Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05683691

Run by

Francis Medical Inc.

People needed

400

Starts

2023-05-16

Expected to finish

2029-04-01

Last updated by the study team

2026-06-15

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ≥50 years of age; with life expectancy of ≥10 years
• 20-80 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
• Unable to stop taking antiplatelet medications or other blood thinning agents
• Known allergy to nickel
• Allergic to medication required by the study such as MRI contrast or anesthesia
• Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
• Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires
• Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
• Subject is considered vulnerable such as incarcerated or cognitively impaired.

Where it is running

• 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
• Chesapeake Urology — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Corewell Health / William Beaumont University Hospital — Royal Oak, Michigan, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic- Rochester — Rochester, Minnesota, United States
• Minnesota Urology — Woodbury, Minnesota, United States
• NYU Langone Health — New York, New York, United States
• Northwell Health- Lenox Hill Hospital — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• The Urology Group — Cincinnati, Ohio, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Austin — Austin, Texas, United States
• Houston Methodist Hospital and Research Institute — Houston, Texas, United States
• The Urology Place — San Antonio, Texas, United States
• Urology of Virginia, PLLC — Virginia Beach, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.