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

Early results from the randomized phase 3 CAPTAIN trial (NCT05027477) suggest that MRI-guided transurethral ultrasound ablation (TULSA) may offer improved short-term functional outcomes compared with robotic-assisted radical prostatectomy (RP) in men with organ-confined, intermediate-risk prostate cancer.

Six-month data presented at the 41st Annual Congress of the European Association of Urology in London, UK, showed higher rates of preserved urinary continence and erectile function among patients treated with the minimally invasive ablative procedure, although oncologic outcomes remain pending.¹ The findings were presented by Laurence Klotz, CM, MD, FRCSC, a professor of surgery at the University of Toronto and chair in prostate cancer research at Sunnybrook Health Sciences Center.

“CAPTAIN is a first-of-its-kind study, successfully recruiting patients into a head-to-head comparison of the TULSA procedure and robotic RP for both safety and oncologic control, “ Klotz explained in a press release on the results. “The study tests whether the TULSA procedure is superior to RP for functional outcomes and not inferior to RP for oncologic control. Establishing these outcomes would facilitate moving the TULSA procedure into the standard of care.”

The CAPTAIN trial is a prospective, multicenter randomized controlled study evaluating MRI-guided TULSA vs RP in men with organ-confined, intermediate-risk prostate cancer. The trial enrolled 211 patients across multiple international centers and randomized participants in a 2:1 fashion to the TULSA procedure (n = 148) or surgery (n = 63).

Patients were eligible for the trial if they had grade group 2 or 3 disease (Gleason score 7) and prostate-specific antigen levels of 20 ng/mL or lower. Investigators excluded individuals with large intraprostatic calcifications or tumors located more than 3 cm from the urethra, since these factors can limit the reach of ultrasound energy. Baseline characteristics were well-balanced between both arms.

During the presentation, Klotz emphasized the logistical challenges of conducting randomized trials comparing surgery with minimally invasive therapies.

“This study, called the CAPTAIN trial, is the first fully recruited, multi center randomized trial comparing an ablative therapy to radical prostatectomy. And although it's very difficult to pull off a trial like this, it was quite successful in terms of accrual,” Klotz said.

The trial has 2 co-primary end points: a functional safety end point and an oncologic efficacy end point. Functional outcomes—including urinary continence and erectile function—are being evaluated at 1 year, while the primary oncologic end point (percentage of patients free of salvage, metastasis, and prostate cancer-related death) will be assessed at 3 years. Patients are expected to be followed for up to 10 years to evaluate long-term cancer control.

At 6 months, TULSA demonstrated superior outcomes on several functional measures compared with robotic prostatectomy. Recovery of urinary continence was reported in 84% of patients in the TULSA arm compared with 49% of those who underwent surgery. Erectile function recovery was reported in 56% of patients in the TULSA arm vs 47% of patients in the RP arm.

“These are early results,” Klotz noted. “One would expect both of these parameters to improve over time with both treatments.”

The composite end point combining preserved erectile function and continence was achieved in 50% of patients treated with TULSA compared with 24% of those treated with radical prostatectomy (risk ratio, 2.1; P < .05).

Perioperative outcomes also differed substantially between groups. As a transurethral, incision-free procedure performed under MRI guidance, TULSA was associated with no blood loss and was performed as an outpatient procedure (median periprocedural length of stay of 0.3 days). In contrast, robotic prostatectomy involved a median blood loss of approximately 150 mL and a median hospital stay of about 1 day.

“[This is] really quite impressive from a surgical perspective, but considerably longer than TULSA,” Klotz noted.

Patients undergoing TULSA also reported lower pain scores during the first postoperative week as well as better preservation of patient-reported overall health following treatment. Patients in the TULSA arm also reported significantly less time missed from paid employment in the 30 days following the procedure, with a median of 10 days (range, 4 to 15) before returning to work in the TULSA arm vs 19 days (range, 10 to 41) in the RP arm (P < .05)

Serious complications requiring hospitalization occurred in approximately 0.7% of patients treated with TULSA compared with 6.3% of patients in the surgical arm (P < .05). No patients required ICU admission after TULSA compared with 1.6% of patients following RP.

Despite the favorable early functional outcomes, oncologic efficacy results from the TULSA arm have not yet been reported. RP results are available through surgical pathology, which showed that roughly 33% of patients had a positive surgical margin and 35% were upstaged.

“We only have the oncologic outcomes after surgery,” Klotz said. “The oncologic outcome after TULSA is primarily a function of MRI showing residual disease and biopsy, which is mandated on all patients at 1 year, and we don't have that yet.”

According to Profound Medical, the first oncologic results are expected to be shared later this year following mandatory 12-month imaging and biopsy assessments.²

“We have reached a foundational milestone by proving superior safety,” Klotz concluded in the news release. “At 6 months, patients treated with TULSA-PRO were more than twice as likely to preserve both pad-free continence and erections sufficient for intercourse compared to surgery, delivering functional outcomes that track the established body of evidence for the TULSA procedure. The TULSA procedure also proved a less invasive experience marked by zero blood loss and no overnight stay, faster recovery to baseline, day-to-day activities and return to work, and significantly fewer, serious complications. Secondary oncologic end points available later this year for the TULSA procedure arm will serve as a window into the 3-year primary oncologic end point.”

Editor’s Note: Laurence Klotz reports disclosures with Profound Medical.

REFERENCES

1. Klotz LH, Meng X, Lotan Y, et al. Randomized controlled trial evaluating MRI-guided transurethral ultrasond ablation (TULSA) versus robotic prostatectomy: Initial perioperative outcomes. Presented at: 41st Annual Congress of the European Association of Urology. London, UK. March 13-16, 2026. Abstract LB005

2. 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. News release. Profound Medical. March 13, 2026. Accessed March 15, 2026. https://ir.profoundmedical.com/news-events/press-releases/detail/169/captain-trial-comparing-profounds-mri-guided-tulsa-procedure-to-robotic-radical-prostatectomy-successfully-meets-primary-safety-endpoint-preservation-of-erectile-function-and-urinary-continence