🏛️ Verified NIH Record • Updated 2026-06-11

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (NCT05683691)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Francis Medical Inc.

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (23 items).

Location: Mayo Clinic- Phoenix — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients with \>GGG3 cores anywhere in the prostate
  • MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE)
  • All MRI Central Imaging confirmed PI-RADS 5 lesions
  • All MRI Central Imaging confirmed additional PI-RADS 4 lesions.
  • Contraindications to MRI
  • Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.
  • Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
  • Treated within the past 5 years for genital cancer
  • Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use
  • Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for \<6 months, 6-month washout), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout), or Testosterone supplementation (3-month washout)
  • Active urinary tract infection. Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (25 Sites)

  • Mayo Clinic- Phoenix — Phoenix, Arizona
  • Memorial Care — Laguna Hills, California
  • University of Southern California — Los Angeles, California
  • Kasraeian Urology — Jacksonville, Florida
  • University of Chicago — Chicago, Illinois
  • Wichita Urology — Wichita, Kansas
  • Chesapeake Urology — Baltimore, Maryland
  • Johns Hopkins — Baltimore, Maryland
  • Corewell Health / William Beaumont University Hospital — Royal Oak, Michigan
  • Michigan Institute of Urology — Troy, Michigan
  • University of Minnesota — Minneapolis, Minnesota
  • Mayo Clinic- Rochester — Rochester, Minnesota
  • Minnesota Urology — Woodbury, Minnesota
  • NYU Langone Health — New York, New York
  • Northwell Health- Lenox Hill Hospital — New York, New York
  • University of Rochester — Rochester, New York
  • Duke Cancer Institute — Durham, North Carolina
  • The Urology Group — Cincinnati, Ohio
  • MidLantic Urology — Bala-Cynwyd, Pennsylvania
  • Carolina Urologic Research Center — Myrtle Beach, South Carolina
  • Urology Austin — Austin, Texas
  • Houston Methodist Hospital and Research Institute — Houston, Texas
  • The Urology Place — San Antonio, Texas
  • Urology of Virginia, PLLC — Virginia Beach, Virginia
  • Medical College of Wisconsin — Milwaukee, Wisconsin

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗