Bela Denes

In vitro comparison of shock wave lithotripsy machines

PURPOSE We tested the hypothesis that shock wave lithotripsy machines vary in the ability to fragment stones to small size. MATERIALS AND METHODS Calcium oxalate monohydrate, calcium hydrogen phosphate dihydrate, cystine and magnesium ammonium phosphate hexahydrate calculi were fragmented in vitro with the 22 kV. Dornier HM3, section sign 20 kV. Storz Modulith SLX, parallel, 15.6 kV. Siemens Lithostar C, paragraph sign 24 kV. Medstone STS-T,** 26 kV. HealthTronics LithoTron 160,daggerdagger 20 kV. Dornier Doli section sign and 22.5 kV. Medispec Econolithdouble daggerdouble dagger lithotriptors. Stones were given 500 or 2,000 shocks, or the Food and Drug Administration limit. Post-lithotripsy fragment size was characterized using sequential sieves and compared. RESULTS Stone mass was statistically similar in the cohorts (p >0.94). Fragment size decreased as the number of shocks increased when the machine and stone composition were constant. Magnesium ammonium phosphate hexahydrate calculi were completely fragmented by all devices. At Food and Drug Administration treatment limits the mean incidence per device of calcium hydrogen phosphate dihydrate, calcium oxalate monohydrate, cystine and magnesium ammonium phosphate hexahydrate stones rendered into fragments greater than 2 mm. was 0% for the HM3, Modulith SLX and Lithostar C, 10% for the STS-T, 3% for the LithoTron 160, 29% for the Doli and 18% for the Econolith (p = 0. 04); 0% for the HM3, Modulith SLX, Lithostar C, STS-T and LithoTron 160, 4% for the Doli and 9% for the Econolith (p = 0.15); 1% for the HM3, 0% for the Modulith SLX, 1% for the Lithostar C, 10% for the STS-T, 14% for the LithoTron 160, 3% for the Doli and 9% for the Econolith (p = 0.44); and 1% for the HM3, 0% for the Modulith SLX, 1% for the Lithostar C, 10% for the STS-T, 14% for the LithoTron 160, 3% for the Doli and 9% for the Econolith (p = 0.44), respectively. CONCLUSIONS Shock wave lithotriptors vary in fragmentation ability. The HM3, Modulith SLX and Lithostar C machines yield smaller fragments than other machines.

Factors Influencing Prostate‐Specific Antigen Response among Men Treated with Testosterone Therapy for 6 Months

INTRODUCTION Factors influencing prostate-specific antigen (PSA) changes in men undergoing testosterone (T) therapy have not been well studied. AIM The aim of this study was to assess the influence of selected variables on PSA changes in hypogonadal men administered with 1.62% testosterone gel (T-gel) for 6 months. METHODS A double-blind, placebo-controlled study of 274 (234 T-gel, 40 placebo) hypogonadal men >18 years of age, with baseline T concentrations <300 ng/dL, PSA ≤2.5 ng/mL, and negative digital rectal examination. Subjects received once-daily T-gel for T therapy. MAIN OUTCOME MEASURES Changes in mean serum PSA, percentage of free PSA (%fPSA), and T from baseline to 6 months (182 days). RESULTS Mean age was 53.5 years and baseline mean values were total T 247 ng/dL, PSA 0.9 ng/mL, and %fPSA 24.6%. Among men treated with T-gel, T increased to 499 ng/dL and PSA increased by 0.1 ng/mL (P = 0.0012). PSA increased ≥0.3 ng/mL in 26.3%, <0.3 ng/mL in 73.7%, including a decline from baseline in 33.0%. In the placebo group, T increased 29 ng/dL to 274 ng/dL, and PSA decreased 0.1 ng/mL, compared with baseline. A greater increase in PSA was noted in men ≥60 years old than in men <60 years old (0.4 vs. 0.05 ng/mL, respectively; P = 0.0006). Mean PSA did not change in men with baseline serum T >250 ng/dL, whereas it increased by 0.2 ng/mL in men with T ≤250 ng/dL (P = 0.0031). PSA increased 0.3 ng/mL in men with baseline %fPSA <20% and 0.1 ng/mL in men with %fPSA ≥20%. CONCLUSIONS Overall, T-gel treatment was associated with a minor increase in PSA, of questionable clinical significance. Factors predicting greater PSA increases included age ≥60 years, baseline T ≤250 ng/dL, and %fPSA <20%. Men with T >250 ng/dL and age <60 years demonstrated minimal or no PSA change.

The Impact of a Biopsy Based 17-Gene Genomic Prostate Score on Treatment Recommendations in Men with Newly Diagnosed Clinically Prostate Cancer Who are Candidates for Active Surveillance

Introduction: The biopsy based 17‐gene GPS was clinically validated to predict the likelihood of adverse surgical pathology in men with NCCN® very low, low or low‐intermediate risk prostate cancer. We performed a prospective study to assess the impact of incorporating GPS into treatment recommendations in 3 high volume urology practices. Methods: Men with newly diagnosed prostate cancer meeting specific NCCN criteria were prospectively enrolled in the trial. Biopsy tissue was analyzed. Urologists indicated treatment recommendations on questionnaires administered before and after GPS. The primary study objectives were to assess all changes in treatment modality and/or treatment intensity after GPS. Results: A total of 158 men were included in analysis, including 35, 71 and 52 at NCCN very low, low and low‐intermediate risk. Biological risk predicted by GPS differed from NCCN clinical risk alone in 61 men (39%). Overall 18% of recommendations between active surveillance and immediate treatment changed after GPS. The relative increase in recommendations for active surveillance was 24% (absolute change 41% to 51%). In 41 of 158 men (26%) modality and/or intensity recommendations changed after GPS, including 25, 14 and 2 in whom recommendation intensity decreased, increased and were equivocal, respectively. All changes were directionally consistent with GPS. The NCCN low risk group showed the greatest absolute recommendation change after GPS (37%). In 17 of 57 men (30%) the initial recommendation of radical prostatectomy was changed to active surveillance after GPS. Urologists indicated greater confidence and found that incorporating GPS was useful in 85% and 79% of cases, respectively, including when biological risk confirmed the clinical risk category. Conclusions: This study demonstrates that the 17‐gene GPS influenced treatment recommendations among urologists and provided increased confidence in these recommendations in patients at NCCN very low to low‐intermediate risk.

Use of a 17-Gene Prognostic Assay in Contemporary Urologic Practice: Results of an Interim Analysis in an Observational Cohort

OBJECTIVE To study the impact of genomic testing in shared decision making for men with clinically low-risk prostate cancer (PCa). MATERIALS AND METHODS Patients with clinically low-risk PCa were enrolled in a prospective, multi-institutional study of a validated 17-gene tissue-based reverse transcription polymerase chain reaction assay (Genomic Prostate Score [GPS]). In this paper we report on outcomes in the first 297 patients enrolled in the study with valid 17-gene assay results and decision-change data. The primary end points were shared decision on initial management and persistence on active surveillance (AS) at 1 year post diagnosis. AS utilization and persistence were compared with similar end points in a group of patients who did not have genomic testing (baseline cohort). Secondary end points included perceived utility of the assay and patient decisional conflict before and after testing. RESULTS One-year results were available on 258 patients. Shift between initial recommendation and shared decision occurred in 23% of patients. Utilization of AS was higher in the GPS-tested cohort than in the untested baseline cohort (62% vs 40%). The proportion of men who selected and persisted on AS at 1 year was 55% and 34% in the GPS and baseline cohorts, respectively. Physicians reported that GPS was useful in 90% of cases. Mean decisional conflict scores declined in patients after GPS testing. CONCLUSION Patients who received GPS testing were more likely to select and persist on AS for initial management compared with a matched baseline group. These data indicate that GPS help guide shared decisions in clinically low-risk PCa.

Utility of the Oncotype DX® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis

Introduction: The 17‐gene Oncotype DX® prostate cancer assay (Genomic Health Inc., Redwood City, California) is a validated, biopsy based gene expression assay that reports the Genomic Prostate Score. Combined with clinical risk features, Genomic Prostate Score provides an individualized estimation of disease aggressiveness at diagnosis. With this retrospective chart review we assessed the impact of incorporating the Oncotype DX Genomic Prostate Score on treatment recommendations and decisions for men with newly diagnosed low risk prostate cancer in community urology practices. Methods: A total of 24 urologists who ordered the Oncotype DX prostate cancer assay soon after launch (May 2013) were invited to participate in the study. Clinicopathological data, Genomic Prostate Score results and treatment related information were retrieved from medical records. Data also were collected for a pre‐Genomic Prostate Score baseline group diagnosed from May 2012 to April 2013. Descriptive analyses were performed to evaluate the proportion of men for whom active surveillance was recommended and used before and after the availability of Genomic Prostate Score. Results: Overall 15 physicians contributing 211 patients (Genomic Prostate Score group 124, baseline group 87) participated in the chart review. Patients in the Genomic Prostate Score and baseline groups had comparable risk based on traditional clinical pathological features, with 82% with NCCN® very low or low risk disease. With Genomic Prostate Score the relative increase in active surveillance recommended was 22% (baseline 50% and Genomic Prostate Score 61%, absolute increase of 11%) and the relative increase in use of active surveillance was 56% (baseline 43% and Genomic Prostate Score 67%, absolute increase of 24%). Treatment recommendations for active surveillance were directionally consistent with assay reported risk. Conclusions: Genomic Prostate Score testing was associated with greater physician recommendation of and use of active surveillance in community clinical practices.

Mesothelial Inclusions in Pelvic Lymph Nodes Initially Diagnosed as Metastatic Prostate Cancer; the Utility of Second Opinions and Genomic Testing in the Setting of Unexpected Results

Benign mesothelial inclusions in pelvic lymph nodes may be mistaken for metastatic disease in the setting of pelvic malignancy. In this case-report a patient with Low-Risk prostate cancer (confirmed by biopsy and genomic testing) underwent radical prostatectomy with pelvic lymph node dissection. The initial pathological diagnosis was organ-confined Gleason 3 + 3 = 6 cancer with metastasis to a pelvic lymph node. Upon review of the pathological specimen and immunohistochemical staining the lymph node tissue concerning for metastatic disease was recharacterized as mesothelial in origin. This case illustrates the importance of second opinions and immunohistochemistry for unexpected or unusual pathological findings.

MP86-16 A MULTI-CENTER ANALYSIS OF PROSTATE CANCER (PCA) TREATMENT AMONG VETERANS FOLLOWING INTRODUCTION OF THE 17-GENE GENOMIC PROSTATE SCORE (GPS) ASSAY

RESULTS: 627 men were eligible for the study. Age, ethnicity, primary language, education and Charlson comorbidity did not differ across PSA strata. Compared to the referent group PSA <10, those with PSA 50 were more likely to receive androgen deprivation therapy as their primary form of treatment (p <0.01). Patients with PSAs 10-19.9 were more likely to have sexual bother (b1⁄411.1, p<0.03) compared to the referent group. (See Table) There were no other differences in other HRQOL domains across PSA strata. CONCLUSIONS: In this population, we found no statistically significant difference in HRQOL outcomes by PSA level. The finding that patients with very elevated PSA levels having outcomes that were no worse than patients with less aggressive disease is important clinically because most quality of life detriments tend to be from treatment of localized disease. Further, these findings will inform physicians on patient symptomatology despite PSA level.

MP28-11 IMPACT OF THE 17-GENE PANEL ON ACTIVE SURVEILLANCE PERSISTENCE IN CONTEMPORARY UROLOGIC PRACTICES: AN INTERIM ANALYSIS IN AN OBSERVATIONAL COHORT

INTRODUCTION AND OBJECTIVES: The 17 gene assay (Oncotype Dx Genomic Prostate Score, GPS) is a validated, biopsybased commercial gene expression assay that, combined with clinical features, provides an individual estimate of disease aggressiveness at the time of PCa diagnosis. We report interim study results on the impact of GPS on the management of clinically low risk PCa patients in community-based urology practices. METHODS: 1,200 patients were prospectively enrolled from 26 sites. For this interim analysis, we report 1 year outcomes in the first 297 patients with valid GPS results. The primary endpoints were GPS’ impact on initial management and persistence on active surveillance (AS) at 1 year post-diagnosis in patients who chose to pursue AS. Rates of AS utilization and persistence in GPS tested patients were compared with a group of 247 patients who did not have genomic testing managed in the same practices (baseline cohort). Descriptive statistics were reported. Analyses were conducted using SAS 9.4. RESULTS: One-year results were available in 258/297 tested patients (26% NCCN VL, 43% Low and 31% Intermediate). Both utilization and persistence on AS were higher in the GPS-tested cohort (62% vs 40% AS adoption and 89% vs 86% AS persistence) at 1 year. Higher utilization and persistence on AS resulted in a 21% absolute increase in the proportion of men on AS at 1 year postdiagnosis in the GPS tested cohort compared to and baseline (Figure 1). Net increases of patients on AS at 1 year were seen across age groups (59% vs. 41% in >1⁄465yrs, and 51% vs. 29% in <65 yrs), and racial groups (51% vs. 39% in African American, and 55% vs. 33% in all other racial groups). CONCLUSIONS: Patients, especially younger men, and physicians who received GPS were more likely to pursue AS for initial management than untested patients. Overall utilization of AS was 62% higher in GPS tested vs. untested patients at 1 year post-diagnosis. The individual risk refinement provided by genomic testing demonstrates the impact of the GPS in identifying appropriate patients and supporting more AS decisions in clinically low risk PCa.

Association of PSA and number of cores positive with likelihood of adverse pathology at radical prostatectomy based on a 17-gene expression assay.

e16570Background: The overtreatment of prostate cancer and underutilization of active surveillance in men with Gleason 6 (GS6) cancer stems from uncertainty with current risk instruments such as vo...