Conference Presentation

Profound Medical to present CAPTAIN safety data on TULSA vs. prostatectomy at SRS2026

The randomized trial's primary completion date has already slipped a year, and the July 26 session is billed as safety outcomes, not the efficacy result investors are waiting on.

By AppliedXLJuly 15, 2026Trial NCT05027477

Executive Summary

Profound Medical will put CAPTAIN trial data in front of surgeons for the first time at a robotic surgery conference, with the flagship session framed around safety rather than the efficacy comparison the trial was built to answer.
The trial's registered completion timeline has already passed once it was extended, and the study has gone quiet on the public registry for well over two years, raising the question of whether the conference disclosure is ahead of or behind the trial's actual progress.
CAPTAIN is a randomized, non-industry-sponsored comparison of a incisionless ablation procedure against removal surgery, the kind of head-to-head evidence that would matter to how urologists choose between options for localized prostate cancer.
The primary efficacy endpoint, freedom from treatment failure, has not been reported yet, and how it reads relative to prostatectomy is the result that will actually reset the comparison.

The presentation

Profound Medical Corp. disclosed on July 15, 2026 that physicians from UT Southwestern Medical Center will present CAPTAIN trial results at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, running July 23 through 26. The lead session, titled "CAPTAIN Randomized Controlled Trial of MRI-guided Transurethral Ultrasound Ablation (TULSA) vs. Radical Prostatectomy: Primary Safety Outcomes," runs July 24. A second session, "TULSA: Patient Selection and Outcomes (CAPTAIN Trial)," runs July 26. Both are presented by Xiaosong Meng of UT Southwestern. Profound

What the trial tests

CAPTAIN (NCT05027477) is a randomized trial enrolling 201 men with intermediate-risk, treatment-naive localized prostate cancer to compare TULSA, an MRI-guided transurethral ultrasound ablation procedure, against radical prostatectomy. The registered primary endpoint is the proportion of patients free from treatment failure, an efficacy measure, not the safety outcomes the July 24 session is billed to cover. The trial runs across 17 sites in the United States, Canada, and Finland, and is sponsored by Profound Medical Inc., not an industry-class sponsor by registry classification. NCT05027477

The timing signal

The trial's registered primary completion date moved once, from December 1, 2023 to December 9, 2024, a 374-day delay recorded on November 14, 2023. That revised date has now passed by more than seven months, and the registry record has not been modified since April 11, 2024, more than two years before this conference disclosure. The trial's listed status is Recruiting in the registry, though the linked protocol-stability tool separately shows it as Active, not recruiting, at the most recent check, an unresolved divergence in the two records rather than a single confirmed status. No results have been posted on ClinicalTrials.gov for the study to date. NCT05027477

The competitive frame

TULSA competes against the established surgical standard, radical prostatectomy, rather than against other ablation devices; no competing trial arms were found in a search of trials referencing the TULSA procedure. That leaves CAPTAIN as a comparison of a device-based, incisionless approach against an established procedure with a long track record, meaning the relevant bar is whether TULSA's oncologic control holds up against prostatectomy's established outcomes, not differentiation from a rival ablation technology.

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.