Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

NCT05683691 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 4760-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.

  36 months

• Primary Safety Endpoint

  The proportion of subjects free from new or worsening urinary incontinence based on pad use at 12 months will be statistically compared to a performance goal.

  12 months

Secondary Outcomes (1)

• Key Secondary Endpoint

  36 months

Study Arms (1)

Vanquish System Treatment

EXPERIMENTAL

Device: Vanquish System

Interventions

Vanquish System DEVICE

Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.

Vanquish System Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years of age; with life expectancy of ≥10 years
• cc prostate size determined by MRI Central Imaging
• ≤15 ng/ml PSA
• Cancer stage less than or equal to T2c
• 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
• Subject is willing and able to adhere to specific protocol visits and required testing throughout study
• 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
• Able and willing to provide written consent to participate in the study.
• Subject is willing and able to be treated within 180 days after signing consent.

You may not qualify if:

• 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.
• Active or clinically chronic prostatitis or granulomatous prostatitis
• Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
• Any previous treatment for prostate cancer.
• Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS

Sponsors & Collaborators

• Francis Medical Inc.: lead

Study Sites (25)

Mayo Clinic- Phoenix

Phoenix, Arizona, 85054, United States

Location

Memorial Care

Laguna Hills, California, 92653, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Kasraeian Urology

Jacksonville, Florida, 32216, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Wichita Urology

Wichita, Kansas, 67226, United States

Location

Chesapeake Urology

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Corewell Health / William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic- Rochester

Rochester, Minnesota, 55905, United States

Location

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Northwell Health- Lenox Hill Hospital

New York, New York, 11222, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Houston Methodist Hospital and Research Institute

Houston, Texas, 77030, United States

Location

The Urology Place

San Antonio, Texas, 78240, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multicenter, Single-Arm Study

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: May 16, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)