipher from the 266 diagnostic biopsies (64.7% NCCN-very-low/low and 35.3% favorable-intermediate) was an independent predictor of AP (odds ratio 1.29 per 10% increase, 95% confidence interval [CI] 1.03-1.61, p-value 0.025) when adjusting for CAPRA. CAPRA area under curve (AUC) was 0.57, (95% CI 0.47-0.68). Adding Decipher to CAPRA increased the AUC to 0.65 (95% CI 0.58-0.70). NPV, which determines the degree of confidence in the absence of AP for patients, was 91% (95% CI 87-94%) and 96% (95% CI 90-99%) for Decipher thresholds of 0.45 and 0.2, respectively. Using a threshold of 0.2, Decipher was a significant predictor of AP when adjusting for CAPRA (p-value 0.016)., Conclusion: Decipher can be applied to prostate biopsies from NCCN-very-low/low and favorable-intermediate risk patients to predict absence of adverse pathologic features. These patients are predicted to be good candidates for active surveillance.

Objective: To examine the association between National Comprehensive Cancer Network (NCCN) risk, number of positive biopsy cores, age, and early confirmatory test results on pathological upgrading at radical prostatectomy (RP), in order to better understand whether early confirmatory testing and better risk stratification are necessary for all men with Grade Group (GG) 1 cancers who are considering active surveillance (AS)., Patients and Methods: We identified men in Michigan initially diagnosed with GG1 prostate cancer, from January 2012 to November 2017, who had a RP within 1 year of diagnosis. Our endpoints were: (i) ≥GG2 cancer at RP and (ii) adverse pathology (≥GG3 and/or ≥pT3a). We compared upgrading according to NCCN risk, number of positive biopsy cores, and age. Last, we examined if confirmatory test results were associated with upgrading or adverse pathology at RP., Results: Amongst 1966 patients with GG1 cancer at diagnosis, the rates of upgrading to ≥GG2 and adverse pathology were 40% and 59% (P < 0.001), and 10% and 17% (P = 0.003) for patients with very-low- and low-risk cancers, respectively. Upgrading by volume ranged from 49% to 67% for ≥GG2, and 16% to 23% for adverse pathology. Generally, more patients aged ≥70 vs <70 years had adverse pathology. Unreassuring confirmatory test results had a higher likelihood of adverse pathology than reassuring tests (35% vs 18%, P = 0.017)., Conclusions: Upgrading and adverse pathology are common amongst patients initially diagnosed with GG1 prostate cancer. Early use of confirmatory testing may facilitate the identification of patients with more aggressive disease ensuring improved risk classification and safer selection of patients for AS., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Purpose: The GG (Grade Group) system was introduced in 2013. Data from academic centers suggest that GG better distinguishes between prostate cancer risk groups than the Gleason score (GS) risk groups. We compared the performance of the 2 systems to predict pathological/recurrence outcomes using data from the MUSIC (Michigan Urological Surgery Improvement Collaborative)., Materials and Methods: Patients who underwent biopsy and radical prostatectomy in the MUSIC from March 2012 to June 2017 were classified according to GG and GS. Outcomes included the presence or absence of extraprostatic extension, seminal vesical invasion, positive lymph nodes, positive surgical margins and time to cancer recurrence (defined as postoperative prostate specific antigen 0.2 ng/ml or greater). Logistic and Cox regression models were used to compare the difference in outcomes., Results: A total of 8,052 patients were identified. When controlling for patient characteristics, significantly higher risks of extraprostatic extension, seminal vesical invasion and positive lymph nodes were observed for biopsy GG 3 vs 2 and for GG 5 vs 4 (p <0.001). Biopsy GGs 3, 4 and 5 also showed shorter time to biochemical recurrence than GGs 2, 3 and 4, respectively (p <0.001). GGs 3, 4 and 5 at radical prostatectomy were each associated with a greater probability of recurrence compared to the next lower GG (p <0.001). GG (vs GS) had better predictive power for extraprostatic extension, seminal vesical invasion, positive lymph nodes and biochemical recurrence., Conclusions: GG at biopsy and radical prostatectomy allows for better discrimination of recurrence-free survival between individual risk groups than GS risk groups with GGs 2, 3, 4 and 5 each incrementally associated with increased risk.

Rationale and Objectives: Prostate volume (PV) determination provides important clinical information. We compared PVs determined by digital rectal examination (DRE), transrectal ultrasound (TRUS), magnetic resonance imaging (MRI) with or without three-dimensional (3D) segmentation software, and surgical prostatectomy weight (SPW) and volume (SPV)., Materials and Methods: This retrospective review from 2010 to 2016 included patients who underwent radical prostatectomy ≤1 year after multiparametric prostate MRI. PVs from DRE and TRUS were obtained from urology clinic notes. MRI-based PVs were calculated using bullet and ellipsoid formulas, automated 3D segmentation software (MRI-A3D), manual segmentation by a radiologist (MRI-R3D), and a third-year medical student (MRI-S3D). SPW and SPV were derived from pathology reports. Intraclass correlation coefficients compared the relative accuracy of each volume measurement., Results: Ninety-nine patients were analyzed. Median PVs were DRE 35 mL, TRUS 35 mL, MRI-bullet 49 mL, MRI-ellipsoid 39 mL, MRI-A3D 37 mL, MRI-R3D 36 mL, MRI-S3D 36 mL, SPW 54 mL, SPV-bullet 47 mL, and SPV-ellipsoid 37 mL. SPW and bullet formulas had consistently large PV, and formula-based PV had a wider spread than PV based on segmentation. Compared to MRI-R3D, the intraclass correlation coefficient was 0.91 for MRI-S3D, 0.90 for MRI-ellipsoid, 0.73 for SPV-ellipsoid, 0.72 for MRI-bullet, 0.71 for TRUS, 0.70 for SPW, 0.66 for SPV-bullet, 0.38 for MRI-A3D, and 0.33 for DRE., Conclusions: With MRI-R3D measurement as the reference, the most reliable methods for PV estimation were MRI-S3D and MRI-ellipsoid formula. Automated segmentations must be individually assessed for accuracy, as they are not always truly representative of the prostate anatomy. Manual segmentation of the prostate does not require expert training., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Objective: To better describe the real-world use of active surveillance. Active surveillance is a preferred management option for low-risk prostate cancer, yet its use outside of high-volume institutions is poorly understood. We created multiple claims-based algorithms, validated them using a robust clinical registry, and applied them to Medicare claims to describe national utilization., Materials and Methods: We identified men with prostate cancer from 2012-2014 in a 100% sample of Michigan Medicare data and linked them with the Michigan Urologic Surgery Improvement Collaborative (MUSIC) registry. Using MUSIC treatment assignment as the standard, we determined the performance of 8 claims-based algorithms to identify men on active surveillance. We selected 3 algorithms (the most sensitive, the most specific, and a balanced algorithm incorporating age and comorbidity) and applied them to a 20% national Medicare sample to describe national trends., Results: We identified 1186 men with incident prostate cancer and completely linked data. Eight algorithms were tested with sensitivity ranging from 23.5% to 88.2% and specificity ranging from 93.5% to 99.1%. We found that the use of surveillance for men with incident prostate cancer increased from 2007 to 2014, nationally. However, among all men in the population, there was a large decrease in the rate of prostate cancer diagnosis and an increased or stable rate in the use of active surveillance, depending on the algorithm used. Less than 25% of men on active surveillance underwent a confirmatory prostate biopsy., Conclusion: We describe the performance of claims-based algorithms to identify active surveillance., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: To examine the relationship between the use and results of early confirmatory testing and persistence on active surveillance (AS)., Methods: We identified all men in the Michigan Urological Surgery Improvement Collaborative registry diagnosed with favorable-risk prostate cancer from June 2016 to June 2017. We next examined trends in the use of early confirmatory test(s), defined as repeat biopsy, prostate magnetic resonance imaging, or molecular classifiers obtained within 6 months of the initial cancer diagnosis, in patients with favorable-risk prostate cancer. We then compared the proportion of men remaining on AS 6 months after diagnosis according to reassuring vs nonreassuring results, also stratifying by age and Gleason score., Results: Among 2529 patients, 32.7% underwent early confirmatory testing within 6 months of diagnosis. Its use increased from 25.4% in the second quarter of 2016 to 34.9% in the second quarter of 2017 (P = .025). Molecular classifiers were most frequently used (55%), followed by magnetic resonance imaging (34%) and repeat biopsy (11%). Sixty-four percent (n = 523) had a reassuring result. Rates of AS were higher for patients with early reassuring results; 82% remained on AS (n = 427) compared to 52% (n = 157) of those with nonreassuring results and 51% (n = 873) with no early confirmatory testing (P <.001)., Conclusion: Rates of AS are higher among men with early reassuring results, supporting the clinical utility of these tests. Nonetheless, high rates of AS among patients with nonreassuring results underscore the complexity of shared decision-making in this setting., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: To evaluate the integration of 3T nonendorectal coil multiparametric prostate magnetic resonance imaging (mpMRI) at 2 high-volume practices that routinely use mpMRI in the setting of active surveillance., Materials and Methods: This was an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant, and dual-institution retrospective cohort study. Subjects undergoing 3T mpMRI without endorectal coil at either study institution over a 13-month period (August 1, 2015-August 31, 2016) were selected based on predefined criteria: clinical T1/T2 Gleason 6 prostate cancer, prostate-specific antigen <15 ng/mL, ≥40 years old, mpMRI within 2 years of prostate biopsy, and Prostate Imaging Reporting and Data System (PI-RADS) v2 score assigned. Subjects surveilled for Gleason ≥3 + 4 prostate cancer were excluded. The primary outcome was detection of Gleason ≥3 + 4 prostate cancer on magnetic resonance-ultrasound fusion biopsy, standard biopsy, or prostatectomy within 6 months following mpMRI. Positive predictive values (PPVs) were calculated., Results: A total of 286 subjects (N = 193 from institution 1, N = 93 from institution 2) met the criteria. Most (87% [90 of 104]) with maximum PI-RADS v2 scores of 1-2 did not receive immediate biopsy or treatment and remained on active surveillance. Incidence and PPVs for PI-RADS v2 scores of ≥3 were the following: PI-RADS 3 (n = 57 [20%], PPV 21% [6 of 29]), PI-RADS 4 (n = 96 [34%], PPV 51% [39 of 77]), and PI-RADS 5 (n = 29 [13%], PPV 71% [20 of 28]). No Gleason ≥4 + 3 prostate cancer was identified for PI-RADS v2 scores of 1-3 (0 of 43 with histology). Following mpMRI and subsequent biopsy, 21% (61 of 286) of subjects were removed from active surveillance and underwent definitive therapy., Conclusion: The 3T nonendorectal coil mpMRI has been integrated into the care of patients on active surveillance and effectively stratifies risk of Gleason ≥3 + 4 prostate cancer in this population., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Active surveillance (AS) is an increasingly prevalent treatment choice for low grade prostate cancer. Eligibility criteria for AS are varied and it is unclear if family history of prostate cancer should be used as an exclusion criterion when considering men for AS. To determine whether family history plays a significant role in the progression of prostate cancer for men undergoing active surveillance, PubMed searches of 'family history and prostate cancer', 'family history and prostate cancer progression' and 'factors of prostate cancer progression' were used to identify research publications about the relationship between family history and prostate cancer progression. These searches generated 536 papers that were screened and reviewed. Six publications were ultimately included in this analysis. Review of the six publications suggests that family history does not increase the risk of prostate cancer progression, whilst a subgroup analysis in one study found that family history increases the risk of prostate cancer progression only in African-Americans. A family history of prostate cancer does not appear to increase a patient's risk of having more aggressive prostate cancer and is therefore unlikely to be an important factor in determining eligibility for AS. Further studies are needed to better understand the relationship between race, family history, and eligibility for AS., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Background: Patients with prostate cancer and their providers face uncertainty as they consider adjuvant radiotherapy (ART) or salvage radiotherapy (SRT) after undergoing radical prostatectomy. The authors prospectively evaluated the impact of the Decipher test, which predicts metastasis risk after radical prostatectomy, on decision making for ART and SRT., Methods: A total of 150 patients who were considering ART and 115 who were considering SRT were enrolled. Providers submitted a management recommendation before processing the Decipher test and again at the time of receipt of the test results. Patients completed validated surveys on prostate cancer (PCa)-specific decisional effectiveness and PCa-related anxiety., Results: Before the Decipher test, observation was recommended for 89% of patients considering ART and 58% of patients considering SRT. After Decipher testing, 18% (95% confidence interval [95% CI], 12%-25%) of treatment recommendations changed in the ART arm, including 31% among high-risk patients; and 32% (95% CI, 24%-42%) of management recommendations changed in the salvage arm, including 56% among high-risk patients. Decisional Conflict Scale (DCS) scores were better after viewing Decipher test results (ART arm: median DCS before Decipher, 25 and after Decipher, 19 [P<.001]; SRT arm: median DCS before Decipher, 27 and after Decipher, 23 [P<.001]). PCa-specific anxiety changed after Decipher testing; fear of PCa disease recurrence in the ART arm (P = .02) and PCa-specific anxiety in the SRT arm (P = .05) decreased significantly among low-risk patients. Decipher results reported per 5% increase in 5-year metastasis probability were associated with the decision to pursue ART (odds ratio, 1.48; 95% CI, 1.19-1.85) and SRT (odds ratio, 1.41; 95% CI, 1.09-1.81) in multivariable logistic regression analysis., Conclusions: Knowledge of Decipher test results was associated with treatment decision making and improved decisional effectiveness among men with PCa who were considering ART and SRT. Cancer 2017;123:2850-59. © 2017 American Cancer Society., (© 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.)

Purpose: The adoption of active surveillance varies widely across urological communities, which suggests a need for more consistency in the counseling of patients. To address this need we used the RAND/UCLA Appropriateness Method to develop appropriateness criteria and counseling statements for active surveillance., Materials and Methods: Panelists were recruited from MUSIC urology practices. Combinations of parameters thought to influence decision making were used to create and score 160 theoretical clinical scenarios for appropriateness of active surveillance. Recent rates of active surveillance among real patients across the state were assessed using the MUSIC registry., Results: Low volume Gleason 6 was deemed highly appropriate for active surveillance whereas high volume Gleason 6 and low volume Gleason 3+4 were deemed appropriate to uncertain. No scenario was deemed inappropriate or highly inappropriate. Prostate specific antigen density, race and life expectancy impacted scores for intermediate and high volume Gleason 6 and low volume Gleason 3+4. The greatest degree of score dispersion (disagreement) occurred in scenarios with long life expectancy, high volume Gleason 6 and low volume Gleason 3+4. Recent rates of active surveillance use among real patients ranged from 0% to 100% at the provider level for low or intermediate biopsy volume Gleason 6, demonstrating a clear opportunity for quality improvement., Conclusions: By virtue of this work urologists have the opportunity to present specific recommendations from the panel to their individual patients. Community-wide efforts aimed at increasing rates of active surveillance and reducing practice and physician level variation in the choice of active surveillance vs treatment are warranted., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: A priority of MUSIC (Michigan Urological Surgery Improvement Collaborative) is to improve patient outcomes after radical prostatectomy. As part of these efforts we developed a novel system that uses unambiguous events to define an uncomplicated 30-day postoperative recovery and compares these outcomes across diverse urology practices., Materials and Methods: MUSIC used a consensus approach to develop an uncomplicated recovery pathway comprising a set of precise perioperative events that are reliably measured and collectively reflect resource utilization, technical complications and coordination of care. Events that occurred outside the uncomplicated recovery pathway were considered deviations, including rectal injury, high blood loss, extended length of stay, prolonged drain or catheter placement, catheter replacement, hospital readmission or mortality. For men undergoing radical prostatectomy trained abstractors prospectively recorded clinical and perioperative data in an electronic registry. When a deviation from the NOTES (Notable Outcomes and Trackable Events after Surgery) pathway occurred, precipitating events were described by abstractors and we analyzed the events., Results: From April 2014 through July 2015 a total of 2,245 radical prostatectomies were performed by 100 surgeons in a total of 37 diverse participating MUSIC practices. In the 29 practices in which 10 or more radical prostatectomies were performed during the interval analyzed the risk adjusted deviation rate ranged from 0.0% to 46.1% (p <0.0001). Anastomotic and gastrointestinal events were contributing factors in 50.2% of deviated cases., Conclusions: The novel NOTES system provides comparative data on unambiguous and actionable short-term outcomes after radical prostatectomy. The observed variation in outcomes across practices suggests opportunities for quality improvement initiatives. Decreasing anastomotic and gastrointestinal events represents a high impact opportunity for initial quality improvement efforts., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Active surveillance (AS) has been proposed as an effective strategy to reduce overtreatment among men with lower risk prostate cancers. However, historical rates of initial surveillance are low (4-20%), and little is known about its application among community-based urology practices., Objective: To describe contemporary utilization of AS among a population-based sample of men with low-risk prostate cancer., Design, Setting, and Participants: We performed a prospective cohort study of men with low-risk prostate cancer managed by urologists participating in the Michigan Urological Surgery Improvement Collaborative (MUSIC)., Outcome Measurements and Statistical Analysis: The principal outcome was receipt of AS as initial management for low-risk prostate cancer including the frequency of follow-up prostate-specific antigen (PSA) testing, prostate biopsy, and local therapy. We examined variation in the use of surveillance according to patient characteristics and across MUSIC practices. Finally, we used claims data to validate treatment classification in the MUSIC registry., Results and Limitations: We identified 682 low-risk patients from 17 MUSIC practices. Overall, 49% of men underwent initial AS. Use of initial surveillance varied widely across practices (27-80%; p=0.005), even after accounting for differences in patient characteristics. Among men undergoing initial surveillance with at least 12 mo of follow-up, PSA testing was common (85%), whereas repeat biopsy was performed in only one-third of patients. There was excellent agreement between treatment assignments in the MUSIC registry and claims data (κ=0.93). Limitations include unknown treatment for 8% of men with low-risk cancer., Conclusions: Half of men in Michigan with low-risk prostate cancer receive initial AS. Because this proportion is much higher than reported previously, our findings suggest growing acceptance of this strategy for reducing overtreatment., Patient Summary: We examined the use of initial active surveillance for the management of men with low-risk prostate cancer across the state of Michigan. We found that initial surveillance is used much more commonly than previously reported, but the likelihood of a patient being placed on surveillance depends strongly on where he is treated., (Published by Elsevier B.V.)

Purpose: There remains significant controversy surrounding the optimal criteria for recommending prostate biopsy. To examine this issue further urologists in MUSIC assessed statewide prostate biopsy practice patterns and variation in prostate cancer detection., Materials and Methods: MUSIC is a statewide, physician led collaborative designed to improve prostate cancer care. From March 2012 through June 2013 at 17 MUSIC practices standardized clinical and pathological data were collected on a total of 3,015 men undergoing first-time prostate biopsy. We examined pathological biopsy outcomes according to patient characteristics and across MUSIC practices., Results: The average cancer detection rate was 52% with significant variability across MUSIC practices (range 43% to 70%, p<0.0001). Of all patients biopsied 27% were older than 69 years, ranging from 19% to 36% at individual practices. Men with prostate specific antigen less than 4 ng/ml comprised an average of 26% of the study population (range 10% to 37%). The detection rate in patients older than 69 years ranged from 42% to 86% at individual practices (p=0.0008). In the 793 patients with prostate specific antigen less than 4 ng/ml the cancer detection rate ranged from 22% to 58% across individual practices (p=0.0065). The predicted probability of cancer detection varied significantly across MUSIC practices even after adjusting for patient age, prostate specific antigen, prostate size, family history and digital rectal examination findings (p<0.0001)., Conclusions: While overall detection rates are higher than previously reported, the cancer yield of prostate biopsy varies widely across urology practices in Michigan. These data serve as a foundation for our efforts to understand and improve patient selection for prostate biopsy., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: While transrectal prostate biopsy is the cornerstone of prostate cancer diagnosis, serious post-biopsy infectious complications are reported to be increasing. A better understanding of the true prevalence and microbiology of these events is needed to guide quality improvement in this area and ultimately better early detection practices., Materials and Methods: Using data from the MUSIC registry we identified all men who underwent transrectal prostate biopsy at 21 practices in Michigan from March 2012 to June 2013. Trained data abstractors recorded pertinent data including prophylactic antibiotics and all biopsy related hospitalizations. Claims data and followup telephone calls were used for validation. All men admitted to the hospital for an infectious complication were identified and their culture data were obtained. We then compared the frequency of infection related hospitalization rates across practices and according to antibiotic prophylaxis in concordance with AUA best practice recommendations., Results: The overall 30-day hospital admission rate after prostate biopsy was 0.97%, ranging from 0% to 4.2% across 21 MUSIC practices. Of these hospital admissions 95% were for infectious complications and the majority of cultures identified fluoroquinolone resistant organisms. AUA concordant antibiotics were administered in 96.3% of biopsies. Patients on noncompliant antibiotic regimens were significantly more likely to be hospitalized for infectious complications (3.8% vs 0.89%, p=0.0026)., Conclusions: Infection related hospitalizations occur in approximately 1% of men undergoing prostate biopsy in Michigan. Our findings suggest that many of these events could be avoided by implementing new protocols (eg culture specific or augmented antibiotic prophylaxis) that adhere to AUA best practice recommendations and address fluoroquinolone resistance., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Several germline single nucleotide polymorphisms (SNPs) have been consistently associated with prostate cancer (PCa) risk., Objective: To determine whether there is an improvement in PCa risk prediction by adding these SNPs to existing predictors of PCa., Design, Setting, and Participants: Subjects included men in the placebo arm of the randomized Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial in whom germline DNA was available. All men had an initial negative prostate biopsy and underwent study-mandated biopsies at 2 yr and 4 yr. Predictive performance of baseline clinical parameters and/or a genetic score based on 33 established PCa risk-associated SNPs was evaluated., Outcome Measurements and Statistical Analysis: Area under the receiver operating characteristic curves (AUC) were used to compare different models with different predictors. Net reclassification improvement (NRI) and decision curve analysis (DCA) were used to assess changes in risk prediction by adding genetic markers., Results and Limitations: Among 1654 men, genetic score was a significant predictor of positive biopsy, even after adjusting for known clinical variables and family history (p = 3.41 × 10(-8)). The AUC for the genetic score exceeded that of any other PCa predictor at 0.59. Adding the genetic score to the best clinical model improved the AUC from 0.62 to 0.66 (p<0.001), reclassified PCa risk in 33% of men (NRI: 0.10; p=0.002), resulted in higher net benefit from DCA, and decreased the number of biopsies needed to detect the same number of PCa instances. The benefit of adding the genetic score was greatest among men at intermediate risk (25th percentile to 75th percentile). Similar results were found for high-grade (Gleason score ≥ 7) PCa. A major limitation of this study was its focus on white patients only., Conclusions: Adding genetic markers to current clinical parameters may improve PCa risk prediction. The improvement is modest but may be helpful for better determining the need for repeat prostate biopsy. The clinical impact of these results requires further study., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: We compared prostate cancer detection rates for the 2 most commonly used transrectal ultrasound prostate biopsy probes, end fire and side fire, to determine whether the probe configuration affects detection rates., Materials and Methods: We evaluated 2,674 patients who underwent initial prostate biopsy between 2000 and 2008 with respect to prostate specific antigen, biopsy technique and pathological findings. Patients were divided into 1,124 in whom biopsies were performed with an end fire probe and 1,550 in whom biopsies were performed with a side fire probe., Results: There was a significant difference in the overall cancer detection rate in the end vs side fire arms (45.8% vs 38.5%, p <0.001). In the subsets of patients with prostate specific antigen greater than 4 to 10 ng/ml or less and greater than 10 ng/ml a significant difference persisted (46.4% vs 38.9% and 61.7% vs 49.1%, p <0.004 and <0.015, respectively). There was also a significant difference in detection rates between probes in those who underwent 8 to 19 biopsy cores (p <0.009). Biopsies of greater than 20 cores failed to attain statistical significance (p >0.105). We also found that prostate volume, patient age, prostate specific antigen and hypoechoic findings were independent variables for predicting cancer detection on multivariate analysis (p <0.001)., Conclusions: The type of probe significantly affects the overall prostate cancer detection rate, particularly in patients with prostate specific antigen greater than 4 ng/ml and/or nonsaturation (8 to 19 cores) prostate biopsy. This may be because the end fire probe allows better mechanical sampling of the lateral and apical regions of the peripheral zone, where cancer is most likely to reside. We set the stage for a randomized, controlled trial to confirm our observations.

Objectives: To evaluate, in a prospective study, the association between low testosterone and pathologic endpoints and the risk of biochemical progression. Androgens play a key role in prostate cancer progression. The results from 3 retrospective studies have suggested that low pretreatment testosterone is an independent predictor of adverse pathologic features in patients with localized prostate cancer., Methods: Routine preoperative total testosterone values were measured in 455 consecutive patients with clinically localized prostate cancer who underwent radical prostatectomy. The association of low testosterone levels (defined a priori as <220 ng/dL) with the pathologic endpoints and the risk of biochemical recurrence using a validated postoperative nomogram was evaluated in univariate and multivariate analyses., Results: No association between low testosterone and the predicted risk of biochemical recurrence (P = .159) or actual disease progression (P = .9) was observed. On multivariate analysis, low testosterone was associated with a predominance of Gleason pattern 4-5 cancer (odds ratio 2.4, 95% confidence interval 1.01-5.7; P = .048). No association of low testosterone with tumor volume was observed (P = .9)., Conclusions: In this prospective study, low pretreatment total testosterone was associated with Gleason pattern 4-5 cancer at prostatectomy, but not with disease progression thereafter. The clinical utility of the serum testosterone level for patients with localized prostate cancer is therefore marginal. These data are consistent with the hypothesis that tumors arising in a low-androgen environment might appear to be of higher grade but are not at increased risk of progression.

Purpose: We investigated whether prostate cancer diagnosed on initial prostate biopsy had worse pathological outcomes compared to that diagnosed on repeat prostate biopsy., Materials and Methods: We reviewed 905 newly diagnosed prostate cancer cases from 2000 to 2007. Patients were stratified by the number of previous biopsies, including the initial biopsy in 690, and 1 and 2 or greater negative previous biopsies in 142 and 73, respectively. We analyzed Gleason sum, number of cores taken, percent of positive cores and bilaterality of prostate cancer. Clinically insignificant cancers were defined according to prostate specific antigen density 0.4 ng/ml or less, 3 or fewer positive cores, 50% or less of maximum cancer in any core and Gleason sum 6 or less., Results: Prostate cancer was diagnosed in 57%, 23% and 21% of cases in the initial, and 1 and 2 or greater negative previous biopsies groups, respectively. Initial prostate biopsy showed a higher number and percent of positive cores, and the maximum percent of prostate cancer involved in a core. However, the Gleason pattern distribution differed significantly in the 3 groups with the highest percent (14%) of Gleason sum 8 or greater in the subset with 2 or greater negative previous biopsies (p <0.01). On multivariate analysis accounting for prostate specific antigen, digital rectal examination, age and biopsy schema the number of previous biopsies was an independent predictor of the number and percent of positive cores, maximum prostate cancer involved in a core, and bilaterality (p <0.01). Only prostate specific antigen, digital rectal examination and age but not the number of previous biopsies independently predicted Gleason sum (p <0.01)., Conclusions: Prostate cancer diagnosed on initial prostate biopsy had higher volume. However, there were a significant number of high grade prostate cancers detected on the third or greater prostate biopsy, underscoring the importance of repeat prostate biopsy in the setting of increased or increasing prostate specific antigen despite negative previous prostate biopsy.

Purpose: It has been reported that the prostate cancer detection rate in men with prostate specific antigen 2.5 ng/ml or greater undergoing saturation (20 cores or greater) prostate biopsy as an initial strategy is not higher than that in men who undergo 10 to 12 core prostate biopsy. At a median followup of 3.2 years we report the cancer detection rate on subsequent prostate biopsy in men who underwent initial saturation prostate biopsy., Materials and Methods: Saturation prostate biopsy was used as an initial biopsy strategy in 257 men between January 2002 and April 2006. Cancer was initially detected in 43% of the patients who underwent saturation prostate biopsy. In the 147 men with negative initial saturation prostate biopsy followup including digital rectal examination and repeat prostate specific antigen measurement was recommended at least annually. Persistently increased prostate specific antigen or an increase in prostate specific antigen was seen as an indication for repeat saturation prostate biopsy., Results: During the median followup of 3.2 years after negative initial saturation prostate biopsy 121 men (82%) underwent subsequent evaluation with prostate specific antigen and digital rectal examination. Median prostate specific antigen remained 4.0 ng/ml or greater in 57% of the men and it increased by 1 ng/ml or greater in 23%. Cancer was detected in 14 of 59 men (24%) undergoing repeat prostate biopsy for persistent clinical suspicion of prostate cancer. No significant association was demonstrated between cancer detection and initial or followup prostate specific antigen, or findings of atypia and high grade prostatic intraepithelial neoplasia on initial saturation prostate biopsy. Cancers detected on repeat prostate biopsy were more likely to be Gleason 6 and organ confined at prostatectomy than were those diagnosed on initial saturation prostate biopsy., Conclusions: Previous experience suggests that, while office based saturation prostate biopsy improves cancer detection in men who have previously undergone a negative prostate biopsy, it does not improve cancer detection as an initial biopsy technique. We now report that the false-negative rate on subsequent prostate biopsy after initial saturation prostate biopsy is equivalent to that following traditional prostate biopsy. These data provide further evidence against saturation prostate biopsy as an initial strategy.

Objectives: One option for the management of low-grade, low-stage prostate cancer is to delay or forego treatment unless evidence of an increased risk of disease progression exists. Accurate assessment of the disease extent and aggressiveness is necessary to determine the candidates for active surveillance (AS). Office-based saturation prostate biopsy (SB) provides more accurate staging than traditional biopsy; therefore, we studied its role in patients on an AS protocol., Methods: Our database identified 52 men with prostate cancer treated with AS from July 2000 to May 2007. The records were reviewed to determine the role of SB in determining the need for definitive therapy., Results: The patients had a median age of 69 years (range 51 to 83) and median prostate-specific antigen (PSA) level of 5.1 ng/mL (range 0.5 to 47). Patients underwent subsequent staging 20-core SB a median of 9 months (range 1 to 20 months) after diagnosis. The disease of 20 patients (38%) was upstaged as defined by an increase in Gleason score or increased disease volume, leading to a recommendation for active treatment. Patients with disease upstaging had had significantly fewer cores taken at the initial diagnostic biopsy (11% with 20 cores or more compared with 55% with fewer than 20 cores, P = 0.002)., Conclusions: SB might lead to a more accurate assessment of the extent and grade of disease in men with prostate cancer on an AS protocol than traditional biopsy. In our series, more than one half of patients who pursue an AS protocol delayed or avoided local therapy. No patient developed clinical metastasis, but long-term surveillance is required.

Objectives: No consensus exists regarding the prognostic value of tumor volume (TV) in predicting biochemical recurrence (BCR) of prostate cancer, especially late in the prostate-specific antigen (PSA) era. We assessed this relationship in a large cohort of patients treated at one institution with standardized pathologic assessment from 1998 to 2005., Methods: Data were collected for 1833 patients undergoing radical prostatectomy for clinically localized prostate cancer since 1998. Patients receiving neoadjuvant or adjuvant therapy or with node-positive disease were excluded. Along with the routine pathologic assessment, TV was prospectively assessed in all specimens. BCR was defined as two consecutive PSA levels of 0.2 ng/mL or one PSA level of greater than 0.2 ng/mL., Results: Although a larger TV correlated with lower rates of biochemical relapse-free survival in patients with a surgical Gleason score of 7 (P <0.0001) and surgical Gleason score of 8 or greater (P = 0.0459), the biochemical relapse-free survival rate at 4 years for low, medium, and extensive surgical Gleason score 6 or less tumors was 95%, 96%, and 97%, respectively (P = 0.65). In a multivariate model, including TV, initial PSA, EPE, seminal vesicle invasion, and surgical Gleason score, the TV predicted for BCR (P = 0.0176)., Conclusions: The results of this large study suggest that a large TV is an independent predictor of BCR in patients with tumors of specimen Gleason score 7 or higher. In contrast, most grade 6 tumors will be organ confined, even if of high volume, and TV will not predict for BCR in these patients.

Objectives: Urinary incontinence and erectile dysfunction remain the long-term complications that affect most patients' lives after radical prostatectomy. Previous reports evaluating incontinence have focused on volumes of urine loss and daily pad use to assess these issues. We have observed that small volumes of urinary incontinence during sexual activity can be just as disconcerting to patients. We attempt to further describe and assess the phenomenon of urinary incontinence with ejaculation in a series of patients., Methods: We reviewed the experience of one physician who received referrals for the treatment of erectile dysfunction after radical prostatectomy from July 2002 to March 2005 and identified 26 men experiencing urine leak predominantly during ejaculation. Questionnaires assessing urinary incontinence were sent to all these patients., Results: The mean age was 62 years (range 54 to 73). Sixteen patients underwent bilateral nerve-sparing, five unilateral nerve-sparing, and five nonnerve-sparing radical retropubic prostatectomy. At a median follow-up of 42 months (range 15 to 118), all patients had experienced urine leakage (volume 0.5 teaspoon to 1 cup) during ejaculation. The incontinence questionnaire revealed that most patients had mild incontinence; however, they experienced ejaculatory urine incontinence "most, or all of the time" and considered it a "big problem.", Conclusions: Although the prevalence of ejaculatory urine incontinence is unclear, in our experience it occurs often enough to be considered a part of the routine postprostatectomy evaluation. A better understanding of the pathophysiology of postprostatectomy incontinence will lead to targeted therapy and an improved quality of life for the patient.

Objectives: To report a series of patients with mucinous (colloid) adenocarcinoma (MC) at prostatectomy who were treated at a single institution from 1987 to 2005. MC is a rare form of prostate cancer reported in some cases to have a more aggressive clinical course than conventional adenocarcinoma (AC)., Methods: Radical prostatectomy specimens with mucinous features were identified from a database of 3613 consecutive patients. Each case was reviewed again by a single pathologist who confirmed the diagnosis of MC in 14 patients. MC was defined by the presence of pools of extracellular mucin in more than 25% of the tumor. Eighteen additional cases were identified in which the mucinous component occupied only a small portion of the tumor and were referred to as AC with focal mucin (AFM). The biochemical and overall survival of 26 patients with MC or AFM who had completed > or = 6 months of follow-up was analyzed using Kaplan-Meier estimates., Results: No patients with MC or AFM died of disease, and 11 (91.7%) of 12 patients with MC and 9 (64.3%) of 14 patients with AFM were clinically and biochemically free of disease. No significant difference was found in biochemical recurrence or overall survival between those with MC or AFM and a matched group of patients with AC., Conclusions: We report what we believe to be the largest published series of cases of MC (n = 14) with a median overall follow-up of 6.4 years. MC appears to behave clinically in a similar fashion to AC, with no statistically significant difference in biochemical failure or survival.

Purpose: An increasing number of men are being treated with BT or a combination of external beam radiation therapy and BT for localized prostate cancer. Although uncommon, the most severe complication following these procedures is RUF. We reviewed our recent experience with RUF following radiotherapy for prostate cancer to clarify treatment in these patients., Materials and Methods: We recently treated 22 men with RUF following primary radiotherapy for adenocarcinoma of the prostate in 21 and adjuvant external beam radiation therapy following radical prostatectomy in 1. Time from the last radiation treatment to fistula presentation was 6 months to 20 years., Results: Four patients underwent proctectomy with permanent fecal and urinary diversion. RUF repair in 5 patients was performed with preservation of fecal or urinary function. Six patients were candidates for reconstruction with preservation of urinary and rectal function, including 5 who underwent proctectomy, staged colo-anal pull-through and BMG repair of the urethral defect. The additional patient underwent primary closure of the rectum, BMG repair of the urethra and gracilis muscle interposition. Successful fistula closure was achieved in the 9 patients who underwent urethral reconstruction. All 8 candidates for rectal reconstruction showed radiological and clinical bowel integrity postoperatively with 2 awaiting final diverting stoma closure., Conclusions: With the increasing use of prostate BT the number of patients with severe rectal injury will likely continue to increase. Radiotherapy induced RUF carries significant morbidity and most patients are treated initially with fecal and urinary diversion. In properly selected patients good outcomes can be expected following repair using BMG for the urethral defect along with colo-anal pull-through or primary rectal repair and gracilis muscle interposition.