ASCENDE-RT: An Analysis of Health Related Quality of Life for A Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost to Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer

Abstract Purpose To report the patient reported health-related quality of life (HR-QoL) outcomes for a multicenter randomized trial evaluating the safety and efficacy of two different techniques for dose escalation. Materials and Methods 357 men with intermediate-and high-risk prostate cancer were stratified by risk group and randomized (1:1) to either a dose escalated external beam (DE-EBRT) boost (N =177) or a low-dose-rate prostate brachytherapy (LDR-PB) boost (N =180) as part of combined modality therapy. HR-QoL was assessed using the SF36v2TM questionnaire with additional scales for urinary, bowel and sexual function. Date of starting ADT was considered time zero, the median follow up is 6 years. Scales were scored from 0-100; a decline in a mean score ≥10 compared to baseline was considered a clinically significant decline. This is an intent-to-treat analysis. Results Mean domain scores at baseline were well balanced between two treatment arms. A clinically significant decline in mean scores in both the arms compared to baseline was noted for role physical (DE-EBRT (-11.4) and LDR-PB (-15.3)) and sexual functions scale ((DE-EBRT (-15.1) and LDR-PB (-19.2)). There was a significantly larger drop in mean scores in LDR-PB group compared to DE-EBRT group for physical function (-15.3 vs. -6.9; p=0.03), urinary function (-3.6 vs. -0.5; p=0.04). Conclusion At 6 years follow up, there were no significant differences in mean scores in nine out of eleven scales compared to baseline in both arms. A clinically significant decline in mean scores was noted in both the arms for role physical and sexual function scales. There was statistically significant decline in physical function and urinary function scale in LDR-PB arm compared to DE-EBRT arm.