Profound Medical (NASDAQ: PROF; TSX: PRN) has announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure with robotic radical prostatectomy (RP) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.
Clinical outcomes to six months post-treatment were presented earlier today by Laurence Klotz, CM, MD, FRCS, an esteemed urologist, a professor of surgery at the University of Toronto, the Sunnybrook Chair of Prostate Cancer Research, and one of the investigators for the CAPTAIN trial, during the Late-Breaking and High-Impact session at the 41st Annual European Association of Urology Congress in London, UK.
Dr. Klotz’s EAU 2026 presentation highlighted:
- CAPTAIN Trial Primary Safety Endpoint (Functional Outcomes) Met: The TULSA Procedure has proven statistical superiority over RP on the prespecified, primary composite safety endpoint, with 50% of patients preserving both erectile function and urinary continence at 6 months after TULSA vs. 24% after RP (p<0.05, risk ratio 2.1).
- Favourable Quality-of-Life Outcomes: Urinary continence, the most important quality of life outcome for patients after prostate cancer treatment, was superior after the TULSA Procedure compared to RP. TULSA preserved pad-free continence in 84% of men at 6 months, compared to only 49% after RP. Patient-reported erectile function was also preserved in more men at 6 months after TULSA (56%) compared to RP (47%). These functional outcomes after TULSA are similar to those measured in the single-arm TACT pivotal FDA registration study, which reported preservation of urinary continence and erectile function at 6 months in 86% and 59% of men, respectively. Notably, the RP outcomes reflect those by high volume robotic surgeons with extensive experience and the use of nerve sparing techniques in 95% of cases. Despite these optimized surgical conditions, favorable quality of life outcomes after TULSA were demonstrated head-to-head to RP.
- Improvement in Perioperative Measures: Within the 30-day perioperative period, there was zero blood loss after TULSA 0 (IQR 0-0) mL vs. RP 150 (100-200) mL, p<0.001; no overnight stay 0.3 (0.2-0.3) days TULSA vs. RP 1.1 (1.1-1.3 days); p<0.001; reduced pain in the first week, and significantly better preservation (or improvement) of patient-reported overall health (EQ-5D-5L). Patients missed significantly less time from paid employment after TULSA 10 (4 – 15) days vs. RP 19 (10 – 41) days, p<0.05.
- Lower Rate of Serious Complications: Within 90 days, significantly fewer patents incurred a complication requiring hospitalization after TULSA (0.7%) vs. RP (6.3%), p<0.05. No patient required ICU admission after TULSA, vs. 1.6% after RP.
- Secondary Oncologic Outcomes Pending: Secondary oncologic outcomes include histology, and are currently available for the RP arm by 6 months only. On surgical pathology, 33% of RP patients had a positive surgical margin and 35% were upstaged. These findings are consistent with the surgical approach used in this cohort, in which high volume surgeons employed nerve sparing techniques in 95% of patients, prioritizing functional preservation. TULSA Procedure histology and imaging await 12-month biopsy and MRI, which the Company expects to be in a position to report later this year.
In a statement, Dr. Klotz commented, “CAPTAIN is a first-of-its-kind study, successfully recruiting patients into a head-to-head comparison of the TULSA Procedure and robotic RP for both safety and oncologic control. The study tests whether the TULSA Procedure is superior to RP for functional outcomes and not inferior to RP for oncologic control. Establishing these outcomes would facilitate moving the TULSA Procedure into the standard of care. We have reached a foundational milestone by proving superior safety. At 6 months, patients treated with TULSA-PRO were more than twice as likely to preserve both pad-free continence and erections sufficient for intercourse compared to surgery, delivering functional outcomes that track the established body of evidence for the TULSA Procedure. The TULSA Procedure also proved a less invasive experience marked by zero blood loss and no overnight stay, faster recovery to baseline, day-to-day activities and return to work, and significantly fewer, serious complications. Secondary oncologic endpoints available later this year for the TULSA Procedure arm will serve as a window into the 3-year primary oncologic endpoint.”
Arun Menawat, CEO and chairman, of Profound, remarked, “CAPTAIN is a Level 1 study designed to provide the first true apples-to-apples comparison of the safety, quality of life and oncological control of two prostate cancer treatment modalities. Randomized 2:1 using an intelligent stratification algorithm, resulting in highly balanced trial arms, CAPTAIN now positions us to demonstrate with statistical rigor the TULSA Procedure’s superior quality of life profile while delivering the whole-gland treatment efficacy of robotic RP. We look forward to announcing additional clinical outcomes from this unique, potentially paradigm-changing study when they become available later this year.”
CAPTAIN exceeded its enrollment target, treating 211 patients, instead of the initially planned 201 patients, by August 2025 at 20 sites in the United States, two in Canada and one in Europe. Baseline patient characteristics are balanced for the TULSA Procedure vs. robotic RP (all p>0.05): median (IQR) age 63 (58-68) vs. 65 (60-69) years, PSA 6.5 (4.9-9.6) vs. 7.2 (5.6-9.7) ng/mL, prostate volume 41 (31-50) vs. 35 (29-47) cc, proportions of TULSA vs. RP patients with Grade Group 2/3 disease were 76%/24% vs. 77%/23%, and proportions with (IIEF Q2) erectile function and (EPIC) pad-free continence 84% vs. 76%.
Webinar Details
Profound Medical is pleased to invite all interested parties to view a recording of its investor webinar held on Friday, March 13, during which Dr. Klotz reviewed the CAPTAIN data and its clinical relevance, and Profound management discussed the commercial implications of the data and next steps in advancing the TULSA Procedure toward potential inclusion in prostate cancer treatment guidelines.
A recording of the webinar is available here.
