Gregg Eure

Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000.

BACKGROUND AND PURPOSE Transurethral microwave thermotherapy (TUMT) is an effective therapy for symptomatic benign prostatic hyperplasia (BPH), but the trade-off between the magnitude of clinical improvement and side effects and patient tolerance has limited its appeal to patients and urologists. This study, using the TherMatrx TMx-2000, a TUMT device that directly heats the transition zone to greater than 50 degrees C, has been focused on resolving these issues and developing a truly office-based therapy that is well tolerated with a benign post-treatment course. PATIENTS AND METHODS This study was multi-institutional and designed as a blinded, randomized, and sham-controlled trial. A series of 200 patients with an AUA Symptom Index (AUASI) of >12, a peak flow rate of <12 mL/sec, and cystoscopic evidence of BPH were randomized 2:1 (active to sham) and treated in seven physician offices under a Food and Drug Administration-supervised and audited premarket approval protocol. No intravenous sedation was used in any patient. Follow-up for the sham-treatment group was 3 months, at which time, patients could cross over to an active treatment. A total of 119 patients have completed 1-year follow-up. RESULTS The active and sham groups were statistically identical at baseline. The 1-hour total treatment was extremely well tolerated using urethral lidocaine and oral medications; not a single prostate block or parental dose of medication was required. The active-treatment group demonstrated a statistically significant reduction (p < 0.05) in AUASI at 3 months compared with sham treatment, with an AUASI decrease from 22.4 to 12.4 (n = 124) for active v 22.9 to 17 for sham (n = 62). For the 119 patients in the active arm who have reached 12 months, the AUASI has fallen to 10.6 points (47.1% decrease), and the peak flow rate has increased 5.0 mL/sec (58.1%). Postprocedure catheterization was typically 2 or 3 days, and the 16.8% of patients who failed their first voiding trial all voided within 1 week. No major adverse events such as stricture, rectal findings, or ejaculatory changes have been reported. CONCLUSIONS This study demonstrates that the TherMatrx TMx-2000 TUMT effectively treats symptomatic BPH in the physician office with minimal morbidity.

WATER II (80-150 mL) procedural outcomes

To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia (BPH).

MP02-09 EVALUATION OF SURGICAL OUTCOMES WITH PHOTOSELECTIVE GREENLIGHT XPS LASER VAPORIZATION OF THE PROSTATE IN HIGH MEDICAL RISK MEN WITH BENIGN PROSTATIC ENLARGEMENT: A MULTICENTER STUDY

underexplored. Herein, we describe outcomes of HoLEP in a select cohort of patients with significant LUTS, and known low risk PCa. METHODS: Data were collected retrospectively on patients undergoing HoLEP by a single surgeon. A select group of well informed patients with large symptomatic glands and low risk cancer were carefully counseled that HoLEP was an option to address the obstructive BPH, would unpredictably remove the cancer (all, part, or none), emphasizing they were not undergoing a cancer operation, and that HoLEP would be followed by continued surveillance. Preand postoperative clinical factors, and operative and hospital stay data were collected. RESULTS: In total, 7 men were included. All men had Gleason 3+3 cancer in at most 20% of at most 3 cores on biopsy. Other preop characteristics are described in Table 1. Mean tissue removed was 48.8g. No patients required transfusion or reoperation. Median length of hospital stay was 24.5 hours; median length of catheterization was 19 hours. On final pathology, 3 of 7 of patients had cancer in the specimen, all of which were Gleason 3+3. At f/u, all flow rates improved, PVR improved or remained low, and PSA significantly decreased in all patients (Table 1). No patient have developed stricture, bladder neck contracture, incontinence, or required reoperation. Median f/u time was 4 months (range 4-24 months). Notably, 2 patients had prostate MRI within 2 years of HoLEP, neither of which showed suspicion for PCa. CONCLUSIONS: We have offered HoLEP judiciously to select patients on surveillance for low risk PCa and significant symptomatic BPH, a complex and increasingly common scenario, with acceptable short term outcomes. Further investigations into long-term cancerspecific outcomes, as well as strategies for continued surveillance, will be crucial in order to further evaluate and refine this new approach.

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.