Robotic Radical Prostatectomy Comes Up ‘Short' in CAPTAIN Trial

At 1 month following the TULSA Procedure, there was no median change in penile length, compared with a median 0.65 cm reduction in penile length after robotic RP. The new penile length results in favor of the TULSA Procedure were presented for the first time earlier today by Xiaosong Meng, MD, PhD, an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, at the Society of Robotic Surgery (“SRS”) Annual Meeting held in Fort Lauderdale, FL. 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. “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.” 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. 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 is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO ®, enables MRI-guided, incision-free prostate ablation. Ph...