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Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer | Clinical Trials | Clareo Health

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Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR

NCT05683691•Francis Medical Inc.

Summary

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.

Eligibility

Age

50 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. ≥50 years of age; with life expectancy of ≥10 years
•2. 20-80 cc prostate size determined by MRI Central Imaging
•3. ≤15 ng/ml PSA
•4. Cancer stage less than or equal to T2c
•5. Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining a minimum of 10 cores.
•* \<15mm diameter of qualifying lesion as measure by greatest diameter
•6. Subject is willing and able to adhere to specific protocol visits and required testing throughout study
•7. Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment
•8. Able and willing to provide written consent to participate in the study.
•9. Subject is willing and able to be treated within 180 days after signing consent.

Exclusion Criteria

•1. Patients with \>GGG3 cores anywhere in the prostate
•2. MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE)
•3. All MRI Central Imaging confirmed PI-RADS 5 lesions
•4. All MRI Central Imaging confirmed additional PI-RADS 4 lesions.
•5. Contraindications to MRI
•6. 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.
•7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
•8. Treated within the past 5 years for genital cancer
•9. Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use
•10. 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)
+12 more criteria

Locations (26)

Mayo Clinic- Phoenix

Phoenix, Arizona, United States

Memorial Care

Laguna Hills, California, United States

University of Southern California

Los Angeles, California, United States

Kasraeian Urology

Jacksonville, Florida, United States

University of Chicago

Chicago, Illinois, United States

Wichita Urology

Wichita, Kansas, United States

WK Advanced Urology Specialists

Shreveport, Louisiana, United States

Chesapeake Urology

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Corewell Health / William Beaumont University Hospital

Royal Oak, Michigan, United States

Key Dates

Start Date

May 16, 2023

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2029

Last Updated

March 2, 2026

Enrollment

400

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Vanquish System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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