The added influence of genomics and post-MRI confirmatory biopsy results to MRI results alone on medical decision making for men with favorable risk prostate cancer being considered for active surveillance.

BACKGROUND: We examined how the results of genomic classifier (GC) or post-magnetic resonance imaging confirmatory biopsy (pMRI-CBx) influenced management strategy for men with an MRI considering active surveillance (AS). METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative registry for men with favorable-risk prostate cancer. Among men with an MRI after the diagnostic biopsy (n = 1162) a subset also had GC (n = 126) or pMRI-CBx (n = 309). Results of MRI, GC, and pMRI-CBx were deemed reassuring (RA) or non-reassuring (Non-RA). We assess the association of the combination of test results obtained with the selection of AS. Proportions were compared with the Fisher's exact test. Multivariable logistic regression models were fit for an association of test results with the selection of AS. RESULTS: The results of pMRI-CBx tended to influence management decisions greater than that of GC, especially in situation where testing results were discordant with the MRI result. Fewer men with a RA MRI and non-RA pMRI-CBx where managed with AS compared with RA MRI alone (31% vs. 86%, p < 0.001). non-RA genomics did not seem to have the same influence on management as non-RA pMRI-CBx as a similar proportion of men with RA MRI and non-RA genomics were managed with AS compared with RA MRI alone (85% vs. 86%, p = 0.753). More men with non-RA MRI and RA pMRI-CBx were managed with AS compared with non-RA MRI alone (89% vs. 40%, p < 0.001). Alternatively, a similar proportion of men with non-RA MRI and RA genomics were managed with AS compared with non-RA MRI alone (42% vs. 40%, p > 0.999). In the multivariable models, pMRI-CBx results influenced the decision for AS versus treatment. CONCLUSIONS: In men with newly diagnosed prostate cancer and an MRI, the additional information provided by pMRI-CBx influenced the decision of AS versus treatment, while the addition of GC results were less influential.

Delayed radical prostatectomy after a period of active surveillance is not associated with the use of secondary treatments compared with immediate prostatectomy.

BACKGROUND: We evaluated the use of secondary treatments in men with grade group (GG) 1 PC following a period of active surveillance (AS) compared with men undergoing immediate radical prostatectomy (RP) to evaluate what is potentially lost in terms of cancer control, if a patient trials AS and transitions to treatment. METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry for men with GG1 PC undergoing RP from April 2012 to July 2018. Men were classified into groups based on time from diagnosis to RP: immediate (surgery within 1 year of diagnosis) and delayed RP (surgery >1 year after initiation of AS). Time to secondary treatment was estimated using Kaplan-Meier curves and compared using the log-rank test. A multivariable Cox proportional hazards model was fit to assess the association between timing of RP and use of secondary treatments. A chi-squared test was used to assess the association between delayed RP and adverse pathology. RESULTS: We identified 1878 men that underwent an RP during the study period, of which 1489 (79%) underwent immediate RP and 389 (21%) underwent delayed RP. The incidence of adverse pathology was higher in men with delayed versus immediate RP (49% vs. 36%, p < 0.0001, respectively). However, we noted only a small absolute difference in the estimated 24-month secondary treatment-free probability between men with delayed versus immediate RP (93% and 96%, respectively). On multivariable analysis, delayed RP was associated with increased use of secondary treatments (hazard ratio = 1.94, 95% confidence interval = 1.23-3.06, p = 0.004). CONCLUSIONS: The use of secondary treatment after RP in men with GG1 PC undergoing immediate or delayed prostatectomy was rare. These data suggest that the burden of treatment is near equivalent in patients who progress to treatment on AS compared with those who underwent immediate RP.

Impact of Early Confirmatory Tests on Upgrading and Conversion to Treatment in Prostate Cancer Patients on Active Surveillance.

OBJECTIVES: To assess the impact of confirmatory tests on active surveillance (AS) biopsy disease reclassification and progression to treatment in men with favorable risk prostate cancer (FRPC). METHODS: We searched the MUSIC registry for men with FRPC managed with AS without or with a confirmatory test. Confirmatory tests included (1) repeat prostate biopsy, (2) genomic tests, (3) prostate magnetic resonance imaging (MRI), or (4) MRI followed by a post-MRI biopsy. Confirmatory test results were deemed reassuring (RA) or nonreassuring (nonRA) according to predefined criteria. Kaplan-Meier curves and multivariable Cox regression models were used to compare surveillance biopsy disease reclassification-free survival and treatment-free survival. RESULTS: Of the 2,514 men with FRPC who were managed on AS, 1211 (48%) men obtained a confirmatory test. We noted differences in the 12-month unadjusted surveillance biopsy disease reclassification-free probability (68%, 83%, and 90%, P < .0001) and 24-month unadjusted treatment-free probability (55%, 81%, and 79%, P < .0001), for men with nonRA confirmatory tests, no confirmatory test, and RA confirmatory tests, respectively. Excluding patients with genomic confirmatory tests, men with RA confirmatory tests were associated with a lower hazard (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.38-0.84, P = .005) and men with nonRA confirmatory tests had an increased hazard (HR 1.97, 95% CI 1.22-3.19, P = .006) of surveillance disease reclassification compared with men without confirmatory tests in the multivariable model. CONCLUSION: These data suggest men with RA confirmatory tests have less surveillance biopsy reclassification and remain on AS longer than men with nonRA test results. Confirmatory tests may help risk stratify men considering active surveillance.

Overtreatment and Underutilization of Watchful Waiting in Men With Limited Life Expectancy: An Analysis of the Michigan Urological Surgery Improvement Collaborative Registry.

OBJECTIVE: To determine rates of watchful waiting (WW) vs treatment in prostate cancer (PCa) and limited life expectancy (LE) and assess determinants of management. MATERIALS AND METHODS: Patients diagnosed with PCa between 2012 and 2018 with <10 years LE were identified from the Michigan Urologic Surgery Improvement Collaborative registry. Multinomial logistic regression models were used to identify factors associated with management choice among NCCN low-risk PCa patients. Data from high-volume practices were analyzed to understand practice variation. RESULTS: Total 2393 patients were included. Overall, WW was performed in 8.1% compared to 23.3%, 25%, 11.2%, and 3.6% who underwent AS, radiation (XRT), prostatectomy (RP), and brachytherapy (BT), respectively. In men with NCCN low-risk disease (n = 358), WW was performed in 15.1%, compared to AS (69.3%), XRT (4.2%), RP (6.7%), and BT (2.5%). There was wide variation in management among practices in low-risk men; WW (6%-35%), AS (44%-81%), and definitive treatment (0%-30%). Older age was associated with less likelihood of undergoing AS vs WW (odds ratio [OR] 0.88, P < .001) or treatment vs WW (OR 0.83, P < .0001). Presence of ≥cT2 disease (OR 8.55, P = .014) and greater number of positive biopsy cores (OR 1.41, P = .014) was associated with greater likelihood of treatment vs WW and Charlson comorbidity score of 1 vs 0 (OR 0.23, P = .043) was associated with less likelihood of treatment vs WW. CONCLUSION: Wide practice level variation exists in management for patients with low- and favorable-risk PCa and <10-year LE. Utilization of WW is poor, suggesting overtreatment in men who will experience little benefit.

Confirmatory Magnetic Resonance Imaging with or without Biopsy Impacts Decision Making in Newly Diagnosed Favorable Risk Prostate Cancer.

PURPOSE: We investigated how magnetic resonance imaging and post-magnetic resonance imaging biopsy impact decision making in men considering active surveillance. MATERIALS AND METHODS: We reviewed the records of men in the Michigan Urological Surgery Improvement Collaborative with newly diagnosed favorable risk prostate cancer. Following diagnostic biopsy the men were classified into 3 groups, including group 1-no magnetic resonance imaging, group 2-magnetic resonance imaging only and group 3-magnetic resonance imaging/post-magnetic resonance imaging biopsy. For the purposes of counseling and shared decision making magnetic resonance imaging results were deemed reassuring (PI-RADS™ [Prostate Imaging Reporting and Data System] 3 or less) or nonreassuring (PI-RADS 4 or greater). Similarly, if the diagnostic biopsy was GG (Grade Group) 1, post-magnetic resonance imaging biopsy results were deemed nonreassuring if there was any amount of GG 2 or greater. If the diagnostic biopsy was GG 2, post-magnetic resonance imaging biopsy results were deemed nonreassuring if more than 3 cores were GG 2, or there was more than 50% GG 2 in any individual core or any volume of GG 3 or greater. RESULTS: Of 1,461 men with favorable risk prostate cancer 1,223 (84%) did not undergo magnetic resonance imaging, 157 (11%) underwent magnetic resonance imaging alone and 81 (6%) underwent magnetic resonance imaging and post-magnetic resonance imaging biopsy. Of the men who underwent magnetic resonance imaging alone more with reassuring findings elected active surveillance than men with nonreassuring or magnetic resonance imaging findings (74% vs 35% and 42%, respectively). The highest rate of active surveillance was noted in men with reassuring post-magnetic resonance imaging biopsy regardless of whether magnetic resonance imaging was reassuring or nonreassuring (93% and 96%, respectively). CONCLUSIONS: Magnetic resonance imaging and post-magnetic resonance imaging biopsy drive decision making in men with newly diagnosed, favorable risk prostate cancer. Post-magnetic resonance imaging biopsy is a stronger driver of decision making than magnetic resonance imaging alone. This was demonstrated by the more than 90% of men with reassuring post-magnetic resonance imaging biopsies who elected active surveillance regardless of magnetic resonance imaging results.

Utilization of Salvage Radiation Therapy for Biochemical Recurrence After Radical Prostatectomy.

PURPOSE: For men with biochemical recurrence after radical prostatectomy (RP), salvage radiation therapy (SRT), especially "early" SRT (PSA level ≤0.5 ng/mL), is a potentially curative option; however, its utilization is not well defined. We sought to determine factors associated with SRT utilization as well as variation in its administration. MATERIALS AND METHODS: Patients with localized prostate cancer undergoing RP at 33 practices participating in the statewide Michigan Urological Surgery Improvement Collaborative between 2012 and 2016 were prospectively followed. Eligible patients had at least 1 post-RP PSA level ≥0.1 ng/mL with ≥6 months of follow-up after the first detectable PSA level. Patients undergoing adjuvant radiation therapy were excluded. SRT utilization and clinical and pathologic patient characteristics were examined. RESULTS: Of 1010 eligible patients with a detectable PSA level, 29.5% underwent SRT. Of patients who received SRT, 46.9% either reached a PSA ≥0.2 ng/mL or were treated before reaching that PSA level. A total of 30.6% of patients had a PSA level ≥0.5 ng/mL without undergoing prior SRT; of this group, 42.1% later received SRT. After adjusting for patient and practice level factors, positive surgical margins, higher T stage, and higher grade group were all associated with receipt of SRT (P < .05). Even after adjusting for patient and tumor characteristics, significant variation remained in the adjusted rate of SRT utilization across practices sites, ranging from 7% (95% confidence interval, 3%-17%) to 73% (95% confidence interval, 45%-90%, P < .001). Practices were grouped into tertiles based on SRT utilization, and those practices that used SRT more frequently overall were more likely to administer SRT across all patient-based predictors of SRT utilization. CONCLUSIONS: SRT utilization is low among men with a detectable post-RP PSA level, with significant variation in practice-level SRT utilization that cannot be explained by patient factors alone. Factors suggesting higher-risk disease were predictors of SRT administration. These data support the potential to expand the use of SRT, particularly among sites with low utilization.

Risk of Becoming Lost to Follow-up During Active Surveillance for Prostate Cancer.

Active surveillance (AS) has emerged as the preferred management strategy for many men with prostate cancer (PC); however, insufficient longitudinal monitoring may increase the risk of poor outcomes. We sought to determine rates of patients becoming lost to follow-up (LTFU) and associated risk factors in a large AS cohort. The Michigan Urologic Surgery Improvement Collaborative (MUSIC) maintains a prospective registry of PC patients from 44 academic and community urology practices. Over a 6-yr period (2011-2017), we identified patients managed with AS. LTFU was defined as any 18-mo period where no pertinent surveillance testing was entered in the registry. With a median surveillance period of 32 mo, the estimated 2-yr LTFU-free probability calculated by Kaplan-Meier method was 90% (95% confidence interval [CI]=89-92%). Both African American race (hazard ratio [HR]: 2.77, 95% CI=1.81-4.24) and Charlson comorbidity index ≥1 (HR: 1.55, 95% CI=1.08-2.23) were independently associated with increased risk of LTFU. There was variability in rates of estimated 2-yr LTFU-free survival across MUSIC practices, ranging from 52% (95% CI=21-100%) to 99% (95% CI=97-100%), with a median of 96% (interquartile range: 94-98%), although this did not reach statistical significance (p=0.076). These data reveal opportunities for urology practices to identify systems to reduce rates of LTFU and improve the long-term safety of AS. PATIENT SUMMARY: With a median observation period of 32 mo, an estimated 10% of patients will be lost to follow-up at the 2 yr time point while on AS. African American men and generally unhealthy patients were at increased risk, and there was variability from one urology practice to another. There is ample opportunity to improve the quality of the performance of AS.

A Statewide Intervention Improves Appropriate Imaging in Localized Prostate Cancer.

PURPOSE: We implemented a statewide intervention to improve imaging utilization for the staging of patients with newly diagnosed prostate cancer. MATERIALS AND METHODS: MUSIC (Michigan Urological Surgery Improvement Collaborative) is a quality improvement collaborative comprising 42 diverse practices representing approximately 85% of the urologists in Michigan. MUSIC has developed imaging appropriateness criteria (prostate specific antigen greater than 20 ng/ml, Gleason score 7 or higher and clinical stage T3 or higher) which minimize unnecessary imaging with bone scan and computerized tomography. After baseline rates of radiographic staging were established in 2012 and 2013, we used multidimensional interventions to deploy these criteria in 2014. Imaging utilization was then remeasured in 2015 to evaluate for changes in practice patterns. RESULTS: A total of 10,554 newly diagnosed patients with prostate cancer were entered into the MUSIC registry from January 1, 2012 through December 31, 2013 and January 1, 2015 through December 31, 2015. Of these patients 7,442 (79%) and 7,312 (78%) met our criteria to avoid bone scan and computerized tomography imaging, respectively. The use of bone scan imaging when not indicated decreased from 11.0% at baseline to 6.5% after interventions (p <0.0001). The use of computerized tomography when not indicated decreased from 14.7% at baseline to 7.7% after interventions (p <0.0001). Variability among practices decreased substantially after the interventions as well. The use of recommended imaging remained stable during these periods. CONCLUSIONS: An intervention aimed at appropriate use of imaging was associated with decreased use of bone scans and computerized tomography among men at low risk for metastases.

Identifying Drivers of Episode Cost Variation With Radical Prostatectomy.

OBJECTIVE: To describe total and component radical prostatectomy (RP) episode costs across a diverse set of hospitals in Michigan, and examine drivers of variation in such payments. METHODS: We identified Medicare and private payer patients undergoing RP from 2012 to 2014 from the claims-based registry maintained by the Michigan Value Collaborative, a statewide consortium that provides hospitals with price-standardized and risk-adjusted 90-day episode costs for common medical and surgical procedures. We divided hospitals into quartiles based on mean total episode cost for RP. Total episode costs were further classified into 4 payment categories: index hospitalization, professional services, readmissions, and postacute care. Component payments were then compared across high-cost and low-cost hospitals. RESULTS: We identified 3077 patients undergoing RP in 42 hospitals. Mean 90-day total episode cost was $14,614, ranging from $13,043 to $16,749 across quartiles (28.4% difference, P < .001). Overall variation in total episode cost was divided nearly equally among readmissions (29%), postacute care (29%), and professional payments (26%). We noted significantly higher readmission ($1442 vs $288, P = .03) and postacute care payments at high-cost hospitals ($1686 vs $522, P = .002). CONCLUSION: Significant variation exists in 90-day total episode costs for RP, suggesting a potential target for bundled payments and other care improvement efforts. Focused efforts on reducing variation in readmissions and postacute care could improve cost-efficiency.

Understanding the Use of Prostate Biopsy Among Men with Limited Life Expectancy in a Statewide Quality Improvement Collaborative.

BACKGROUND: The potential harms of a prostate cancer (PCa) diagnosis may outweigh its benefits in elderly men. OBJECTIVE: To assess the use of prostate biopsy in men with limited life expectancy (LE) within the practices comprising the Michigan Urological Surgery Improvement Collaborative (MUSIC). DESIGN, SETTING, AND PARTICIPANTS: MUSIC is a consortium of 42 practices and nearly 85% of the urologists in Michigan. From July 2013 to October 2014, clinical data were collected prospectively for all men undergoing prostate biopsy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We calculated comorbidity-adjusted LE in men aged ≥66 yr and identified men with <10 yr LE (limited LE) undergoing a first biopsy. Our LE calculator was not designed for men aged <66 yr; thus these men were excluded. Multivariable models estimated the proportion of all biopsies performed for men with limited LE in each MUSIC practice, adjusting for differences in patient characteristics. We also evaluated what treatments, if any, these patients received. RESULTS AND LIMITATIONS: Among 3035 men aged ≥66 yr undergoing initial prostate biopsy, 60% had none of the measured comorbidities. Overall, 547 men (18%) had limited LE. Compared with men with a longer LE, these men had significantly higher prostate-specific antigen levels and abnormal digital rectal examination findings. The adjusted proportion of biopsies performed for men with limited LE ranged from 3.8% to 39% across MUSIC practices (p < 0.001). PCa was diagnosed in 69% of men with limited LE; among this group, 74% received any active treatment. Of these men, 46% had high-grade cancer (Gleason score 8-10). CONCLUSIONS: Among a large and diverse group of urology practices, nearly 20% of prostate biopsies are performed in men with limited LE. These data provide useful context for quality improvement efforts aimed at optimizing patient selection for prostate biopsy. PATIENT SUMMARY: In this report, nearly 2 of every 10 men undergoing prostate biopsy had a life expectancy (LE) <10 yr. Implementing LE calculators in clinical practice may help refine patient selection for prostate biopsy.

Notable Outcomes and Trackable Events after Surgery: Evaluating an Uncomplicated Recovery after Radical Prostatectomy.

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.

Understanding the Performance of Active Surveillance Selection Criteria in Diverse Urology Practices.

PURPOSE: We used data from MUSIC (Michigan Urological Surgery Improvement Collaborative) to evaluate the performance of published selection criteria for active surveillance in diverse urology practice settings. MATERIALS AND METHODS: For several active surveillance guidelines we calculated the proportion of men meeting each set of selection criteria who actually entered active surveillance, defined as the sensitivity of the guideline. After identifying the most sensitive guideline for the entire cohort we compared demographic and tumor characteristics between patients who met this guideline and entered active surveillance, and those who received initial definitive therapy. RESULTS: Of 4,882 men with newly diagnosed prostate cancer 18% underwent active surveillance. When applied to the entire cohort, the sensitivity of published guidelines ranged from 49% in Toronto to 62% at Johns Hopkins. At a practice level the sensitivity of Johns Hopkins criteria varied widely from 27% to 84% (p <0.001). Compared with men undergoing active surveillance, those meeting Johns Hopkins criteria who received definitive therapy were younger (p <0.001) and more likely to have a positive family history (p = 0.003), lower prostate specific antigen (p <0.001), a greater number of positive cores (2 vs 1) on biopsy (p <0.001) and a higher cancer volume in positive core(s) (p = 0.002). CONCLUSIONS: The sensitivity of published active surveillance selection criteria varies widely across diverse urology practices. Among patients meeting the most stringent criteria those who received initial definitive therapy had characteristics suggesting greater cancer risk, underscoring the nuanced clinical factors that influence treatment decisions.

A Statewide Intervention to Reduce Hospitalizations after Prostate Biopsy.

PURPOSE: Recent data suggest that increasing rates of hospitalization after prostate biopsy are mainly due to infections from fluoroquinolone-resistant bacteria. We report the initial results of a statewide quality improvement intervention aimed at reducing infection related hospitalizations after transrectal prostate biopsy. MATERIALS AND METHODS: From March 2012 through May 2014 data on patient demographics, comorbidities, prophylactic antibiotics and post-biopsy complications were prospectively entered into an electronic registry by trained abstractors in 30 practices participating in the MUSIC. During this period each practice implemented one or both of the interventions aimed at addressing fluoroquinolone resistance, namely 1) use of rectal swab culture directed antibiotics or 2) augmented antibiotic prophylaxis with a second agent in addition to standard fluoroquinolone therapy. We identified all patients with an infection related hospitalization within 30 days after biopsy and validated these events with claims data for a subset of patients. We then compared the frequency of infection related hospitalizations before (5,028 biopsies) and after (4,087 biopsies) implementation of the quality improvement intervention. RESULTS: Overall the proportion of patients with infection related hospitalizations after prostate biopsy decreased by 53% from before to after implementation of the quality improvement intervention (1.19% before vs 0.56% after, p=0.002). Among post-implementation biopsies the rates of hospitalization were similar for patients receiving culture directed (0.47%) vs augmented (0.57%) prophylaxis. At a practice level the relative change in hospitalization rates varied from a 7.4% decrease to a 3.0% increase. Fourteen practices had no post-implementation hospitalizations. CONCLUSIONS: A statewide intervention aimed at addressing fluoroquinolone resistance reduced post-prostate biopsy infection related hospitalizations in Michigan by 53%.

Contemporary use of initial active surveillance among men in Michigan with low-risk prostate cancer.

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.

Clinical predictors and recommendations for staging computed tomography scan among men with prostate cancer.

OBJECTIVE: To identify clinical variables associated with a positive computed tomography (CT) scan and estimate the performance of imaging recommendations in patients from a diverse sample of urology practices. MATERIALS AND METHODS: This study comprised 2380 men with newly diagnosed prostate cancer seen at 28 practices in the Michigan Urological Surgery Improvement Collaborative from March 2012 through September 2013. Data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical T stage, total number of positive biopsy cores, whether or not the patient received a staging abdominal and/or pelvic CT scan, and CT scan result. We fit a multivariate logistic regression model to identify clinical variables associated with metastases detected by CT scan. We estimated the sensitivity and specificity of existing imaging recommendations. RESULTS: Among 643 men (27.4%) who underwent a staging CT scan, 62 men (9.6%) had a positive study. In the multivariate analysis, PSA, GS, and clinical T stage were independently associated with the occurrence of a positive CT scan (all P values <.05). The American Urological Association's Best Practice Statements' recommendations for imaging when PSA level >20 ng/mL or GS ≥ 8 or locally advanced cancer had a sensitivity of 87.3% and specificity of 82.6%. Compared with current practice, implementing this recommendation in the Michigan Urological Surgery Improvement Collaborative population was estimated to result in approximately 0.5% of positive study results being missed, and 26.1% of fewer study results overall. CONCLUSION: Successful implementation of CT imaging criterion of PSA level >20, GS ≥ 8, or clinical stage ≥ T3 would ensure that CT scans are performed for almost all men who would have positive study results while reducing the number of negative study results.

Toward better use of bone scans among men with early-stage prostate cancer.

OBJECTIVE: To evaluate the performance of published guidelines compared with that of current practice for radiographic staging of men with newly diagnosed prostate cancer. MATERIALS AND METHODS: Using data from the Michigan Urological Surgery Improvement Collaborative clinical registry, we identified 1509 men diagnosed with prostate cancer from March 2012 through June 2013. Clinical data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical trial stage, number of biopsy cores, and bone scan (BS) results. We then fit a multivariate logistic regression model to examine the association between clinical variables and the occurrence of bone metastases. Because some patients did not undergo BS, we used established methods to correct for verification bias and estimate the diagnostic accuracy of published guidelines. RESULTS: Among 416 men who received a BS, 48 (11.5%) had evidence of bone metastases. Patients with bone metastases were older, with higher PSA levels and GS (all P <.05). In multivariate analyses, PSA (P <.001) and GS (P = .004) were the only independent predictors of positive BS. Guidelines from the American Urological Association and the National Comprehensive Cancer Network demonstrated similar performance in detecting bone metastases in our population, with fewer negative study results than those of the European Association of Urology guideline. Applying the American Urological Association recommendations (ie, image when PSA level >20 ng/mL or GS ≥ 8) to current clinical practice, we estimate that <1% of positive study results would be missed, whereas the number of negative study results would be reduced by 38%. CONCLUSION: Based on current practice patterns, more uniform application of existing guidelines would ensure that BS is performed for almost all men with bone metastases, while avoiding many negative imaging studies.

Variation in prostate cancer detection rates in a statewide quality improvement collaborative.

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.

Infection related hospitalizations after prostate biopsy in a statewide quality improvement collaborative.

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.

Quality of Care in Urology and the Michigan Urological Surgery Improvement Collaborative.

INTRODUCTION: Collaboratives composed of surgeons or hospitals are an effective means to improve quality of care and value. Building on the success of the Collaborative Quality Initiatives program of BCBSM (Blue Cross and Blue Shield of Michigan) and Blue Care Network, MUSIC (Michigan Urological Surgery Improvement Collaborative) seeks to improve the quality of care for patients with prostate cancer across Michigan. METHODS: MUSIC was established in 2010. Support for data management and the coordinating center are provided by BCBSM. A private software vendor was selected to develop and support the web based data entry platform. RESULTS: MUSIC currently has 43 participating practices representing more than 200 urologists from diverse locations and practice types. Prospective data collection began in March 2011 and currently almost 9,000 cases of prostate biopsy or newly diagnosed prostate cancer have been entered in the registry. MUSIC priorities for quality improvement include fostering appropriate imaging for staging; making prostate biopsy more efficient and safe; improving outcomes after radical prostatectomy by tracking complications and patient reported outcomes, and providing collaborative learning in surgical technique; enhancing shared decision making between patients and providers; and evaluating the use of new oral antiandrogenic therapies. CONCLUSIONS: MUSIC provides a unique opportunity for quality improvement initiatives in urology. Acceptance by urologists in various practice settings has been robust and indicates a commitment by members to positively contribute to better urological care through a shared learning environment.