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 PSA.
• PSA density ≤0.15
• ≥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 PSMA PET scan.
• Within 6 months prior to signing consent have had a multiparametric MRI.
• mpMRI results must show localized disease meaning a single MRI region of suspicion (PI-RADS ≥3 with lesion volume ≤1.5 cc).
• Maximum lesion diameter in any MRI dimension must be ≤11.9 mm.
• Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal)
• Central Pathology confirmation showing a minimum of 2 cores in aggregate of pattern 4 disease (GG3) in the targeted lesion identified by Central Imaging
• GG1 cores from anywhere in the prostate are acceptable
• Less than 50% of systematic biopsy cores are positive for GGG 1 or 2 disease. For the \<50% calculation, all systematic positive cores located in the sector(s) containing the target, or in sectors immediately adjacent to the qualifying target, are counted as "one core."
• Within 6 months prior to signing consent have had a PSMA-PET scan.
• PSMA-PET results show no suspicion of metastasis as determined by site read
• Per Radiology Central Imaging, PSMA-PET scan prostate results are concordant with mpMRI results

You may not qualify if:

• 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 (LHRH) agonists or antagonists within the past 12 months,
• or Testosterone supplementation (3-month washout required) A participant on BPH 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 questionnaires.
• Participant currently participating in other prostate tissue and/or cancer study unless approved by Sponsor in writing.
• Participant is considered vulnerable such as incarcerated or cognitively impaired.

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: July 31, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share