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

Francis Medical

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Vanquish System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05683691

4760-001

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Vanquish System Treatment

Experimental group

Treatment:

Device: Vanquish System