Trial Supports MRI-guided TULSA Procedure for Prostate Cancer Safety

A newer, minimally invasive approach to treating prostate cancer may help patients maintain quality of life without compromising safety, according to findings from the CAPTAIN trial. The study compared the MRI-guided transurethral ultrasound ablation (TULSA) procedure with robotic radical prostatectomy and found that TULSA met its primary safety goal: preserving both erectile function and urinary continence.

These early results are especially meaningful for patients with localized prostate cancer who are weighing treatment options that may affect long-term quality of life. Surgery remains a standard approach, but it can carry risks such as erectile dysfunction and urinary incontinence. The CAPTAIN trial suggests that TULSA may offer a less invasive alternative that reduces these risks.

“CAPTAIN is a Level 1 study designed to provide the first true apples-to-apples comparison of the safety, quality of life and oncological control of two prostate cancer treatment modalities,” said Arun Menawat, Profound’s CEO and chairman. “CAPTAIN now positions us to demonstrate with statistical rigor the TULSA Procedure’s superior quality of life profile while delivering the whole-gland treatment efficacy of robotic RP. We look forward to announcing additional clinical outcomes from this unique, potentially paradigm-changing study when they become available later this year.”

TULSA preserves function in prostate cancer treatment

The CAPTAIN trial focused on whether patients could maintain key functions after treatment. Specifically, researchers evaluated erectile function and pad-free urinary continence at one year.

The trial met its primary safety end point, demonstrating that TULSA preserved these functions more effectively than surgery. This aligns with earlier observations that minimally invasive, MRI-guided therapies may better protect surrounding healthy tissue.

Additional early findings from the study showed that patients undergoing TULSA experienced less blood loss, shorter hospital stays and improved recovery compared with those who underwent prostatectomy.

Patients treated with TULSA were often discharged the same day, whereas surgery typically required at least an overnight hospital stay. Pain levels were also lower during the first week of recovery, although differences between groups evened out after several weeks.

These findings highlight a potential advantage for patients seeking quicker recovery and fewer immediate side effects.

Understanding treatment options for localized prostate cancer

For men diagnosed with localized, intermediate-risk prostate cancer, radical prostatectomy has long been a standard treatment. This surgery removes the prostate gland and can effectively control cancer. However, it may also lead to lasting side effects, particularly affecting urinary and sexual function.

As a result, researchers have explored less invasive options that aim to treat the cancer while preserving quality of life. One such approach is TULSA, which uses real-time MRI guidance to deliver targeted ultrasound energy that destroys cancer tissue.

Because TULSA is performed through the urethra rather than through surgical incisions, it is considered minimally invasive. This allows for more precise treatment and may reduce damage to nearby structures that are important for urinary and sexual function.

CAPTAIN trial design and patient population

The CAPTAIN trial is a multicenter, randomized controlled study designed to directly compare TULSA with robotic radical prostatectomy in men with localized prostate cancer.

Approximately 201 patients are expected to enroll, with participants randomly assigned to receive either TULSA or surgery.

Eligible patients include men with intermediate-risk prostate cancer, specifically those with grade group 2 or 3 disease that has not spread beyond the prostate.

The study is designed to follow patients for up to 10 years to evaluate both short-term safety outcomes and long-term cancer control. Researchers are also examining whether patients remain free from treatment failure, defined as the need for additional therapy, disease progression or death related to cancer.

Additional findings and what comes next

Beyond the primary safety findings, the CAPTAIN trial is expected to provide important insights into how well TULSA controls cancer over time. Long-term data on cancer outcomes, including recurrence and metastasis, are still being collected.

Earlier studies of TULSA have shown encouraging results, including high rates of preserved urinary continence and erectile function, as well as meaningful reductions in cancer burden.

The CAPTAIN trial is particularly significant because it is one of the first randomized, head-to-head comparisons of a minimally invasive therapy with standard surgery. This type of data is considered high-quality evidence and may help guide future treatment recommendations.

If longer-term results confirm these early findings, TULSA could become an important option for patients who want effective cancer treatment without sacrificing quality of life. For many individuals, the ability to maintain normal urinary and sexual function may play a critical role in treatment decisions.

As research continues, patients are encouraged to speak with their care team about clinical trials and emerging therapies that may be appropriate for their specific diagnosis and goals.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

References

1. “CAPTAIN Trial Comparing Profound’s MRI-Guided TULSA Procedure™ to Robotic Radical Prostatectomy Successfully Meets Primary Safety Endpoint, Preservation of Erectile Function and Urinary Continence,” by Profound Medical Corp. News release; March 13, 2026.

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