Clinical trial NCT05683691: Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
Official title: Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Francis Medical Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 400
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Multicenter, Single-Arm Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 36 months
measure: Primary Safety Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Key Secondary Endpoint
timeFrame: 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic- Phoenix
state: Arizona
city: Laguna Hills
country: United States
facility: Memorial Care
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Jacksonville
country: United States
facility: Kasraeian Urology
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Wichita
country: United States
facility: Wichita Urology
state: Kansas
city: Shreveport
country: United States
facility: WK Advanced Urology Specialists
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Royal Oak
country: United States
facility: Corewell Health / William Beaumont University Hospital
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic- Rochester
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Northwell Health- Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital and Research Institute
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: