Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Vanquish System

• Registration Number: NCT05683691
• Lead Sponsor: Francis Medical Inc.

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 available

Study Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-13
• Study Start: 2023-05-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vanquish System Treatment	Vanquish System	-

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	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.
Primary Effectiveness Endpoint	36 months	Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.

Secondary Outcome Measures

Name	Time	Method
Key Secondary Endpoint	36 months	The proportion of subjects free from impotence.

Trial Locations

Locations (26)

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

WK Advanced Urology Specialists; 🇺🇸 Shreveport, Louisiana, 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