Faculty Bibliography

BACKGROUND:Accurate assessment of life expectancy (LE) is critical to treatment decision making for men with prostate cancer. We sought to externally validate the Prostate Cancer Comorbidity Index (PCCI) for prediction of long-term mortality in men with prostate cancer and operationalize it using claims data. METHODS:We conducted an observational study of 181,009 men with prostate cancer from the Veterans Affairs Health System diagnosed from 2000-2013. Overall mortality across PCCI scores was analyzed using Kaplan-Meier and Cox proportional hazards analysis. Discrimination and calibration were measured using c-index and mean prediction error, respectively. RESULTS:Among men with PCCI scores of 0, 1-2, 3-4, 5-6, 7-9, and 10+, 10-year overall mortality was 15%, 26%, 36%, 41%, 52%, and 69%, respectively. Multivariable Cox analysis showed an increasing hazard of mortality (95%CI) with higher PCCI scores: 1.22 (1.18-1.27), 1.69 (1.61-1.76), 2.08 (2.00-2.17), 2.88 (2.76-3.00), 4.50 (4.32-4.69) for scores of 1-2, 3-4, 5-6, 7-9, and 10+, respectively. C-index for prediction of overall mortality was 0.773. Mean absolute error for prediction of 10-year overall mortality was 0.032. Among men with clinically localized, Gleason ≤6 disease with LE<10 years and Gleason ≤7 disease with LE<5 years as defined by the PCCI, 3,999/12,185 (33%) and 1,038/3,930 (26%) men were treated with definitive local treatment, respectively. CONCLUSIONS:The PCCI is a claims-based, externally validated tool that predicts mortality in men with prostate cancer. Integration of the PCCI into clinical pathways may improve prostate cancer management through more accurate LE assessment.

Prostate cancer screening reduces advanced disease and prostate cancer death but is controversial due to downstream harms including unnecessary biopsies and overtreatment. In 2012 the United States Preventive Services Task Force (USPSTF) recommended against screening men for prostate cancer, a practice common since the early 1990's. This dramatic policy change was opposed by many physicians and patient groups. Our group reported on the Twitter response within 24 hours of these guidelines, showing a missed opportunity for greater advocacy since the majority of tweets did not express an opinion.

INTRODUCTION/BACKGROUND:According to current National Comprehensive Cancer Network guidelines, routine imagining for staging low-risk prostate cancer is not recommended. However, extensive overuse of guideline-discordant imaging continues to persist. Incidental findings are common on imaging and little is known about the optimal management. Rates of incidental findings vs. false positive diagnosis from inappropriate imaging are poorly understood and have yet to be quantified for low- and intermediate-risk prostate cancer patients. OBJECTIVE:To determine the frequency of positive radiologic findings in patients with low- and intermediate-risk prostate cancer during initial staging at VA New York Harbor Healthcare System. METHODS:We retrospectively reviewed all low- and intermediate-risk prostate cancer patients' medical records from the VA New York Harbor Healthcare System for diagnosis from 2005 to 2015. We reviewed each individual's prebiopsy prostate specific antigen (PSA), Gleason score, and clinical stage. We also determined if imaging obtained yielded a false positive, incidental finding, or if metastatic disease occurred within the 6 months following initial diagnosis. RESULTS:There were 414 men, who were classified as low- to intermediate-risk prostate cancer and underwent inappropriate staging imaging of 4,306 men diagnosed with prostate cancer. Of these 414 men, 178 (43%) had additional follow-up imaging for positive findings. We calculated an incidental finding rate of 10% and a false positive rate of 38% for patients. Five (1%) patients had metastatic disease. CONCLUSION/CONCLUSIONS:Despite guideline recommendations, imaging overuse remains an issue for low-intermediate-risk prostate cancer patients. The false positive rate found in this analysis is alarmingly high at 38%. This use of scans is burdensome to the healthcare system and patient. This study highlights the frequency of inappropriate imaging and its negative consequences.

INTRODUCTION/BACKGROUND:Disparities in survival for bladder and kidney cancer among the genders and patients with varying insurance coverage have been identified. Microhematuria (MH), a potential early clinical sign of genitourinary malignancy, should prompt a standardized diagnostic evaluation. However, many patients do not complete a full evaluation and may be at risk of a missed or delayed identification of genitourinary pathology. METHODS:Patients 35 and older with a new diagnosis of MH between 2007 and 2015 were retrospectively identified at a large health system. Our primary outcome of interest was completion of cystoscopy and imaging. Regression modeling was used to assess associations between gender and insurance status with completion of a MH evaluation, adjusted for clinical factors, urinalysis data, and patient demographics. RESULTS:Of 15,161 patients with MH, only 1,273 patients (8.4%) completed upper tract imaging and a cystoscopy; 899 (5.9%) within 1 year. Median time to imaging was 75 days and 68.5 days for cystoscopy. Of those with an incomplete evaluation, 23.7% underwent cystoscopy and 76.3% underwent imaging. Male gender, private insurance, and increased MH severity on UA were associated with a complete evaluation. More patients who completed an evaluation were diagnosed with bladder (4.8% vs. 0.3%) and kidney cancer (3.1% vs. 0.4%) when compared to those who did not. CONCLUSION/CONCLUSIONS:Few patients complete a timely evaluation of MH. Women and underinsured patients are disproportionately less likely to complete a work-up for microhematuria and this may have downstream implications for diagnosis.

OBJECTIVES/OBJECTIVE:To characterize bone scan use, and potential overuse, after radical prostatectomy using a large, national integrated delivery system. Overuse of imaging is well documented in the setting of newly diagnosed prostate cancer, but whether overuse persists following radical prostatectomy remains unknown. MATERIALS AND METHODS/METHODS:We identified 12,269 prostate cancer patients treated with radical prostatectomy between 2005-2008 using the Veterans Administration Central Cancer Registry. We used administrative and laboratory data to examine rates of bone scan use, including preceding PSA levels, and receipt of adjuvant or salvage therapy. We then performed multivariable logistic regression to identify factors associated with post-prostatectomy bone scan use. RESULTS:At a median follow up of 6.8 years, one in five men (22%) underwent a postoperative bone scan at a median PSA of 0.2 ng/mL. Half of bone scans (48%) were obtained in men who did not receive further treatment with androgen deprivation (ADT) or radiation therapy. After adjustment, post-prostatectomy bone scan was associated with a prior bone scan (adjusted Odds Ratio (aOR) 1.55, 95% Confidence Interval (CI) 1.32 - 1.84), positive surgical margin (aOR 1.68, 95% CI 1.40 - 2.01), preoperative PSA (aOR 1.02, 95% CI 1.01 - 1.03) as well as Hispanic ethnicity, black race, and increasing D'Amico risk category, but not with age or comorbidity. CONCLUSION/CONCLUSIONS:We found a substantial rate of bone scan utilization after radical prostatectomy. The majority was performed for PSA <1ng/mL where the likelihood of a positive test is low. More judicious use of imaging appears warranted in the post-prostatectomy setting.

PURPOSE/OBJECTIVE:This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented herein represents Part II of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. Please refer to Part I for discussion of specific care options and outcome expectations and management. MATERIALS AND METHODS/METHODS:The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS:The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS:This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

PURPOSE/OBJECTIVE:This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented represents Part I of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. MATERIALS AND METHODS/METHODS:The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS:The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS:This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

Importance/UNASSIGNED:Prostate cancer imaging rates appear to vary by health care setting. With the recent extension of the Veterans Access, Choice, and Accountability Act, the government has provided funds for veterans to seek care outside the Veterans Health Administration (VA). It is important to understand the difference in imaging rates and subsequent differences in patterns of care in the VA vs a traditional fee-for-service setting such as Medicare. Objective/UNASSIGNED:To assess the association between prostate cancer imaging rates and a VA vs fee-for-service health care setting. Design, Setting, and Participants/UNASSIGNED:This cohort study included data for men who received a diagnosis of prostate cancer from January 1, 2004, through March 31, 2008, that were collected from the VA Central Cancer Registry, linked to administrate claims and Medicare utilization records, and the Surveillance, Epidemiology, and End Results Program database. Three distinct nationally representative cohorts were constructed (use of VA only, use of Medicare only, and dual use of VA and Medicare). Men older than 85 years at diagnosis and men without high-risk features but missing any tumor risk characteristic (prostate-specific antigen, Gleason grade, or clinical stage) were excluded. Analysis of the data was completed from March 2016 to February 2018. Exposures/UNASSIGNED:Patient utilization of different health care delivery systems. Main Outcomes and Measures/UNASSIGNED:Rates of prostate cancer imaging were analyzed by health care setting (Medicare only, VA and Medicare, and VA only) among patients with low-risk prostate cancer and patients with high-risk prostate cancer. Results/UNASSIGNED:Of 98 867 men with prostate cancer (77.4% white; mean [SD] age, 70.26 [7.48] years) in the study cohort, 57.3% were in the Medicare-only group, 14.5% in the VA and Medicare group, and 28.1% in the VA-only group. Among men with low-risk prostate cancer, the Medicare-only group had the highest rate of guideline-discordant imaging (52.5%), followed by the VA and Medicare group (50.9%) and the VA-only group (45.9%) (P < .001). Imaging rates for men with high-risk prostate cancer were not significantly different among the 3 groups. Multivariable analysis showed that individuals in the VA and Medicare group (risk ratio [RR], 0.87; 95% CI, 0.76-0.98) and VA-only group (RR, 0.79; 95% CI, 0.67-0.92) were less likely to receive guideline-discordant imaging than those in the Medicare-only group. Conclusions and Relevance/UNASSIGNED:The results of this study suggest that patients with prostate cancer who use Medicare rather than the VA for health care could experience more utilization of health care services without an improvement in the quality of care.

BACKGROUND:Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial. METHODS/DESIGN/METHODS:This innovative mixed methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the theoretical domains framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. DISCUSSION/CONCLUSIONS:Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT03579680 , First Posted July 6, 2018.