50 - Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) vs Robotic Prostatectomy for Intermediate-Risk Prostate Cancer: Ablation Parameters and Initial Perioperative Outcomes

Sunday, April 12, 2026

4:21 PM - 4:30 PM ET

Presenting Author(s)

David A. Woodrum, MD, PhD, FSIR (he/him/his)

Professor of Radiology
Mayo Clinic, United States

Author/Co-author(s)

LM

Lance A. Mynderse, MD, MS

Associate Professor in Urology & Radiology
Mayo Clinic, United States
Steven S. Raman, MD, FSIR

Professor of Radiology, Urology and Surgery
David Geffen School of Medicine At UCLA, United States
DS

David Sella, MD

Interventional Radiologist
Mayo Clinic Florida, United States
GF

Gregory T. Frey, MD MPH

Assistant Professor
Mayo Clinic, United States
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology
Stanford University Medical Center, United States
SA

Sandeep Arora, MD

Associate Professor of Radiology and Biomedical Imaging
Yale School of Medicine, United States
RP

Robert Princenthal, MD

Radiologist and Director of RadNet Prostate Program
Radnet Imaging, United States
MC

Martin Cohen, MD

Radiologist
Radnet Rolling Oaks, United States
KM

Katarzyna J. Macura, MD, PhD

Professor of Radiology and Radiological Science
The Russell H. Morgan Department of Radiology and, United States
TT

Temel Tirkes, MD

Associate Professor of Radiology and Imaging Sciences
Indiana University, United States
Joseph J. Busch, Jr., MD

Oncological Radiologist
Busch Center, United States
AP

Andrei Purysko, MD

Associate Professor of Radiology
Cleveland Clinic, United States
PM

Pietari Makela, MD, PhD

Radiology
University of Turku, Finland
XM

Xiaosong Meng, MD, PhD

Assistant Professor, Urology
UT Southwestern Medical Center, United States
PS

Preston Sprenkle, MD

Associate Professor of Urology
Yale School of Medicine, United States
NK

Naveen Kella, MD

Director
The Urology Place, United States
GS

Geoffrey Sonn, MD

Associate Professor of Urology and Radiology
Stanford, United States
GC

Gina M. Clarke, PhD

Manager, Clinical Science
Profound Medical, Canada
RS

Robert Staruch, PhD

Director of Clinical Science
Profound Medical, Canada
DC

Daniel Costa, MD

Associate Professor of Radiology
UT Southwestern Medical Center, United States

Purpose: Randomized trials comparing ablation to standard prostate cancer (PCa) treatment have historically failed to recruit. The CAPTAIN randomized controlled trial (NCT05027477) compares TULSA to robotic prostatectomy (RP) for localized, intermediate-risk prostate cancer. Primary endpoints are urinary continence, erectile function, and freedom from salvage treatment. Here we present baseline patient/treatment characteristics, and initial perioperative outcomes/return to baseline activity.

Materials and Methods: Patients were randomized between TULSA and RP in 2:1 ratio. Key eligibility criteria included intraprostatic calcifications ≤3 mm on CT or MRI, and Gleason 7 biopsy-positive PCa. RP was performed per local standard of care; TULSA included hemi- to whole-gland ablation. Data collection included: ablation fraction (TULSA); lymph node dissection (RP); hospitalization, blood loss, 30-day diaries tracking pain and return to normal activity (both arms).

Results: From Jan 2022 to Aug 2025, 212 patients (148 TULSA; 64 RP) were treated across 23 sites, surpassing the 201 target. For TULSA vs RP: median (IQR) age was 63 (58-68) vs 65 (60-69) y (p=0.12); PSA 6.5 (4.9-9.6) vs 7.2 (5.6-9.7) ng/ml (p=0.63); prostate volume 41 (31-50) vs 35 (29-47) cc (p=0.10). Prostate calcifications were absent/≤3mm/ >3mm in 64%/19%/17% vs 67%/22%/11% (all p >0.05). TULSA vs RP patients with Grade Group 2/3 histology: 76%/24% vs 77%/23% (p=0.88). Most TULSA plans were designed for subtotal ablation with strategic sparing; median (IQR) fraction of the prostate heated to ablative temperatures measured by intraprocedural MRI thermometry was 78% (71%-85%). For RP, 77% had pelvic lymph node dissection. There was significantly less intraprocedural blood loss after TULSA vs RP [0 (0-0) vs 100 (100-200) mL] and shorter stay [0.29 (0.27-0.32) vs 1.24 (1.12-1.36) days], both p< 0.001. Catheterization was longer after TULSA, 13 (11-15) vs 8 (8-10) d. Patients reported significantly less decline in overall health on the EQ-5D 0-100 visual analog scale after TULSA vs RP for all 30 d.

Conclusion: Initial perioperative outcomes demonstrate that TULSA had no blood loss, no overnight stay, reduced post-procedure pain, and faster recovery to baseline activities and overall health compared to RP.