Profound’s TULSA Procedure Outperforms Robotic Prostatectomy in Key Safety Metrics

Event summary

  • Profound’s CAPTAIN trial met its primary safety endpoint, showing TULSA Procedure’s superiority over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence at 6 months.
  • TULSA Procedure demonstrated 50% of patients preserving both erectile function and urinary continence vs. 24% after RP.
  • The trial enrolled 211 patients across 23 sites in the US, Canada, and Europe, exceeding its initial target.
  • Secondary oncologic outcomes for TULSA Procedure are pending and expected later in 2026.

The big picture

Profound’s CAPTAIN trial results position the TULSA Procedure as a potential paradigm shift in prostate cancer treatment, challenging the dominance of robotic radical prostatectomy. The study’s success in meeting safety endpoints could accelerate adoption of MRI-guided, incision-free therapies, particularly as healthcare systems prioritize patient quality of life and cost-effectiveness. The pending oncologic outcomes will be critical in determining the procedure’s long-term viability as a standard of care.

What we're watching

Clinical Superiority
Whether TULSA Procedure’s demonstrated superiority in functional outcomes will drive broader adoption among urologists and patients.
Regulatory Pathway
The pace at which Profound can leverage these results to update treatment guidelines and expand reimbursement coverage.
Market Expansion
How Profound will position TULSA Procedure against existing surgical and non-surgical prostate cancer treatments.