Profound's CAPTAIN trial heads toward a 2026 readout on TULSA vs. surgery
Profound Medical says results from its head-to-head prostate cancer trial against radical prostatectomy will publish in 2026, even as the trial's own registry record shows it still recruiting past its 2024 completion target.
Executive Summary
- Profound Medical is pointing to a head-to-head prostate cancer trial against the surgical standard of care as the evidence it will use to seek insurance coverage, but the trial's own registry status lags the publication timeline the company is citing.
- A positive readout would give the company a comparative dataset against an established surgical alternative, which it says it will use to unlock broader reimbursement and hospital adoption in Canada.
- The trial is still listed as recruiting, with a primary completion date that has already lapsed, which raises the operational question of whether a 2026 publication is achievable on the sponsor's own registry timeline.
- No competing trial in the indication directly compares a focal ablation device against radical prostatectomy, leaving this readout without a same-design precedent to benchmark against.
The announcement
Profound Medical Corp. disclosed the 2026 publication timeline for CAPTAIN inside a press release about an unrelated commercial matter: the company regaining exclusive Canadian distribution rights for TULSA-PRO from Knight Therapeutics Inc.. Arun Menawat, Profound's CEO and Chairman, said that as CAPTAIN results "are published in 2026 and beyond, we plan to use them to support our applications to the appropriate Canadian Provincial Health Insurance authorities for coverage". He added that Toronto's Sunnybrook Health Sciences Centre, which originated the TULSA-PRO technology, has already performed more than 100 TULSA Procedures. ProfoundProfound Medical Regains Exclusive Distribution Rights for TULSA-PRO® in Canada from KnightNov 10, 2025
What the trial tests
CAPTAIN (NCT05027477) is an interventional study comparing TULSA, an MRI-guided ultrasound ablation procedure, against robotic radical prostatectomy in men with intermediate-risk localized prostate cancer. The registered primary outcome measure is the proportion of patients free from treatment failure, a defined efficacy endpoint against a surgical comparator. Enrollment target is 201 patients across sites in the United States, Canada, and Finland. No results have posted to ClinicalTrials.gov for this trial to date. NCT05027477A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate CancerNCT05027477
Timing and trial status
The trial's registry status is Recruiting, and its primary completion date is listed as 2024-12-09, a date that has already passed. The trial's overall estimated completion date is 2034-12-09, a decade beyond the primary completion date, reflecting a long-term follow-up design. The gap between a lapsed primary completion date and a still-open recruiting status is the central operational fact set against Profound's 2026 publication guidance, and it means the sponsor's public timeline for CAPTAIN currently runs ahead of what the trial's own registry status shows. NCT05027477A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate CancerNCT05027477
The competitive frame
A scan of trials in the indication surfaced no comparator study directly testing a focal ablation device against radical prostatectomy for localized prostate cancer. Other prostate cancer trials referenced in the broader indication search involve different modalities and settings, including radiopharmaceutical and targeted-radiotherapy programs in metastatic castration-resistant disease, which are not direct comparators to a head-to-head localized-disease surgical trial. That leaves CAPTAIN without a same-design precedent to benchmark its comparative efficacy result against, and the eventual readout would be the first data point establishing how this device stacks up against the established surgical standard in this specific comparison.
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.