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 - The CAPTAIN trial demonstrates that the TULSA Procedure shows significant improvement over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence at 6 months post-treatment [1][3][5] Group 1: Trial Overview - CAPTAIN trial successfully 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 aims to compare the safety and efficacy of the TULSA Procedure with RP in men with localized, intermediate-risk prostate cancer [7] Group 2: Clinical Outcomes - At 6 months, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, with a statistically significant p-value of <0.05 [3] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [3] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [3] Group 3: Perioperative Measures - TULSA showed zero blood loss compared to 150 mL after RP, with a significant p-value of <0.001 [3] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP [3] Group 4: Complications and Safety - The rate of serious complications within 90 days was significantly lower for TULSA at 0.7% compared to 6.3% for RP [3] - No patients required ICU admission after TULSA, while 1.6% did after RP [3] Group 5: Future Outlook - Secondary oncologic outcomes from the TULSA Procedure are expected to be reported later this year, which will provide further insights into its efficacy [4][5] - The trial positions the TULSA Procedure as a potential standard of care in prostate cancer treatment, pending further results [5][6]