Active — Not RecruitingNot Applicable

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

United States400 participantsStarted 2023-05-16

Plain-language 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.

Who can participate

Age range50 Years

SexMALE

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Inclusion criteria

✓. ≥50 years of age; with life expectancy of ≥10 years
✓. 20-80 cc prostate size determined by MRI Central Imaging
✓. ≤15 ng/ml PSA
✓. Cancer stage less than or equal to T2c
✓. 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.
✓. Subject is willing and able to adhere to specific protocol visits and required testing throughout study
✓. 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
✓. Able and willing to provide written consent to participate in the study.

Exclusion criteria

✕. Patients with \>GGG3 cores anywhere in the prostate
✕. MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE)
✕. All MRI Central Imaging confirmed PI-RADS 5 lesions
✕. All MRI Central Imaging confirmed additional PI-RADS 4 lesions.
✕. Contraindications to MRI
✕. 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.
✕. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
✕. Treated within the past 5 years for genital cancer

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 36 months

Primary Safety Endpoint

Timeframe: 12 months

Trial details

NCT IDNCT05683691

SponsorFrancis Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

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