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Preston Sprenkle, MD, highlights trial of TULSA vs radical prostatectomy

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The trial has enrolled 201 patients with localized prostate cancer to date.

The TULSA procedure is being compared against radical prostatectomy for localized, intermediate-risk prostate cancer in the CAPTAIN trial (NCT05027477).1

In an interview during the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada, Preston C. Sprenkle, MD, highlighted the background, design, and preliminary takeaways from the study.

In total, the trial has enrolled 201 patients to date. To be eligible for enrollment, patients need to have NCCN intermediate-risk prostate cancer; up to stage cT2c, N0, M0 disease; ISUP grade group 2 or 3 disease; a prostate-specific antigen level of 20 ng/mL or lower; and a life expectancy greater than 10 years.

Those enrolled in the study will be randomly assigned to receive TULSA (n = 134) or radical prostatectomy (n = 67). The primary safety and efficacy end points are the proportion of patients who maintain both urinary continence and erectile potency and the proportion of patients free from treatment failure, respectively. Participants in the study may be followed for up to 10 years.

So far, Sprenkle says that one major difference between the 2 procedures is the time spent in the hospital.

“The TULSA procedure is an outpatient procedure, so I think that's the first main difference,” he explained. “These are high volume surgeons who do a lot of prostate surgery, but even then, we saw a significantly shorter time period that men were in the hospital.”

Sprenkle is an associate professor of urology at the Yale School of Medicine in New Haven, Connecticut.

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      Another difference, Sprenkle noted, was that blood loss was significantly lower among patients who underwent the TULSA procedure.

      He added, “The only puncture in the patient's skin is the IV being placed. Everything else uses natural orifices to complete the treatment, so there really was zero blood loss. That's another major difference between the 2.”

      REFERENCE
      1. A comparison of TULSA procedure vs. radical prostatectomy in participants with localized prostate cancer (CAPTAIN). ClinicalTrials.gov. Last updated February 21, 2025. Accessed May 8, 2025. https://clinicaltrials.gov/study/NCT05027477

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