CAPTAIN Trial Comparing Profound's MRI-Guided TULSA Procedure™ to Robotic Radical Prostatectomy Successfully Meets Primary Safety Endpoint, Preservation of Erectile Function and Urinary Continence

Core Insights - Profound Medical Corp. announced the superiority of the TULSA Procedure over robotic radical prostatectomy (RP) in terms of primary safety endpoints in the CAPTAIN trial for men with intermediate-risk prostate cancer [1][5] Group 1: CAPTAIN Trial Overview - The CAPTAIN trial exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aimed to compare the safety and efficacy of the TULSA Procedure with RP, focusing on preserving erectile function and urinary continence [8] Group 2: Clinical Outcomes - At 6 months post-treatment, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, indicating a statistically significant improvement (p<0.05, risk ratio 2.1) [5] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [5] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [5] Group 3: Perioperative Measures - TULSA demonstrated zero blood loss during the procedure, while RP had an average blood loss of 150 mL (p<0.001) [5] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP (p<0.05) [5] - There were significantly fewer serious complications requiring hospitalization after TULSA (0.7%) compared to RP (6.3%) within 90 days (p<0.05) [5] Group 4: Future Implications - The CAPTAIN trial is positioned to potentially establish the TULSA Procedure as a standard of care for prostate cancer treatment, with secondary oncologic outcomes expected later this year [6][8] - The trial's design allows for a rigorous comparison of safety, quality of life, and oncological control between the two treatment modalities [6]