The title of Profound Medical’s (NASDAQ:PROF; TSX:PRN) press release today, “Robotic Radical Prostatectomy Comes Up ‘Short’ in CAPTAIN Trial,” playfully set the tone for its reporting of a sensitive subject: penile length secondary endpoint data from the Level 1 post-market CAPTAIN randomized controlled trial comparing its TULSA Procedure with robotic radical prostatectomy (robotic RP) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.
The new penile length results in favor of the TULSA Procedure were presented for the first time by Xiaosong Meng, MD, PhD, an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, at SRS2026.
Dr. Meng’s SRS presentation highlighted:
- No median change in penile length at 1 month after whole-gland TULSA, compared with a median 0.65 cm reduction in penile length after robotic RP.
- A statistically significant between-arm difference in change in penile length estimated from a mixed-effects model (0.42 cm; p<0.001).
- Additional quality of life context following Profound’s previously announced CAPTAIN primary safety endpoint results, in which TULSA demonstrated statistically significant superiority over robotic RP in preserving both erectile function and urinary continence at 6 months.
“Penile length is not something many men feel comfortable talking about, even in the absence of prostate disease,” said Arun Menawat, Profound’s CEO and Chairman, in a statement. “Because the penis may be deeply tied to their identity, masculinity, and/or self-worth, even small amounts of penile shrinkage can cause men a lot of additional worry and distress. This new data points to the greater peace of mind that the TULSA Procedure can deliver to patients by gently, safely and precisely ablating prostate tissue while actively protecting surrounding structures.”
In March, Profound announced superiority on the prespecified, primary safety endpoint in CAPTAIN, demonstrating that the TULSA Procedure significantly improves erectile function and continence vs. robotic RP.
CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is a prospective, multi-center randomized controlled trial aimed at comparing the safety and efficacy of the TULSA Procedure (performed with the TULSA-PRO system) with robotic RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. 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. The goal of CAPTAIN is to demonstrate that the efficacy of the TULSA procedure is not inferior to robotic RP, while demonstrating superior quality of life outcomes.
By combining incisionless surgery, real-time MRI guidance, artificial intelligence, and supervised robotic autonomy, Profound’s TULSA-PRO platform enables surgeons to deliver highly personalized treatment based on each patient’s unique anatomy and disease. Physicians use the TULSA Procedure to see, ablate, and confirm therapy in real time, supporting treatment strategies across the continuum of prostate care—from whole-gland to focal ablation, and everything in between. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
