Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

— VAPOR 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683691
• Other study ID #: 4760-001
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: April 2029

Study information

• Verified date: June 2024
• Source: Francis Medical Inc.
• Contact: Gabrielle Robinson
• Phone: (763) 951-0370
• Email: grobinson[@]francismedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2029
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Vanquish System
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.

Locations

Country	Name	City	State
United States	Urology Austin	Austin	Texas
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Chesapeake Urology	Baltimore	Maryland
United States	Johns Hopkins	Baltimore	Maryland
United States	Baptist Health	Boynton Beach	Florida
United States	University of Chicago	Chicago	Illinois
United States	Associated Urological Specialists	Chicago Ridge	Illinois
United States	The Urology Group	Cincinnati	Ohio
United States	Duke Cancer Institute	Durham	North Carolina
United States	Houston Methodist Hospital and Research Institute	Houston	Texas
United States	Kasraeian Urology	Jacksonville	Florida
United States	Memorial Care	Laguna Hills	California
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Northwell Health- Lenox Hill Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	Mayo Clinic- Phoenix	Phoenix	Arizona
United States	Mayo Clinic- Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Corewell Health / William Beaumont University Hospital	Royal Oak	Michigan
United States	The Urology Place	San Antonio	Texas
United States	WK Advanced Urology Specialists	Shreveport	Louisiana
United States	WMC Health- Good Samaritan Hospital	Suffern	New York
United States	Michigan Institute of Urology	Troy	Michigan
United States	Arizona Urology Specialists	Tucson	Arizona
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Wichita Urology	Wichita	Kansas
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Francis Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG=2.	36 months
Primary	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	Key Secondary Endpoint	The proportion of subjects free from impotence.	36 months