What does this research mean for the field?

MRI-guided transurethral ultrasound ablation (TULSA) results in lower blood loss, shorter hospital stays, and reduced post-operative pain compared to robot-assisted radical prostatectomy (RARP) for intermediate-risk prostate cancer. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This trial aims to compare the perioperative outcomes of MRI-guided TULSA and robot-assisted RARP in treating intermediate-risk prostate cancer.

March 4, 2026

Perioperative outcomes from a randomized controlled trial comparing MRI-guided transurethral ultrasound ablation (TULSA) to robot-assisted radical prostatectomy (RARP).

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This trial aims to compare the perioperative outcomes of MRI-guided TULSA and robot-assisted RARP in treating intermediate-risk prostate cancer.
Multi-center randomized controlled trial involving 211 men with treatment-naïve, organ-confined Grade Group 2 or 3 prostate cancer.
Participants were randomized 2:1 to receive TULSA or RARP without crossover.
Endpoints included pad-free urinary continence, erections, salvage treatment rates, and survival metrics.
Periprocedural metrics assessed included length of stay, blood loss, and patient-reported outcomes.
Median blood loss was significantly less for TULSA (0 mL) compared to RARP (100 mL).
Hospital stay duration was shorter for TULSA (0.29 days) than RARP (1.24 days).
Pain scores were lower for TULSA patients post-operatively, with a quicker return to health.
TULSA patients showed fewer extreme disabilities in mobility and self-care compared to RARP.

Resumen

369 Background: MRI-guided transurethral ultrasound ablation (TULSA) uses MRI to target, monitor, and control thermal ablation of prostate tissue with high intensity directional ultrasound, demonstrating favorable histologic control and preservation of genitourinary function in single-arm studies 1,2. CAPTAIN (NCT05027477) is a post-market, multi-center randomized controlled trial (RCT) of TULSA vs RARP for intermediate-risk prostate cancer, and is the first such study to meet its enrolment target. Here we compare baseline patient characteristics, treatment parameters, and periprocedural outcomes. Methods: CAPTAIN enrolled men with treatment-naïve, organ-confined, Grade Group 2 or 3 prostate cancer at 23 centers including academic and private clinics in the USA (20), Canada (2), and Finland (1). Patients were randomized 2:1 to TULSA or RARP, without crossover. Endpoints include pad-free urinary continence (EPIC) and erections sufficient for penetration (IIEF Q2) at 1 year, salvage treatment at 3 years, and survival to 10 years. Periprocedural metrics include length of stay, blood loss, catheter time, and 30-day patient diary (EQ-5D-5L, NRS pain score). Results: 211 patients were treated from Jan 2022 to Aug 2025 (70% TULSA, 30% RARP), surpassing the enrolment target of 201. Arms had similar baseline characteristics: median (IQR) age for TULSA vs. RARP was 63 (58–68) vs 65 (60–69) years (p=0.12), PSA was 6.5 (4.9–9.6) vs 7.2 (5.6–9.7) ng/mL (p=0.63), Grade Group 2/3 proportions were 76%/24% vs 77%/23% (p=0.88). RARP involved bilateral, unilateral, or no nerve sparing in 89%, 5.7%, and 5.7% of cases. TULSA ablation plans included whole-gland (68%) and ≥hemi-ablation (32%). Median (IQR) blood loss was lower during TULSA vs RARP: 0 (0–0) vs 100 (100–200) mL (p<0.001). Hospital stay was shorter for TULSA: 0.29 (0.27–0.32) vs 1.24 (1.12–1.36) days (p<0.001). Catheter duration was longer post-TULSA: 13 (11–15) vs 8 (8–10) days (p<0.001). Patients reported lower NRS pain scores after TULSA to post-operative day 6, and less decline in overall health on the EQ-5D-5L 0-100 visual analog scale over 30 days (p<0.05). Fewer patients reported extreme inability on EQ-5D-5L after TULSA vs RARP over the first month for mobility (0% vs 15%), self-care (1% vs 18%), and usual activities (18% vs 38%) (all p<0.05). Conclusions: CAPTAIN is the first multicenter RCT comparing ablation to radical prostate cancer treatment to meet its enrollment target. Early perioperative results from CAPTAIN demonstrate that TULSA had no blood loss or overnight hospitalization, reduced post-procedural pain, and faster return to baseline activities and overall health. Data collection to 1 and 3 years post-treatment continues to readout of the primary safety and oncological outcomes. 1 Klotz et al 2021, JUrol 205(3):769-779. 2 Eggener et al 2024, UrolOnc 42:S83. Clinical trial information: NCT05027477 .

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