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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05683691
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Francis Medical Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2023
First Posted Date  ICMJE January 13, 2023
Last Update Posted Date May 20, 2024
Actual Study Start Date  ICMJE May 16, 2023
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2023)
  • Primary Effectiveness Endpoint [ Time Frame: 36 months ]
    Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2023)		 Key Secondary Endpoint [ Time Frame: 36 months ]
The proportion of subjects free from impotence.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
Official Title  ICMJE Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, Multicenter, Single-Arm Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Device: Vanquish System
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
Study Arms  ICMJE Experimental: Vanquish System Treatment
Intervention: Device: Vanquish System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2023)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2029
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabrielle Robinson (763) 951-0370 grobinson@francismedical.com
Contact: Rachael Krzmarzick 763-607-5997 rkrzmarzick@francismedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05683691
Other Study ID Numbers  ICMJE 4760-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Francis Medical Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Francis Medical Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Francis Medical Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP