The Clinical Cell-Cycle Risk (CCR) Score Is Associated With Metastasis After Radiation Therapy and Provides Guidance on When to Forgo Combined Androgen Deprivation Therapy With Dose-Escalated Radiation.

PURPOSE: The clinical cell-cycle risk (CCR) score, which combines the University of California, San Francisco's Cancer of the Prostate Risk Assessment (CAPRA) and the cell cycle progression (CCP) molecular score, has been validated to be prognostic of disease progression for men with prostate cancer. This study evaluated the ability of the CCR score to prognosticate the risk of metastasis in men receiving dose-escalated radiation therapy (RT) with or without androgen deprivation therapy (ADT). METHODS AND MATERIALS: This retrospective, multi-institutional cohort study included men with localized National Comprehensive Cancer Network (NCCN) intermediate-, high-, and very high-risk prostate cancer (N = 741). Patients were treated with dose-escalated RT with or without ADT. The primary outcome was time to metastasis. RESULTS: The CCR score prognosticated metastasis with a hazard ratio (HR) per unit score of 2.22 (95% confidence interval [CI], 1.71-2.89; P < .001). The CCR score better prognosticated metastasis than NCCN risk group (CCR, P < .001; NCCN, P = .46), CAPRA score (CCR, P = .002; CAPRA, P = .59), or CCP score (CCR, P < .001; CCP, P = .59) alone. In bivariable analyses, CCR score remained highly prognostic when accounting for ADT versus no ADT (HR, 2.18; 95% CI, 1.61-2.96; P < .001), ADT duration as a continuous variable (HR, 2.11; 95% CI, 1.59-2.79; P < .001), or ADT given at or below the recommended duration for each NCCN risk group (HR, 2.19; 95% CI, 1.69-2.86; P < .001). Men with CCR scores below or above the multimodality threshold (CCR score, 2.112) had a 10-year risk of metastasis of 3.7% and 21.24%, respectively. Men with below-threshold scores receiving RT alone had a 10-year risk of metastasis of 3.7%, and for men receiving RT plus ADT, the 10-year risk of metastasis was also 3.7%. CONCLUSIONS: The CCR score accurately and precisely prognosticates metastasis and adds clinically actionable information relative to guideline-recommended therapies based on NCCN risk in men undergoing dose-escalated RT with or without ADT. For men with scores below the multimodality threshold, adding ADT may not significantly reduce their 10-year risk of metastasis.

The Cost of Prostate Biopsies and their Complications: A Summary of Data on All Medicare Fee-for-Service Patients over 2 Years.

INTRODUCTION: We define the cost of a contemporary prostate biopsy and the rate and incremental impact of complications on costs. METHODS: A retrospective analysis of all Medicare fee-for-service claims for prostate biopsies in the United States from January 31, 2014 to December 1, 2015 was performed. Costs of each biopsy episode (including 30 days after each biopsy) were calculated. The effects of complications, biopsy setting and subsequent inpatient hospitalization were explored. RESULTS: The average cost of the 234,819 biopsies reviewed was $2,020 and 46% of biopsy costs occurred in the 30 days following each biopsy. Biopsies performed in the office setting comprised 66% of the total and were least costly ($1,750) compared to biopsies performed in ambulatory surgical centers ($2,260) and outpatient hospital settings ($2,730, both p <0.001). Biopsies performed in the office setting were associated with fewer complications (10%) compared to the outpatient hospital (19%) or ambulatory surgical center settings (12%, both p <0.001). An uncomplicated biopsy episode cost an average of $1,740, which increased to $4,060 when at least 1 complication occurred (difference +$2,320, p <0.001). The largest charges incurred were related to inpatient admissions, which added $13,840 to the cost of a prostate biopsy (p <0.001) but were rare, constituting only 2.8% of biopsies. CONCLUSIONS: Nearly half of costs during prostate biopsy episodes occur due to complications that occur in the days following a biopsy. These data should be used as benchmarks to incentivize interventions to reduce complications and subsequent admissions following biopsies.

Weighted Gleason Grade Group (WGGG): A new prostate cancer biopsy reporting system with prognostic potential.

INTRODUCTION: Presently, prostate biopsy (PBx) results report the highest Gleason Grade Group (GGG) as a single metric that gauges the overall clinical aggressiveness of cancer and dictates treatment. We hypothesized a PBx showing multiple cores of cancer with more volume cancer per core would represent more aggressive disease. We propose the Weighted Gleason Grade Group (WGGG), a novel scoring system that synthesizes all histopathologic data and cancer volume into a single numeric value representing the entire PBx, allowing for improved prediction of adverse pathology and risk of biochemical recurrence (BCR) following radical prostatectomy (RP). METHODS: We studied 171 men who underwent RP after standard PBx. The WGGG was calculated by summing each positive core using the formula: GGG + (GGG x %Ca/core). RP pathology was evaluated for extraprostatic extension (EPE), positive surgical margins (PSM), seminal vesicle invasion (SVI), and lymph node involvement (LNI), and patients were followed for BCR. We compared GGG vs. WGGG receiver operating characteristic curves for each outcome, and determined the predictive capability of GGG and WGGG to identify patients with BCR. Categorized WGGG groups were created based on risk of BCR using classification and regression tree analysis. We then sought to externally validate WGGG in a cohort of 389 patients in a separate institutional dataset. RESULTS: In the development cohort, area under the curves (AUCs) for the WGGG vs. GGG were significantly higher for predicting EPE (0.784 vs. 0.690, P = 0.002), SVI (AUC 0.823 vs. 0.721, P = .014), LNI (AUC 0.862 vs. 0.823, P = 0.039), and PSM (AUC 0.638 vs. 0.575, P = 0.031. Analysis of the validation cohort showed similar findings for EPE (AUC 0.764 vs. 0.729, P = 0.13), SVI (AUC 0.819 vs. 0.749, P = 0.01), LNI (AUC 0.939 vs. 0.867, P = 0.02), and PSM (AUC 0.624 vs. 0.547, P = 0.04). Patients with WGGG >30 (high-risk group) demonstrated ∼50% failure at 2 years in both cohorts. CONCLUSIONS: The WGGG, by providing a metric reflecting the entirety of the PBx, is more informative than conventional single GGG alone in identifying adverse pathologic outcomes and risk of BCR following RP. This superior discriminatory capability has been achieved without any consideration of other commonly available clinical disease characteristics.

The Effect of Local Antibiogram-based Augmented Antibiotic Prophylaxis on Infection-related Complications Following Prostate Biopsy.

Given the number of prostate biopsies performed annually in the United States and associated infectious events as a result, we sought to determine if implementation of a standardized biopsy protocol utilizing antibiotic prophylaxis based on locally derived antibiograms would result in a decrease, relative to a contemporary control population, in the incidence of infection-related complications among community-based practices. A total of nine member groups of LUGPA participated in both a retrospective review and a prospective study of infection-related complications following prostate biopsy. Historic infectious complications, defined as chills/rigor, temperature higher than 101 °F, or documented positive blood or urine cultures, were self-reported by a retrospective review of patients undergoing prostate biopsy under the practice's current protocol in the year prior to the study. The prospective phase of the study required each group to develop a locally derived augmented prophylaxis regimen (>2 antibiotics) based on local antibiograms. After implementation, the practices enrolled patients undergoing prostate biopsy over an 8-week period. Monitoring for infection-related complication took place over the ensuing 3 weeks post-biopsy. Seven hundred fifty-nine patients over nine practices were enrolled into the study utilizing the augmented locally determined prophylaxis protocol. There was a 53% reduction in the incidence of infection-related complication, relative to the historical rate. By developing a standardized biopsy protocol with specific emphasis on incorporating an augmented antibiotic prophylactic regimen based upon local antibiograms, we were able to demonstrate in a prospective trial across nine geographically distinct community practices a significant reduction in the incidence of infection-related complications.

The LUGPA Alternative Payment Model for Initial Therapy of Newly Diagnosed Patients With Organ-confined Prostate Cancer: Rationale and Development.

Over the past several decades, rapid expansion in healthcare expenditures has exposed the utilization incentives inherent in fee-for-service payment models. The passage of Medicare Access and CHIP Reauthorization Act of 2015 heralded a transition toward value-based care, creating incentives for practitioners to accept bidirectional risk linked to outcome and utilization metrics. At present, the limited availability of these vehicles excludes all but a handful of providers from participation in alternative payment models (APMs). The LUGPA APM supports the goals of the triple aim in improving the patient experience, enhancing population health and reducing expenditures. By requiring utilization of certified electronic health record technologies, tying payment to quality metrics, and requiring practices to bear more than nominal risk, the LUGPA APM qualifies as an advanced APM, thereby easing the reporting burden and creating opportunities for participating practices.

Factors associated with emotional distress in newly diagnosed prostate cancer patients.

OBJECTIVE: Early identification and intervention have been recommended for newly diagnosed prostate cancer patients who experience significant emotional distress; however, there is little empirical basis for designing or selecting interventions for these men. We sought to identify factors that are associated with distress in these men as a basis for identifying suitable intervention strategies. METHODS: Using cross-sectional data and validated scales, we investigated the extent to which clinical, demographic, belief, and personality characteristics are associated with emotional distress assessed with the Distress Thermometer in 1425 men newly diagnosed with clinically localized prostate cancer (pretreatment). RESULTS: Beliefs potentially amenable to psychoeducational interventions [low self-efficacy for decision-making (B =-0.11, p = 0.02), low confidence in cancer control (B =-0.03, p < 0.001), and masculine identity threat (B =-0.26, p = 0.001)] were associated with higher emotional distress, as well as personality factors [low optimism (B =-0.04, p = 0.052) and low resilience (B =-0.83, p < 0.001)]. CONCLUSIONS: Findings provide a framework for the development of interventions for prostate cancer patients with elevated emotional distress. These may include improving provider communication about prostate cancer prognosis for those with low confidence in cancer control, providing decision-making support to increase decision-making self-efficacy, or referral to brief cognitive behavioral interventions to help patients reframe masculine identity threat or for those with low optimism or resilience reframe and adjust to the health threat.

AUA Quality Improvement Summit 2014: Conference Proceedings on Infectious Complications of Transrectal Prostate Needle Biopsy.

INTRODUCTION: The AUA Quality Improvement Summit is a continuing AUA effort to provide education around issues related to quality improvement and patient safety. Due to the rapidly increasing rates of hospitalization following prostate needle biopsy, Infectious Complications of Transrectal Prostate Needle Biopsy was selected as the inaugural topic. METHODS: The information is largely unpublished data provided by the presenting physicians. Infection rates are predominantly self-reported with protocols specified by the physicians' home institutions. Beyond the identified speakers, the open forum of this summit allowed for input from a majority of the participants. RESULTS: Current hospitalization rates for transrectal prostate needle biopsy infections vary widely from 0.5% to 6%. Antibiotic resistance of coliform organisms appears to be a major risk of these infectious complications. Prophylactic protocols also vary widely among the represented institutions. Antibiotic resistance profiles showed extreme regional variation and, as such, a prophylactic antibiotic protocol should be based on the current local antibiogram in order to reduce infection rates. Opinions vary in relation to the specific antibiotics appropriate for an augmented antibiotic prophylaxis, in the use of rectal swab and prebiopsy enema, and povidone-iodine preparation of the rectal vault. Standardization of the transrectal antibiotic prophylaxis across practices has been proven to reduce the infectious complications rates. CONCLUSIONS: Urologists should monitor the prostate biopsy infection rates of the practice and consult the current local antibiogram. Physicians should query patients to assess whether they are at high risk for resistant organisms. If so, prophylactic protocols might be intensified.

Utilization trends and positive biopsy rates for prostate biopsies in the United States: 2005 to 2011.

This article assesses the positive biopsy rate and core sampling pattern in patients undergoing needle biopsy of the prostate in the United States at a national reference laboratory (NRL) and anatomic pathology laboratories integrated into urology group practices, and analyzes the relationship between positive biopsy rates and the number of specimen vials per biopsy. For the years 2005 to 2011 we collected pathology data from an NRL, including number of urologists and urology practices referring samples, total specimen vials submitted for prostate biopsies, and final pathologic diagnosis for each case. The diagnoses were categorized as benign, malignant, prostatic intraepithelial neoplasia, or atypical small acinar proliferation. Over the same period, similar data were gathered from urology practices with in-house laboratories performing global pathology services (urology practice laboratories; UPLs) as identified by a survey of members of the Large Urology Group Practice Association. For each year studied, positive biopsy rate and number of specimen vials per biopsy were calculated in aggregate and separately for each site of service. From 2005 to 2011, 437,937 biopsies were submitted in > 4.23 million vials (9.4 specimen vials/biopsy); overall positive biopsy rate was 40.3%-this was identical at both the NRL and UPL (P = .97). Nationally, the number of specimen vials per biopsy increased sharply from a mean of 8.8 during 2005 to 2008 to a mean of 10.3 from 2009 to 2011 (difference, 1.5 specimen vials/biopsy; P = .03). For the most recent 3-year period (2009-2011), the difference of 0.6 specimen vials per biopsy between the NRL (10.0) and UPL (10.6) was not significant (P = 0.08). Positive biopsy rate correlated strongly (P < .01) with number of specimen vials per biopsy. The positive prostate biopsy rate is 40.3% and is identical across sites of service. Although there was a national trend toward increased specimen vials per biopsy from 2005 to 2011, from 2009 to 2011 there was no significant difference in specimen vials per biopsy across sites of service. Increased cancer detection rate correlated significantly with increased number of specimens examined. Segregation of prostate biopsy cores into 10 to 12 unique specimen vials has been widely adopted by urologists across sites of service.

Utilization trends in prostate cancer therapy.

PURPOSE: We determined therapeutic trends in the management of adenocarcinoma of the prostate, and in the case of intensity modulated radiation therapy we investigated whether site of service influenced those trends. MATERIALS AND METHODS: A variety of CPT codes to treat adenocarcinoma of the prostate were extracted from the Medicare Part B 5% sample for the years 2006 to 2008 inclusive. Data were stratified by year, type of service and, in the case of radiation therapy, site of service. Treatment trends were calculated by indexing the total number of Medicare beneficiaries receiving a service against needle biopsies of the prostate. RESULTS: The percentage of Medicare beneficiaries receiving therapy indexed to needle biopsies of the prostate increased from 43.8% in 2006 to 49.0% in 2008. Trends in radiation and surgery were similar with 11.5% and 13% increases in each modality, respectively. Total Medicare beneficiaries receiving intensity modulated radiation therapy and laparoscopic radical prostatectomy increased by 25.4% and 22.1%, respectively, while Medicare beneficiaries treated with open radical prostatectomy and 3-dimensional conformal radiation therapy decreased by 27.9% and 37.6%, respectively. The pattern of use for intensity modulated radiation therapy was similar in physician office and hospital facility settings, increasing from 7.3% to 11.1% and 8.3% to 11.3% of Medicare beneficiaries indexed to needle biopsies of the prostate receiving intensity modulated radiation therapy at these sites in 2008, respectively. CONCLUSIONS: Treatment trends in surgery and radiation strongly favor newer technologies, and in the case of intensity modulated radiation therapy, utilization trends for treatment of adenocarcinoma of the prostate are similar across all sites of service.