Water Vapor Ablation for Grade Group 3 Prostate Cancer

NCT07652164 | Not Yet Recruiting FDA Device

• 1 other identifier: 5700-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation System ("Vanquish") in participants with Grade Group 3 (GG3) intermediate-risk prostate cancer. Participants will undergo therapy with the Vanquish System and complete follow up visits at 7 days, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Conditions

Prostate Cancer

Keywords

Vapor; Ablation; Prostate Cancer; Grade Group 3; Water Vapor

Outcome Measures

Primary Outcomes (2)

• Ablative Efficacy 6-Months Post Ablation

  Ablative efficacy after one or two ablations indicating \<GG2 cancer in the region of the prostate targeted for Vanquish therapy and evaluated at 6 months post ablation.

  6 months post procedure.

• Rate of Serious Adverse Events Through 6-Months

  Rate of serious adverse events through 6-months classified per Clavien-Dindo and assessed as related to the Vanquish procedure and/or device. Clavien-Dindo Classifications * Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment, surgical, endoscopic, or radiological interventions. * Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I complications. * Grade III: Complications requiring surgical intervention (IIIa: laparoscopic, IIIb: open). * Grade IV: Life-threatening complications (IVa: single organ failure, IVb: multi-organ failure). * Grade V: Death of a patient.

  From the start of the Vanquish procedure through 6-months post procedure.

Secondary Outcomes (1)

• Rate of Serious Adverse Events Through 24-Months

  From the start of the Vanquish procedure through 24-months post procedure.

Study Arms (1)

Vanquish System Therapy

EXPERIMENTAL

Device: Water Vapor Ablation

Interventions

Water Vapor Ablation DEVICE

Water vapor ablation delivered transurethrally in patients with Grade Group 3 (GG3) intermediate risk prostate cancer.

Also known as: Vanquish System Therapy

Vanquish System Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has been diagnosed with Grade Group 3 (GG3) intermediate-risk prostate cancer.
• ≤20 ng/ml prostate specific antigen (PSA).
• Prostate volume of 20-80cc per Central Imaging read.
• ≥50 years of age; with life expectancy of ≥10 years.
• Clinical cancer stage less than or equal to T2c (tumor may involve both sides of the prostate but without evidence that tumor extends outside of the prostate and with no cancer cells found in nearby lymph nodes) evaluated by prostate specific membrane antigen positron emission tomography (PSMA PET) scan.
• Within 6 months prior to signing consent have had a multiparametric MRI (mpMRI).
• a.) mpMRI results must show localized disease meaning a single MRI region of suspicion (PI-RADS lesion volume ≤2.25cc with a maximum lesion diameter \<17mm as measured by diffusion weighted imaging (DWI) determined by Central Imaging).
• Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal).
• Minimum of 2 targeted cores from a single ROI identified by Central Imaging review, and at least one core confirming GG3 disease on biopsy (lesion may cross the midline); Gleason Grade Group determined by highest Gleason score of the targeted core.
• GG1 cores from anywhere in the prostate are acceptable.
• Less than 50% of systematic biopsy cores are positive for GG1 disease. For the \<50% calculation, all positive cores located in the target, are counted as "one core."
• All positive GG2 or GG3 cores must be located in the lesion, or immediately adjacent to the lesion, as determined by the fusion system's tracking, mapping and imaging documentation features.
• Additional MRI regions of suspicion that are Central Imaging confirmed PI-RADS ≤3 that are negative on biopsy or GG1 are acceptable.
• Within 6 months prior to signing consent have had a PSMA-PET scan.
• PSMA-PET scan results show no suspicion of metastasis as determined by site read.

You may not qualify if:

• MRI evidence of extracapsular extension of cancer (MRI read as capsular invasion, bulge, or frank ECE) as determined by Central Imaging.
• Any additional Central Imaging confirmed PI-RADS 4 or 5 suspicious lesions.
• Participants with ≥GG4 cores anywhere in the prostate.
• Participants with GG2 or GG3 cores outside the region of interest.
• Contraindications per the Vanquish Instructions for Use.
• Any previous treatment for prostate cancer or any prior surgery, intervention, or minimally invasive therapy (MIST) for the prostate or bladder neck, including but not limited to Vanquish therapy, TUIP, TURP, Aquablation, Green Light, Rezūm, Prostatic Urethral Lift, iTind, Prostatic Arterial Embolization, or microwave therapy.
• Currently taking medications that have hormonal effects on the prostate or PSA, such as:
• alpha reductase inhibitors, if on for \< 6 months (6-month washout required if participant is able and willing to stop medication),
• Androgen blockers,
• Luteinizing hormone-releasing hormone agonists or antagonists within the past 12 months,
• or Testosterone supplementation, if on for \< 3 months (3-month washout required if participant is able and willing to stop medication)
• A participant on benign prostatic hyperplasia medication which does not affect the PSA can be included.
• Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
• 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 (QOL) questionnaires.
• Participant currently participating in other prostate tissue and/or cancer study unless approved by Sponsor in writing.

Sponsors & Collaborators

• Francis Medical Inc.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Rachael Krzmarzick

CONTACT

763-607-5997; rkrzmarzick@francismedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multicenter, Single-Arm Study

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share