Profound Medical's CAPTAIN trial to present TULSA safety data vs prostatectomy
The randomized CAPTAIN trial presents primary safety outcomes for the TULSA ablation procedure against radical prostatectomy, four years into a trial whose completion date has already slipped a year.
Executive Summary
- A randomized trial testing an incisionless ablation procedure against the surgical standard for localized prostate cancer will disclose its first safety data at a robotic surgery conference.
- Because the comparator is radical prostatectomy itself rather than a historical cohort, the safety comparison carries a real reference point, even though it stops short of the efficacy question the trial was designed to answer.
- The trial's completion timeline already shifted once, and the underlying registry record has gone unrefreshed for an extended stretch, which matters for judging how current the safety picture being presented actually is.
- The efficacy comparison, the trial's actual primary purpose, remains the readout that will determine whether TULSA changes practice against prostatectomy.
The presentation
Xiaosong Meng of UT Southwestern Medical Center will present "CAPTAIN Randomized Controlled Trial of MRI-guided Transurethral Ultrasound Ablation (TULSA) vs. Radical Prostatectomy: Primary Safety Outcomes" at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale on July 24, 2026. The trial, registered as NCT05027477 and known by the acronym CAPTAIN, is a randomized comparison of Profound Medical's MRI-guided TULSA Procedure against radical prostatectomy in men with localized, intermediate-risk prostate cancer. The registered primary outcome measure is the proportion of patients free from treatment failure, an efficacy endpoint; Thursday's session covers safety outcomes, a distinct piece of the trial's evidence base rather than the primary result itself. Profound+1Profound Medical: Autonomous Robotics and Incisionless Surgery to Have Exceptional Presence at ...Jul 15, 2026A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate CancerNCT05027477
Why the design matters
CAPTAIN randomizes against radical prostatectomy itself, the established surgical treatment for localized prostate cancer, rather than comparing TULSA to a historical or registry cohort. That design lets a safety comparison stand against a live control arm instead of a benchmark drawn from outside literature. The trial enrolled at 17 sites across the United States, Canada, and Finland toward an anticipated 201 participants, and intervention is device-based rather than pharmacologic. Enrollment criteria restrict the study to men aged 40 to 80 with NCCN intermediate-risk disease, treatment-naive, and otherwise eligible for radical prostatectomy, which anchors the safety comparison to a population where surgery is a realistic alternative. NCT05027477A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate CancerNCT05027477
The timeline shift
The trial's primary completion date moved once, from December 1, 2023 to December 9, 2024, in an amendment logged November 14, 2023, a 374-day delay. That is the only primary-completion-date change on record, and the registry classifies the trial's amendment frequency as stable at roughly one change per year. The trial started enrolling in November 2021 and was still listed as Recruiting as of its last registry update in April 2024, with an overall study completion date extending to December 2034. NCT05027477A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate CancerNCT05027477
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.