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

March 27, 2024 updated by: Francis Medical Inc.

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic- Phoenix
        • Principal Investigator:
          • Daniel Frendl, MD
        • Contact:
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Urology Specialists
        • Principal Investigator:
          • Kalpesh Patel, MD
        • Contact:
    • California
      • Laguna Hills, California, United States, 92653
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Andre Abreu, MD
    • Florida
      • Boynton Beach, Florida, United States, 232435
        • Not yet recruiting
        • Baptist Health
        • Contact:
        • Principal Investigator:
          • Raymond Leveillee, MD
      • Jacksonville, Florida, United States, 32216
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago Ridge, Illinois, United States, 60615
        • Recruiting
        • Associated Urological Specialists
        • Principal Investigator:
          • Aaron Berger, MD
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Principal Investigator:
          • Arvin George, MD
        • Contact:
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology
        • Principal Investigator:
          • Richard Levin, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology
        • Contact:
        • Principal Investigator:
          • Kenneth Kernen, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Christopher Warlick, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic- Rochester
        • Principal Investigator:
          • Lance Mynderse, MD
        • Contact:
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Urology
        • Contact:
        • Principal Investigator:
          • Aaron Milbank, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Samir Taneja, MD
      • New York, New York, United States, 11222
        • Recruiting
        • Northwell Health- Lenox Hill Hospital
        • Principal Investigator:
          • Ivan Grunberger, MD
        • Contact:
      • Rochester, New York, United States, 14620
      • Suffern, New York, United States, 10901
        • Recruiting
        • WMC Health- Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Mitchell Fraiman, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
        • Principal Investigator:
          • Thomas Polascik, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • The Urology Group
        • Contact:
        • Principal Investigator:
          • Marc Pliskin, DO
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Principal Investigator:
          • Neal Shore, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78745
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Hospital and Research Institute
        • Principal Investigator:
          • Brian Miles, MD
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • The Urology Place
        • Principal Investigator:
          • Naveen Kella, MD
        • Contact:
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Arjun Sivaraman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 10-16 cores.
  6. <15mm diameter of qualifying lesion as measure by greatest diameter
  7. Subject is willing and able to adhere to specific protocol visits and required testing throughout study
  8. 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
  9. Able and willing to provide written consent to participate in the study.

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 PI-RADS 5 lesions
  4. All MRI Central Imaging confirmed by PI-RADS 4 lesions negative on biopsy
  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), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or Testosterone supplementation
  11. Active urinary tract infection
  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 (excluding prostate cancer meeting the inclusion criteria)
  14. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
  15. Unable to stop taking antiplatelet medications or other blood thinning agents
  16. Known allergy to nickel
  17. Allergic to medication required by the study such as MRI contrast or anesthesia
  18. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
  19. 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
  20. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
  21. Subject is considered vulnerable such as incarcerated or cognitively impaired.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 36 months
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
36 months
Primary Safety Endpoint
Time Frame: 12 months
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
Time Frame: 36 months
The proportion of subjects free from impotence.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francis Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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