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NewsMacro · PROF

PROF in focus: CAPTAIN trial data shows TULSA ablation outperforms robotic RP on penile length preservation

New penile length data from the Level 1 CAPTAIN randomized controlled trial put PROF in focus Friday, with Profound Medical Corp. (NASDAQ: PROF; TSX: PRN) reporting no median change in penile length at one month after the TULSA Procedure, against a median 0.65 cm reduction following robotic radical prostatectomy. The between-arm difference, estimated at 0.42 cm via mixed-effects model, cleared statistical significance at p<0.001. The three-year primary efficacy endpoint, which tracks freedom from additional prostate cancer treatment and prostate cancer-related death, is the next definitive read for the setup.

By Lena ParkMacro DeskJuly 24, 20262 min readPROF
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Key takeaways

  • In the Level 1 CAPTAIN randomized trial, the TULSA Procedure showed no median change in penile length at one month, versus a median 0.65 cm reduction after robotic radical prostatectomy.
  • The between-arm penile length difference was estimated at 0.42 cm (mixed-effects model) and was statistically significant at p<0.001.
  • CAPTAIN treated 211 patients (exceeding its 201 target) by August 2025 across 20 U.S. sites, two in Canada, and one in Europe, in men with organ-confined, intermediate-risk, Gleason Score 7 prostate cancer.
  • The trial's three-year primary efficacy endpoint—freedom from additional prostate cancer treatment, metastases, and prostate cancer-related death—is the next definitive milestone and will test TULSA's oncologic non-inferiority claim.
  • TULSA previously showed statistically significant superiority over robotic RP in preserving erectile function and urinary continence at six months.

New penile length data from the Level 1 CAPTAIN randomized controlled trial put PROF in focus Friday, with Profound Medical Corp. (NASDAQ: PROF; TSX: PRN) reporting no median change in penile length at one month after the TULSA Procedure, against a median 0.65 cm reduction following robotic radical prostatectomy. The between-arm difference, estimated at 0.42 cm via mixed-effects model, cleared statistical significance at p<0.001. The three-year primary efficacy endpoint, which tracks freedom from additional prostate cancer treatment and prostate cancer-related death, is the next definitive read for the setup.

Trial design and where the results landed

CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is a prospective, multi-center randomized controlled trial in men with organ-confined, intermediate-risk, Gleason Score 7 prostate cancer. The trial exceeded its enrollment target, treating 211 patients instead of the planned 201, by August 2025 at 20 U.S. sites, two in Canada, and one in Europe.

Xiaosong Meng, MD, PhD, an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, presented the one-month penile length findings Friday at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, Florida. The data had not been publicly disclosed before that presentation.

The result in context

The penile length finding builds on Profound's previously announced primary safety endpoint results, in which TULSA demonstrated statistically significant superiority over robotic RP in preserving both erectile function and urinary continence at six months. Together, the quality-of-life data points form a record that the TULSA Procedure can ablate prostate tissue while limiting side effects on surrounding structures, a central claim in the company's commercial thesis.

Profound CEO and Chairman Arun Menawat noted that penile dimensions can carry weight beyond the physical for men, tying to identity and self-worth. Even small reductions, in his view, generate worry and distress. The new data, he said, points to the greater peace of mind the TULSA Procedure can deliver to patients.

What to watch

The trial's primary efficacy endpoint measures freedom from additional prostate cancer treatment, freedom from metastases, and prostate cancer-related death at three years post-treatment. That read, which will test TULSA's non-inferiority claim on the oncologic side, is the next hard milestone for PROF. The one-year primary safety endpoint, covering erectile potency and urinary continence preservation, also remains outstanding in the trial timeline.

TULSA-PRO carries FDA clearance for transurethral ultrasound ablation of prostate tissue in the United States.

About this story

Filed by the macro desk of MarketPR on July 24, 2026. Source: MarketPR. Indicative figures are not investment advice.

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Frequently asked

Who presented the penile length findings and where?

Xiaosong Meng, MD, PhD, an Assistant Professor of Urology at UT Southwestern Medical Center, presented the one-month findings Friday at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, Florida.

What company is behind the TULSA Procedure?

Profound Medical Corp. (NASDAQ: PROF; TSX: PRN), whose CEO and Chairman is Arun Menawat, reported the data.

What is the CAPTAIN trial comparing?

CAPTAIN is a prospective, multi-center randomized controlled trial comparing the TULSA Procedure versus robotic radical prostatectomy in men with localized, intermediate-risk, Gleason Score 7 prostate cancer.

Is the TULSA Procedure FDA cleared?

Yes, TULSA-PRO carries FDA clearance for transurethral ultrasound ablation of prostate tissue in the United States.

What trial results are still outstanding?

The three-year primary efficacy endpoint and the one-year primary safety endpoint (covering erectile potency and urinary continence preservation) both remain outstanding.