NewsStocksProfound Medical Shares Rise After CAPTAIN Trial Data Show TULSA Quality-of-Life Benefits

Profound Medical Shares Rise After CAPTAIN Trial Data Show TULSA Quality-of-Life Benefits

Author: Blockonomi·

Key Takeaways

  • The CAPTAIN trial found no median change in penile length one month after the TULSA Procedure, compared with a median reduction of 0.65 centimetres for robotic radical prostatectomy.
  • Researchers reported a statistically significant between-group difference of 0.42 centimetres with a p-value below 0.001.
  • Earlier CAPTAIN safety data showed TULSA preserved erectile function and urinary continence better than robotic surgery at the six-month mark.
  • The prospective multi-centre trial enrolled 211 patients with localized intermediate-risk prostate cancer across 23 clinical sites in North America and Europe.
  • The trial's primary safety endpoint measures preservation of erectile function and urinary continence at one year, while the primary efficacy endpoint tracks freedom from additional treatment, metastases, or disease-related death over three years.
Profound Medical Shares Rise After CAPTAIN Trial Data Show TULSA Quality-of-Life Benefits

Profound Medical Corp. shares traded at C$10.45, up 8.18%, after the company released new data from the CAPTAIN clinical trial showing that the TULSA Procedure preserved penile length better than robotic radical prostatectomy.

The latest findings added to previously reported evidence that TULSA may be associated with improved quality-of-life outcomes after treatment. Profound Medical Corp., which trades as PRN.TO, presented the data during the Society of Robotic Surgery Annual Meeting in Fort Lauderdale.

Xiaosong Meng, MD, PhD, delivered the presentation using results from the ongoing Level 1 post-market CAPTAIN randomized controlled trial. The study compares whole-gland TULSA with robotic radical prostatectomy in men with localized intermediate-risk prostate cancer, a setting where treatment decisions often weigh cancer control against urinary, sexual, and other functional outcomes.

CAPTAIN data show penile-length preservation with TULSA

The updated analysis found no median change in penile length one month after the TULSA Procedure. By contrast, robotic radical prostatectomy was associated with a median penile length reduction of 0.65 centimetres.

Researchers said statistical analysis confirmed a significant difference between the two treatment groups. Using a mixed-effects model, they estimated a between-group difference of 0.42 centimetres. The study reported a p-value below 0.001, indicating strong statistical significance.

The new results strengthened the evidence for TULSA as a tissue-preserving treatment option. They also built on earlier CAPTAIN safety findings, which showed that TULSA preserved erectile function and urinary continence better than robotic surgery after six months.

With the latest analysis, the MRI-guided procedure added another quality-of-life measure in which it compared favourably with robotic radical prostatectomy.

Trial compares TULSA with robotic prostate surgery

CAPTAIN is a prospective, multi-centre randomized controlled trial designed to evaluate the safety and effectiveness of TULSA compared with robotic radical prostatectomy.

The study enrolled 211 patients at 23 clinical sites across North America and Europe, exceeding its original enrolment target of 201 participants. The trial includes men with organ-confined, intermediate-risk prostate cancer and Gleason Score 7 disease.

The primary safety endpoint measures preservation of both erectile function and urinary continence one year after treatment. The primary efficacy endpoint evaluates freedom from additional prostate cancer treatment, metastases, or disease-related death over three years.

Researchers are also evaluating secondary outcomes, including complication rates, histological failure, biochemical failure, and cost effectiveness. The trial is intended to provide a broad comparison of the two treatment approaches over time, with the one-year safety and three-year efficacy readouts set to be important measures for interpreting the durability of the early quality-of-life findings.

Profound Medical focuses on MRI-guided treatment platforms

Profound Medical develops MRI-guided treatment technologies for prostate disease and other medical conditions. Its flagship TULSA-PRO platform enables incision-free prostate tissue ablation under real-time MRI guidance.

The system allows physicians to perform whole-gland, partial-gland, or focal treatments while monitoring therapy throughout the procedure. The company says the technology supports personalised treatment and is designed to reduce complications commonly linked to surgery or radiation therapy, including urinary incontinence and erectile dysfunction.

The platform is focused on preserving surrounding healthy structures during treatment.

Profound also markets the Sonalleve system for MRI-guided non-invasive therapy. Sonalleve is used to treat osteoid osteoma, bone metastasis pain, desmoid tumours, uterine fibroids, and adenomyosis in approved markets. The company continues to evaluate the platform for abdominal cancer treatment and hyperthermia-based cancer therapies.