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NCT05027477 · ClinicalTrials.gov registry record · NA

A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

A NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Profound Medical.

Active
Registry status
NA
Development phase
201
Enrollment target
20
Study locations

NCT05027477: Active NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Profound Medical.

NCT05027477 is a NA study of Prostate Cancer and Prostate Adenocarcinoma that is active but no longer recruiting, run by Profound Medical. The registered enrollment target is 201 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05027477, a NA study of Prostate Cancer and Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by Profound Medical.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
201 participants
Enrollment target
20
Study locations

Study Summary

Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.

Primary Outcome

Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 5) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).

Interventions

  • DEVICE TULSA Procedure
  • DEVICE Radical Prostatectomy

Study Locations (20)

California

  • Atlantic Urology Medical Group - Long Beach
  • Urology Group of Southern California - Los Angeles
  • University of California, Los Angeles - Los Angeles
  • Comprehensive Urology Medical Group - Los Angeles
  • Alarcon Urology Center - Montebello
  • Pasadena Urological Medical Group - Pasadena
  • Stanford Cancer Center - Stanford

Arizona

  • Arizona State Urological Institute - Chandler
  • East Valley Urological Center - Mesa
  • Investigate MD - Scottsdale

Florida

  • Mayo Clinic Jacksonville - Jacksonville
  • Sarasota Memorial Health Care System - Sarasota

Texas

  • The University of Texas Southwestern Medical Center - Dallas
  • The Urology Place - San Antonio

Connecticut

  • Yale Cancer Center - New Haven

Indiana

  • Indiana University - Indianapolis

Maryland

  • Johns Hopkins School of Medicine - Baltimore

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2021-11-01
Est. Completion 2036-08-31
Phase NA
Profound Medical

4 total trials

What the registry record for NCT05027477 still lists

NCT05027477 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (67% lower).

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which TULSA Procedure is the first listed.

NCT05027477 names 20 study sites across 10 states, led by California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT05027477 about?

NCT05027477 is a clinical study titled "A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer". Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe c...

What is the current status of trial NCT05027477?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 201 participants. The study started on 2021-11-01. Estimated completion is 2036-08-31.

What conditions does trial NCT05027477 study?

This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma.

What interventions are being tested in trial NCT05027477?

The interventions under investigation include: TULSA Procedure (DEVICE), Radical Prostatectomy (DEVICE).

Who is sponsoring clinical trial NCT05027477?

This trial is sponsored by Profound Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05027477 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05027477's enrollment target sits among peer trials

201 220th of 735 higher than 516 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05027477, the US trial registry maintained by the National Library of Medicine. NCT05027477 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.