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TULSA vs. Surgery: Prostate Cancer Trial Shows Early Positive Results

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Early results of a randomized clinical trial evaluating a new prostate cancer treatment are promising, say Yale physician-scientists who are part of the international study.

The trial, known as CAPTAIN, continues to follow more than 200 participants. They received either a new minimally invasive treatment for intermediate-risk prostate cancer known as TULSA (MRI-guided transurethral prostate ablation), or standard robotic prostate removal surgery. CAPTAIN is the first randomized trial to reach full patient enrollment that compares surgery and ablation therapy.

What is TULSA?

With TULSA, a device is inserted through the urethra that sends high-energy sound waves into the prostate, causing the heating and death of cancer cells. The procedure is performed under real-time MR imaging guidance, which aids in visualization and precise targeting of the cancer. The goal is to destroy cancerous tissue without affecting healthy organs nearby.

“It has been very rewarding to contribute to the development and improvement of this technology from the beginning,” says Sandeep Arora, MBBS, MD. The Yale associate professor of radiology and biomedical imaging has been developing and refining the procedure since 2016 and was involved in the first two whole-gland prostate TULSA cases performed in the world.

Early Clinical Trial Findings

Short-term results recently presented at the annual meeting of the Society of Interventional Radiology (SIR), and published in the Journal of Vascular and Interventional Radiology, showed TULSA was associated with less blood loss, a shorter hospital stay, reduced pain, and better overall patient-reported health outcomes. Preliminary findings were first presented in December 2025 at the annual meeting of the Society of Urologic Oncology (SUO).

“The initial results are exciting and confirm the reduced immediate side effects of ablation therapy compared to radical therapy like prostate surgery,” says Preston Sprenkle, MD, lead Yale urologic oncologist connected with the trial.

Yale Expertise in Ablation Therapies

In 2021, Yale was among the first centers in the country to offer the TULSA procedure to patients with prostate cancer. Under Sprenkle’s leadership, it is a collaborative urology and radiology effort, including Arora, Michael Leapman, MD, MHS, and Jessica Lee, MD. They have built one of the most prolific prostate ablation programs in the Northeast, which includes TULSA, cryoablation, and irreversible electroporation (which uses electricity to target cancer).

What's Next?

In the coming months, investigators will analyze rates of bladder control and sexual function one year after treatment, comparing outcomes between participants who underwent TULSA and those who had their prostate surgically removed.

"Preventing cancer progression remains a primary goal as well, with more definitive results expected in 2027," says Sprenkle, who is a member of Yale Cancer Center.

“It gives me great personal pride and satisfaction to be able to offer this option to the Yale patient community, especially since TULSA has already demonstrated promising short-term results for those with prostate cancer,” explains Arora.

Providers emphasize that more treatment options give patients greater control over how they choose to treat the cancer and protect their quality of life.

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Author

Cheri Lewis
Communications Officer

Funding for this study was provided by Profound Medical Inc.

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CAPTAIN Trial Details

from clinicaltrials.gov

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