The TULSA Procedure, an MRI-guided, incision-free treatment for localized prostate cancer, demonstrated statistically significant superiority over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence, according to results presented today at the European Association of Urology (EAU) 2026 Congress in London.
The Level 1 post-market CAPTAIN randomized controlled trial, conducted across 23 sites in the United States, Canada, and Europe, enrolled 211 patients – exceeding its initial target of 201 – and focused on men with organ-confined, intermediate-risk, Gleason Score 7 prostate cancer. The trial, sponsored by Profound Medical Corp., assessed outcomes at six months post-treatment.
Data presented by Laurence Klotz, CM, MD, FRCSC, of the University of Toronto, revealed that 50% of patients treated with the TULSA Procedure preserved both erectile function and urinary continence, compared to 24% of patients who underwent robotic RP (p<0.05, risk ratio 2.1). Urinary continence was preserved in 84% of TULSA patients versus 49% of RP patients, while erectile function was preserved in 56% versus 47%, respectively.
The TULSA Procedure also exhibited improvements in perioperative measures. Patients undergoing TULSA experienced zero blood loss, shorter hospital stays, reduced pain, and a faster return to work. Complications requiring hospitalization were significantly lower after TULSA (0.7%) compared to RP (6.3%) (p<0.05).
“The CAPTAIN trial positions Profound to demonstrate the TULSA Procedure’s superior quality of life profile while delivering comparable efficacy to robotic RP,” stated Arun Menawat, CEO and Chairman of Profound Medical, in a press statement. Profound Medical is hosting an investor webinar today, March 14, 2026, at 11:30 a.m. EDT to discuss the CAPTAIN data.
Baseline patient characteristics were balanced between the two treatment groups: median age was 63 years for TULSA patients and 65 years for RP patients; median PSA levels were 6.5 ng/mL, and 7.2 ng/mL, respectively; and median prostate volume was 41 cc for TULSA and 35 cc for RP. The proportion of patients with Grade Group 2/3 disease was also similar, at 76%/24% for TULSA and 77%/23% for RP. Prior to treatment, 84% of TULSA patients and 76% of RP patients reported adequate erectile function and pad-free continence.
Secondary oncologic outcomes from the CAPTAIN trial are expected later this year.
