Toronto – October 12, 2026 -- Men treated with whole-gland TULSA Procedure showed no median change in penile length at one month, compared with a median 0.65 cm reduction after robotic radical prostatectomy (RP), according to new data from the Level 1 CAPTAIN randomized controlled trial, Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) announced.
Mixed-effects model shows 0.42 cm between-arm difference
The between-arm difference in change in penile length, estimated from a mixed-effects model, was 0.42 cm (p<0.001), which Profound describes as statistically significant. Xiaosong Meng, MD, PhD, Assistant Professor in the Department of Urology at UT Southwestern Medical Center, presented the results at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, Florida.
The data add quality-of-life context to Profound's previously announced CAPTAIN primary safety endpoint results. In those results, TULSA showed statistically significant superiority over robotic RP in preserving both erectile function and urinary continence at 6 months.
Profound CEO links penile length data to patient distress
Arun Menawat, Profound's CEO and Chairman, said even small amounts of penile shrinkage can cause men considerable worry and distress, and that the data point to greater peace of mind with TULSA.
CAPTAIN enrolled 211 patients across 23 sites
CAPTAIN is a prospective, multi-center trial comparing the TULSA Procedure, performed with the TULSA-PRO system, against robotic RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. By August 2025, the trial had treated 211 patients, against an initial plan of 201. Enrollment spanned 20 sites in the United States, two in Canada and one in Europe.
The primary safety endpoint is the proportion of patients preserving both erectile potency and urinary continence one year after treatment. The primary efficacy endpoint is the proportion of patients free from additional prostate cancer treatment, metastases or prostate cancer-related death three years after treatment. Secondary endpoints include complication rates, cost effectiveness, and histologic and biochemical failure.
The trial's stated goal is to show that TULSA efficacy is not inferior to robotic RP while delivering superior quality-of-life outcomes.