Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Vanquish System

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic- Phoenix
  • California
    • Laguna Hills, California, United States, 92653
      • Memorial Care
    • Los Angeles, California, United States, 90089
      • University of Southern California
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Kasraeian Urology
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health / William Beaumont University Hospital
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic- Rochester
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Urology
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 11222
      • Northwell Health- Lenox Hill Hospital
    • Rochester, New York, United States, 14620
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Austin, Texas, United States, 78745
      • Urology Austin
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital and Research Institute
    • San Antonio, Texas, United States, 78240
      • The Urology Place
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)
11. 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.
12. Active or clinically chronic prostatitis or granulomatous prostatitis
13. Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
14. Any previous treatment for prostate cancer.
15. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
16. Unable to stop taking antiplatelet medications or other blood thinning agents
17. Known allergy to nickel
18. Allergic to medication required by the study such as MRI contrast or anesthesia
19. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
20. 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
21. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
22. Subject is considered vulnerable such as incarcerated or cognitively impaired.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vanquish System Treatment	Device: Vanquish System; Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Secondary Endpoint	The proportion of subjects free from impotence.	36 months

Collaborators and Investigators

• Sponsor: Francis Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Acetaminophen, aspirin, caffeine drug combination
• Other Study ID Numbers: 4760-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No