Original Research - Reviews in Urology

All articles from this category are listed below.

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 5 .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 5 .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 5 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. [Rev Urol. 2013;15(4):137-144 doi: 10.3909/riu0600] © 2014 MedReviews®, LLC

Prostate cancer Prostate biopsy Utilization trends National reference laboratory

Volume 17, Number 4 Original Research

The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices

Stephen M Zappala Dipen J Parekh Badrinath R Konety Kenneth M Kernen Gregory M Oldford Randy M Chudler Jeffrey Schock Danielle Osterhout Jason Hafron

There is significant concern regarding prostate cancer screening because of the potential for overdiagnosis and overtreatment of men who are discovered to have abnormal prostate specific antigen (PSA) levels and/or digital rectal examination (DRE) results. The 4Kscore® Test (OPKO Diagnostics, LLC) is a blood test that utilizes four kallikrein levels plus clinical information in an algorithm to calculate an individual’s percentage risk (< 1% to > 95%) for aggressive prostate cancer (Gleason score ≥ 7) on prostate biopsy. The 4Kscore Test, as a follow-up test after abnormal PSA and/or DRE test results, has been shown to improve the specificity for predicting the risk of aggressive prostate cancer and reduce unnecessary prostate biopsies. A clinical utility study was conducted to assess the influence of the 4Kscore Test on the decision to perform prostate biopsies in men referred to urologists for abnormal PSA and/or DRE results. The study population included 611 patients seen by 35 academic and community urologists in the United States. Urologists ordered the 4Kscore Test as part of their assessment of men referred for abnormal PSA and/or DRE test results. Results for the patients were stratified into low risk (< 7.5%), intermediate risk (7.5%-19.9%), and high risk (≥ 20%) for aggressive prostate cancer. The 4Kscore Test results influenced biopsy decisions in 88.7% of the men. Performing the 4Kscore Test resulted in a 64.6% reduction in prostate biopsies in patients; the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19.0% for men who had low-, intermediate-, and high-risk 4Kscore Test results, respectively. A higher 4Kscore Test was associated with greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 patients who had a biopsy, the 4Kscore risk category is strongly associated with biopsy pathology. The 4Kscore Test, as a follow-up test for an abnormal PSA and/or DRE results, significantly influenced the physician and patient shared decision in clinical practice, which led to a reduction in prostate biopsies while increasing the probability of detecting aggressive cancer. [Rev Urol. 2015;17(4):231-240 doi: 10.3909/riu0699] © 2016 MedReviews®, LLC

Prostate cancer Prostate-specific antigen 4Kscore Gleason score Digital rectal examination Biopsy rate Prostate cancer prognosis

Volume 17, Number 1 Original Research

Hemostasis During Urologic Surgery: Fibrin Sealant Compared With Absorbable Hemostat

Jonathan Batiller Liza Ovington Jessica Shen John Albanese Bogdan Ilie Richard Kocharian Jerome B Riebman David M. Albala

In the United States, fibrin sealants have been used to achieve hemostasis for nearly two decades. Although their clinical utility was first demonstrated in cardiac surgery, their effectiveness and safety have since been demonstrated to extend to a wide array of procedures. Fibrin sealants typically contain two components—fibrinogen and thrombin—that are combined and delivered simultaneously to a target bleeding site in order to achieve hemostasis. However, many commercial formulations contain other additional components, such as antifibrinolytic agents, that have been associated with adverse outcomes. This subanalysis compares the safety and effectiveness of a fibrin sealant versus an absorbable hemostat for achieving hemostasis during urologic procedures with mild to moderate bleeding. [Rev Urol. 2015;17(1):25-30 doi: 10.3909/ricm0647] © 2015 MedReviews®, LLC

Bleeding Hemostasis Hemostatics Fibrin tissue adhesive Urologic surgical procedures Surgical technique

Volume 18, Number 3 Original Research

Health Economic Impact and Prospective Clinical Utility of Oncotype DX® Genomic Prostate Score

Alan W Shindel Marybeth McCall Bela Denes Dylan Stoy Vincy John Ruixiao Lu David Albala Frank Dubeck Michael J Kemeter Phillip G Febbo

Prostate cancer (CaP) will be diagnosed in approximately 181,000 American men in 2016. Despite the high number of deaths from CaP in the United States, the disease has a protracted natural history and many men diagnosed with CaP will not die of the disease regardless of treatment. Unfortunately, identification of men with truly indolent/nonaggressive CaP is challenging; limitations of conventional diagnostic modalities diminish the ability of physicians to accurately stage every case of CaP based on biopsy results alone. The resulting uncertainty in prognosis may prompt men with low-risk CaP to proceed to morbid and expensive treatments for an unclear survival benefit. Incorporation of the Genomic Prostate Score (GPS) as part of the decision algorithm for patients with National Comprehensive Cancer Network very low-risk and low-risk cancer led to a substantial increase in uptake of active surveillance and substantial cost savings. GPS provides physicians and patients with an additional tool in assessing personalized risk and helps guide individual decision making. [Rev Urol. 2016;18(3):123-132 doi: 10.3909/riu0725] © 2016 MedReviews®, LLC

Prostate cancer Oncotype DX® GPS Genomic testing Health economics Clinical utility

Volume 20, Number 1 Original Research

Transrectal Ultrasound–guided Versus Transperineal Mapping Prostate Biopsy: Complication Comparison

Transrectal ultrasound guided prostate biopsy • Transperieneal mapping prostate biopsy • Complications

Nelson N Stone George Zacharopoulos Michael Skouteris Marios Panagiotis Metsinis Paul Arangua Vassilios M Skouteris E David Crawford Vladimir Mouraviev

Herein, the authors compare morbidity in men who underwent both transrectal ultrasound–guided (TRUS) prostate biopsy and transperineal mapping biopsy (TPMB) at two institutions with extensive experience in both procedures. We also identified strategies and predictive factors to reduce morbidity for both procedures. In our study, 379 men from two institutions, of which 265 (69.9%) had a prior TRUS-guided biopsy, also had TPMB performed via a template with biopsies taken at 5-mm intervals. Men in the TRUS group had a median of 12 cores sampled whereas the TPMB group had 51.5 (range, 16-151). The median biopsy density was 1.1 core/cc prostate volume. Median age and prostate-specific antigen (PSA) level were 65 years (range, 34-86) and 5.5 ng/mL (range, 0.02-118). Of these men, 11 of 265 (4.2%) who had TRUS biopsy developed urinary tract infection compared with 3 of 379 (0.79%) of those with mapping biopsy. Infection was 14.8% in TRUS biopsy group with 13 or more cores versus 2.9% in those with 12 or less (OR, 5.8; 95% CI, 1.6-21.2; P = 0.003). No men developed retention after TRUS biopsy whereas 30 of 379 (7.9%) did following TPMB. Older age, larger prostate volume (PV), and higher core number were associated with retention. On linear regression only age (P = 0.010) and PV (P = 0.016) remained as significant associations. Men older than 65 years had 12.8% versus 3.9% (OR, 3.7; 95% CI, 1.6-8.4, P = 0.001) and PV greater than 42 cc had 13.4% versus 2.7% (OR, 5.7; 95% CI, 2.1-15.1) retention incidence. In the present study TPMB is rarely associated with infection (0.78%) but more commonly with urinary retention (7.9%). Men older than 65 years and with PV greater than 42 cc were at four to five times greater retention risk. Consideration should be given to discharging these men with a urinary catheter following TPMB. [Rev Urol. 2018;20(1):19–25 doi: 10.3909/riu0785] © 2018 MedReviews, LLC®

Complications Transrectal ultrasound guided prostate biopsy Transperieneal mapping prostate biopsy

Volume 20, Number 2 Original Research

Prostate Biopsy Characteristics: A Comparison Between the Pre- and Post-2012 United States Preventive Services Task Force (USPSTF) Prostate Cancer Screening Guidelines

Thomas Huebner Vladimir Ioffe Navin Shah Ivelina Hristova

To compare prostate cancer (PCa) characteristics diagnosed by prostate biopsy (Pbx) in the 3 years before and after the 2012 United States Preventive Services Task Force (USPSTF) recommendations for PCa screening, we completed a retrospective comparative analysis of 402 sequential PCa patients diagnosed from 2010 to 2012 (3 years) with 552 PCa patients diagnosed from 2015 to 2017 (3 years). Data was collected on patient age, race, total number of biopsies performed, prostate specific antigen (PSA), Gleason sum score (GSS), and digital rectal examination (DRE). The data was analyzed to determine whether the 2012 USPSTF screening recommendations affected PCa characteristics. Two study groups were defined, Group A and Group B, prior to and after the 2012 USPSTF screening recommendations, respectively. In Group A (pre- 2012 USPSTF recommendations), 567 patients/year underwent a Pbx versus Group B, 398 patients/year, a 30% reduction post-USPSTF. The annual positive Pbx rate for Group A is 134/year versus Group B 184/year, a 37.3% increase post-USPSTF. Group A had high-grade PCa (GSS 7-10) in 51.5% versus Group B in 60.1%, an 8.6% increase post-USPSTF. In Group B, the total number of positive biopsies was increased by 100%. This study shows that in Group B, the Pbx rate decreased by 30% but the annual PCa detection rate increased by 37%. High-grade GSS (7-10) PCa increased by 8.6%. Despite a reduction in the total number of prostate biopsies by 30%, there was a 100% increase in the total number of positive prostate biopsies. [Rev Urol. 2018;20(2):77–83 doi: 10.3909/riu0793] © 2018 MedReviews®, LLC

Prostate cancer United States Preventive Services Task Force PSA screening

Volume 20, Number 2 Original Research

Balancing Confounding and Generalizability Using Observational, Real-world Data: 17-gene Genomic Prostate Score Assay Effect on Active Surveillance

Michael J Kemeter Phillip G Febbo Steven Canfield John Hornberger

Randomized, controlled trials can provide high-quality, unbiased evidence for therapeutic interventions but are not always a practical or viable study design for certain healthcare decisions, such as those involving prognostic or predictive testing. Studies using large, real-world databases may be more appropriate and more generalizable to the intended target population of physicians and patients to answer these questions but carry potential for hidden bias. We illustrate several emerging methods of analyzing observational studies using propensity score matching (PSM) and coarsened exact matching (CEM). These advanced statistical methods are intended to reveal a “hidden experiment” within an observational database, and so refute or confirm a potential causal effect of assignment to an intervention and study outcome. We applied these methods to the Optum™ Research Database (ORD; Eden Prairie, MN) of electronic health records and administrative claims data to assess the effect of the 17-gene Genomic Prostate Score® (GPS™; Genomic Health, Redwood City, CA) assay on use of active surveillance (AS). In a traditional multivariable logistic regression, the GPS assay increased the use of AS by 29% (95% CI, 24%-33%). Upon applying the matching methods, the effect of the GPS assay on AS use varied between 27% and 80% and the matched data were significant among all algorithms. All matching algorithms performed well in identifying matched data that improved the imbalance in baseline covariates. By using different matching methods to assess causal inference in an observational database, we provide further confidence that the effect of the GPS assay on AS use is statistically significant and unlikely to be a result of confounding due to differences in baseline characteristics of the patients or the settings in which they were seen. [Rev Urol. 2018;20(2):69–76 doi: 10.3909/riu0799] © 2018 MedReviews, LLC®

Prostate cancer Active surveillance Evidence-based practice Comparative effectiveness research Genomic biomarker Propensity score Matching

Volume 20, Number 2 Original Research

Effectiveness of Subcutaneously Administered Leuprolide Acetate to Achieve Low Nadir Testosterone in Prostate Cancer Patients

Stuart Atkinson Scott Eggener Christopher M Pieczonka Jason Hafron Joseph Renzulli II Przemyslaw Twardowskim Deborah M Boldt-Houle

Evidence suggests lower nadir testosterone levels during the first year of androgen deprivation therapy improve advanced prostate cancer clinical outcomes. We evaluated pivotal trials for subcutaneously administered leuprolide acetate (1-, 3-, 4-, and 6-month doses) to determine nadir testosterone levels. Pooled analysis showed 99%, 97%, and 91% of patients reached nadir testosterone ≤20, ≤10, and ≤5 ng/dL respectively (median ≤3 ng/dL). Across all available categories, ≥88% of patients reached nadir testosterone ≤5 ng/dL, and <3% experienced a microsurge. Achievement and maintenance of low nadir testosterone levels may improve progression-free survival and time to onset of castrate-resistant prostate cancer. [Rev Urol. 2018;20(2):63–68 doi: 10.3909/riu0798] © 2018 MedReviews®, LLC

Prostate cancer Androgen deprivation therapy LHRH agonists Leuprolide acetate Nadir testosterone

Volume 20, Number 3 Original Research

Histologic Changes in Prostate Cancer Detected Subsequent to the 2012 United States Preventive Services Task Force (USPSTF) Prostate Cancer Screening Recommendation

Hugh J Lavery Carl A Olsson Deepak Kapoor Ann E Anderson

We report changes in the histopathology of prostate cancer diagnosed in a large urology group practice after the final United States Preventive Services Task Force (USPSTF) Grade D recommendation against prostate-specific antigen screening. All prostate biopsies performed from 2011 through 2015 in a large urology group practice were retrospectively reviewed; 2012 was excluded as a transition year. The changes in biopsy data in years following the USPSTF decision (2013-2015) were then compared with baseline (2011). A total of 10,944 biopsies were evaluated during the study period. Positive biopsy rates rose from 39.1% at baseline to 45.2% in 2015 (P < 0.01) with a marked shift toward more aggressive cancer throughout the study period. The absolute number of patients presenting with Gleason Grade Group 4 or 5 increased from 155/year at baseline to 231, 297, and 285 in 2013, 2014, and 2015, respectively (P < 0.05), unrelated to age or racial changes over time. Black men represented 16% of the cohort. Since the USPSTF recommendation against prostate cancer screening, trends toward a substantial upward grade migration and increased volume of cancers were noted in a cohort of nearly 11,000 patients in a real- world clinical practice. Additionally, continuing reductions in cancer detection in the United States may exacerbate these trends. [Rev Urol. 2018;20(3):125–130 doi: 10.3909/riu0815] © 2018 MedReviews®, LLC

Prostate cancer Prostate cancer screening Histopathology grade migration

Volume 20, Number 3 Original Research

Accuracy in 24-hour Urine Collection at a Tertiary Center

Carter Boyd Robert Oster Omotola Ashorobi Dustin Whitaker Kyle Wood Dean G Assimos Lisa Harvey Ross P Holmes

There is a paucity of studies addressing the accuracy of 24-hour urine collection for assessing stone risk parameters. Collection accuracy is thought to be essential for assigning optimal therapy for stone prevention. The objective of this study was to determine factors associated with accurate and inaccurate collections. During a 2-year period (2015-2016), 241 stone formers completed 24-hour urine collections. They were divided into accurate collectors (AC), defined as at least one accurate urine collection, and inaccurate collectors (IC). Accuracy was assessed by 24-hour urine creatinine (Cr) excretion indexed to body weight (normal: males, 20-25 mg Cr/kg; females, 15-20 mg Cr/kg). Demographic data analyzed included age, gender, race, insurance status, partner status, income, and education. Statistical analysis methods included the chi-square test, Fisher’s exact test, and the two-group t-test. Average age was 50.7 years at the time of collection; 50.2% were men, 86% were white, and 14% were black. Overall, 51.0% of collections were inaccurate. There was no statistical significance between AC and IC for gender (P = 0.85), race (P = 0.90), insurance status (P = 0.85), recurrence (P = 0.87), stone type (P = 0.57), education (P = 0.35), income (P = 0.42), or poverty (P = 0.35). Older age (P = 0.017) and having a partner (P = 0.022) were significantly associated with AC. The high rate of inaccurate 24-hour urine collections is a concern. The only factors we identified as influencing collection accuracy were age and partner status. These results underscore the importance of developing methods to improve the accuracy of collecting 24-hour urine samples. [Rev Urol. 2018;20(3):119–124 doi: 10.3909/riu0807] © 2018 MedReviews®, LLC

Kidney stones Metabolic evaluation 24-hour urine collection accuracy Demographics Socioeconomic factors

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