TULSA preserves penile length vs robotic prostatectomy in CAPTAIN trial

Men with intermediate-risk localized prostate cancer treated with MRI-guided transurethral ultrasound ablation (TULSA) demonstrated no median change in penile length at 1 month, compared with a median 0.65-cm reduction following robotic radical prostatectomy (RP), according to a new analysis from the randomized phase 3 CAPTAIN trial (NCT05027477) presented at the 2026 Society of Robotic Surgery Annual Meeting in Fort Lauderdale, Florida.^1,2

The presentation was delivered by Xiaosong Meng, MD, PhD, assistant professor at UT Southwestern Medical Center. The findings add to previously reported quality-of-life data from the trial suggesting improved early functional outcomes with TULSA relative to surgery,³ although long-term oncologic efficacy data remain pending.

Related: TULSA shows improved early functional outcomes vs RP in localized prostate cancer

“Penile length is not something many men feel comfortable talking about, even in the absence of prostate disease,” said Arun Menawat, Profound Medical’s CEO and Chairman, in a news release from the company.² “Because the penis may be deeply tied to their identity, masculinity, and/or self-worth, even small amounts of penile shrinkage can cause men a lot of additional worry and distress. This new data points to the greater peace of mind that the TULSA procedure can deliver to patients by gently, safely, and precisely ablating prostate tissue while actively protecting surrounding structures.”

How was the CAPTAIN trial designed?

CAPTAIN (NCT05027477) is a level 1 post-market study and the first fully enrolled, multicenter randomized controlled trial to directly compare an ablative therapy with radical prostatectomy for localized prostate cancer. A total of 211 treatment-naïve men with International Society of Urological Pathology (ISUP) Grade Group 2 or 3 prostate cancer and prostate-specific antigen levels below 20 ng/mL were randomly assigned in a 2:1 ratio to receive whole-gland MRI-guided TULSA with the TULSA-PRO system (n = 148) or robotic RP (n = 63). Patients were enrolled at 23 high-volume centers in the United States, Canada, and Finland.

The trial's composite primary functional safety end point, assessed at 6 months, was preservation of both pad-free urinary continence (EPIC Q5) and erections sufficient for penetration (IIEF Q2). The primary oncologic end point will be evaluated at 3 years and is defined as freedom from additional prostate cancer treatment, metastatic disease, or prostate cancer-specific death. Patients will continue to be followed for up to 10 years.

What were the findings from the CAPTAIN trial?

The newly presented analysis showed no median change in penile length 1 month after TULSA, whereas patients undergoing robotic RP experienced a median reduction of 0.65 cm. Using a mixed-effects statistical model, investigators reported a statistically significant between-group difference of 0.42 cm favoring TULSA (P < .001).

Beyond functional outcomes, investigators reported several perioperative advantages for TULSA. Median intraprocedural blood loss was 0 mL with TULSA compared with 100 mL (IQR, 100 to 200 mL) following robotic RP (P < .001). Patients undergoing TULSA were typically discharged the same day (median hospital stay, 0.28 days vs 1.16 days for RP), experienced lower postoperative pain scores, and returned to baseline health status more rapidly as measured by the EQ-5D questionnaire (all P < .001).

Recovery also appeared faster following TULSA. Patients missed a median of 10 days of work compared with 19 days after robotic RP (P < .05). Hospitalization for complications within 90 days occurred in 0.7% of TULSA-treated patients vs 6.3% of surgical patients. One patient (1.6%) in the RP arm experienced a life-threatening complication requiring intensive care, whereas no such events occurred after TULSA.

The authors also added, “At 6 months, TULSA was superior to RP on the study’s primary functional safety end point, with 50% vs. 24% of patients preserving pad-free continence and erections sufficient for penetration (risk ratio, 2.1; P = .004).”

The TULSA-PRO system is currently indicated in the US for transurethral ultrasound ablation of prostate tissue.

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