1002 - EPIC-26 Longitudinal Analyses of Prostatic Urethral Lift Implant with Stereotactic Ablative Body Radiotherapy for Men with Prostate Cancer and Benign Prostatic Hyperplasia

Purpose/Objective(s): The optimal use of outlet procedures in SAbR is unknown and is dependent on patient-perception. In our institutional phase I trial, we sought to evaluate the safety and feasibility of performing Prostatic Urethral Lift (PUL), followed by SAbR for men with baseline lower urinary symptoms related to benign prostatic hyperplasia (BPH). Understanding the importance of quality-of-life (QoL) metrics, we obtained patient- reported QoL measures using validated questionnaires as secondary endpoints.

Materials/Methods: Our phase I, non-blinded single-arm safety trial enrolled 15 patients, meeting our target accrual goal. Men with prostate volume > 100 g, prior prostate surgery, prior androgen deprivation therapy, or those whose PSA > 20 ng/ml were excluded. PUL, rectoprostatic spacer gel and fiducial markers were implanted simultaneously under general anesthesia. Our study participants underwent SAbR to a total dose of 4000 cGy in 5 fractions to the prostate and the proximal seminal vesicles. QoL parameters included the American Urologic Association (AUA) symptom score and four domains of the Prostate Cancer Index-Short Form (EPIC-26). Four EPIC-26 subscales in incontinence, irritation/obstruction, bowel and sexual domains were analyzed at five time points longitudinally: 1) baseline, 2) early post-PUL, 3) 5-week post-PUL, 4) early post-SAbR, and 5) 3-month post-SAbR.

Results: The mean prostate volume was 49.9 cc (range 19-70). While the changes in the AUA symptom scores at baseline and 3-month post-SAbR were statistically different (22.1 vs. 15.2; p<0.01 Wilcoxon Rank Sum), the changes in the EPIC urinary obstructive/irritative scores were not statistically significant (64.6 vs. 80.6; p=0.08). Otherwise, participants had stable symptoms in urinary incontinence, bowel, and sexual domains.

Conclusion: We observed a modest improvement of obstructive urinary symptoms at 3-month post-SAbR visit based on the change in AUA symptom scores. There was a trend towards statistical significance for the changes in the EPIC urinary obstructive/irritative scores. A longer-term follow-up visits are required to better understand urinary, bowel, and sexual outcomes after the combined procedures of PUL and SAbR.