Profound Medical announces initial perioperative data from CAPTAIN trial

Profound Medical (PROF) announced initial perioperative data from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy in men with organ-confined, intermediate-risk, Gleason Score 7 prostate cancer. The perioperative results were presented yesterday by Xiaosong Meng, M.D., Ph.D., an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, at the American Urological Association Annual Meeting. Starting in 2022, CAPTAIN patients were recruited at 20 sites in the United States, two in Canada and one in Europe. As of January 2025, 201 patients were randomized and, to-date, 194 have been treated or scheduled for treatment. Baseline patient characteristics are balanced for TULSA vs RP, with median age 63 vs. 64 years, proportions with PSA less than or equal to10ng/mL 77% vs. 74%, and 23% vs 26% with PSAgreater than10ng/mL. Proportions of TULSA vs. RP patients with GG2/3 disease were 76%/24% vs. 74%/26%. All patients were EPIC pad-free at baseline. Dr. Meng’s AUA presentation highlighted that TULSA provided statistically significant improvement in all assessed perioperative measures: Blood loss: TULSA median 0 mL vs. RP 100 mL, pless than0.001. Length of stay: TULSA median 0.29 days vs. RP 1.24 days, pless than0.001. NRS pain: Significantly lower post-operative pain after TULSA procedure vs. RP through to post-treatment day 6, pless than0.05. Patient-reported health-related QOL: Significantly higher overall health on the EQ-5D-5L 0-100 VAS after TULSA vs. RP for all 30 days measured after treatment, pless than0.05. During the first month post-treatment, significantly fewer TULSA patients reported experiencing extreme problems or inability with mobility, self-care, and usual activities. Dr. Meng commented, “I commend the Sponsor and the Study Investigators for taking on this audacious study, as CAPTAIN is the fist randomized controlled trial comparing a new technology to the standard of robotic radical prostatectomy to successfully recruit to target enrollment. In addition to including some of the most talented and high volume surgeons from academic hospitals and private practice, I believe successful randomization was in large part due to TULSA’s proven safety and efficacy for whole-gland ablation in intermediate-risk prostate cancer patients, which fostered equipoise between both arms. While TULSA already has a well-established body of clinical evidence, it now has hard data that shows quantitatively in a head-to-head fashion significantly superior post-treatment patient experience compared to robotic prostatectomy.”