Profound Medical Touts Positive Trial Results for MRI-Guided TULSA Procedure

Profound Medical Corp.’s MRI-guided TULSA Procedure met its primary safety endpoint—the preservation of erectile function and urinary continence, the company announced.

The endpoint was met during the Level 1 post-market CAPTAIN 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.

The randomized controlled CAPTAIN trial exceeded its enrollment target—treating 211 patients rather than 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%.

“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,” Profound Medical Chairman/CEO Arun Menawat said. “Randomized two-to-one 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 study when they become available later this year.”

Highlights of clinical outcomes to six months post-treatment:

• CAPTAIN Trial primary safety endpoint (functional outcomes) met: The TULSA Procedure has proven statistical superiority over RP on the pre-specified, primary composite safety endpoint, with 50% of patients preserving both erectile function and urinary continence at six 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 six months, compared to 49% after RP. Patient-reported erectile function was also preserved in more men at six 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 six 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 no 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 (four to 15) days vs. RP 19 (10 to 41) days, p<0.05.
• Lower rate of serious complications: Within 90 days, significantly fewer patients 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 six 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 report later this year.

“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,” stated Laurence Klotz, M.D., a urologist, professor of surgery at the University of Toronto, the Sunnybrook chair of Prostate Cancer Research, and a CAPTAIN trial investigator. “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 six 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 three-year primary oncologic endpoint.”

CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is a trial comparing the safety and efficacy of the TULSA procedure (performed with the TULSA-PRO system) with RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. CAPTAIN’s goal is to demonstrate the efficacy of the TULSA procedure is not inferior to RP, while demonstrating superior quality of life outcomes. The primary safety endpoint is the proportion of patients who preserve both erectile potency and urinary continence at one year after treatment. The primary efficacy endpoint is the proportion of patients who are free from any additional treatment for prostate cancer, free of metastases, or prostate cancer-related death by three years after treatment. Secondary endpoints include comparison of rates of complications, cost effectiveness, as well as histologic and biochemical failure.

Profound Medical is a commercial-stage medical device company and an innovator in interventional MRI procedures, enabling precise, incision-free therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MRI guidance, Profound’s technologies are designed to replace uncertainty with clarity across treatment planning, delivery, and confirmation.

The company’s flagship platform, TULSA-PRO, enables MRI-guided, incision-free prostate therapy designed for precision and flexibility. The TULSA Procedure allows physicians to see, treat, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care for the full spectrum of prostate disease, including prostate cancer and/or benign prostatic hyperplasia (BPH), while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound also commercializes Sonalleve, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery—and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared or approved in the United States, Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE, while Sonalleve is cleared or approved in the United States (HDE), Europe, Canada, China, and Saudi Arabia.