The Society of Interventional Radiology (SIR) has highlighted the results of Profound Medical’s (NASDAQ: PROF; TSX: PRN) randomized post-market CAPTAIN trial demonstrating that men with localized, intermediate-risk prostate cancer recovered faster and experienced less short-term impact on their daily lives when treated with MRI-guided, transurethral ultrasound ablation (TULSA) compared with robotic prostatectomy (RP). The results were presented at the SIR 2026 Annual Scientific Meeting in Toronto on Sunday.
SIR review spotlights randomized CAPTAIN trial data
The study followed 212 men treated at 23 medical centers between 2022 and 2025. Participants with localized, intermediate-risk prostate cancer were randomly assigned to receive either TULSA, a new, minimally invasive therapy, or RP, the long-time standard surgical approach.
The study showed that men treated with TULSA had less blood loss during the procedure, typically went home the same day, and reported less pain and faster return to normal activities one month after treatment. RP had higher rates of blood loss, were more likely to stay overnight in the hospital and reported slower recovery.
David A. Woodrum, MD, PhD, FSIR, interventional radiologist at Mayo Clinic in Rochester, and the CAPTAIN study primary investigator, commented, “For many patients, how quickly they can get back to work, family life and everyday routines really matters. These early results suggest that TULSA may allow patients to recover more quickly and maintain a better quality of life following treatment, while still effectively treating the cancer.”
Although surgical removal of the prostate, the current standard of care, is effective in terms of controlling the cancer, it may leave men with significant long-term effects such as erectile dysfunction and loss of bladder control. TULSA, however, uses real-time MRI to guide the delivery of high-energy ultrasound through the urethra and into the prostate to gently and precisely heat (55–57°C) and kill the targeted prostate tissue without damaging the surrounding nerves and anatomy. This helps to preserve urinary and sexual function, the researchers say.
Dr. Woodrum added, “While longer term cancer control and functional outcomes remain critical, early recovery is an important part of the treatment decision for patients. CAPTAIN is providing high quality randomized data to help patients and physicians have more informed conversations about treatment options.”
Recently, Profound also announced statistical superiority on the prespecified, primary composite safety endpoint in the CAPTAIN trial, 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).
In addition, 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 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 Profound says it expects to be in a position to report later this year.
