Prostate CancerVAPOR 2NCT05683691
Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
A study testing Vanquish System in people with Prostate Cancer, run by Francis Medical Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Vanquish System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 25 sitesUnited States
- Study dates
- 16 May 2023to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
- <15mm diameter of qualifying lesion as measure by greatest diameter
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- 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.
- Subject is willing and able to be treated within 180 days after signing consent.
Who cannot join
- 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.
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- 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
- Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use
- 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)
- 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.
- Active or clinically chronic prostatitis or granulomatous prostatitis
- Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
- Any previous treatment for prostate cancer.
- Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
- Unable to stop taking antiplatelet medications or other blood thinning agents
- Known allergy to nickel
- Allergic to medication required by the study such as MRI contrast or anesthesia
- Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
- 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
- Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
- Subject is considered vulnerable such as incarcerated or cognitively impaired.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Urology Austin
Austin, Texas, 78745
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Chesapeake Urology
Baltimore, Maryland, 21204
Johns Hopkins
Baltimore, Maryland, 21287
University of Chicago
Chicago, Illinois, 60637
The Urology Group
Cincinnati, Ohio, 45212
Duke Cancer Institute
Durham, North Carolina, 27710
Houston Methodist Hospital and Research Institute
Houston, Texas, 77030
Kasraeian Urology
Jacksonville, Florida, 32216
Memorial Care
Laguna Hills, California, 92653
University of Southern California
Los Angeles, California, 90089
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55454
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
NYU Langone Health
New York, New York, 10016
Northwell Health- Lenox Hill Hospital
New York, New York, 11222
Mayo Clinic- Phoenix
Phoenix, Arizona, 85054
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14620
Corewell Health / William Beaumont University Hospital
Royal Oak, Michigan, 48073
The Urology Place
San Antonio, Texas, 78240
Michigan Institute of Urology
Troy, Michigan, 48084
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Wichita Urology
Wichita, Kansas, 67226
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
Official title: Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
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.
- Conditions
- Prostate Cancer
- Being tested
- Vanquish System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanquish SystemDevice
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Vanquish System Treatment | Experimental | Not described Receives: Device: Vanquish System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Measured: 36 months
Primary Safety Endpoint
The proportion of subjects free from new or worsening urinary incontinence based on pad use at 12 months will be statistically compared to a performance goal.
Measured: 12 months
Secondary outcomes (1)
Key Secondary Endpoint
The proportion of subjects free from impotence.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start16 May 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Multicenter, Single-Arm Study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francis Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683691
- Sponsor's protocol ID
- 4760-001
- Acronym
- VAPOR 2
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
- ClinicalTrials.gov ID
- NCT05683691
- Acronym / sponsor ID
- VAPOR 2 / 4760-001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Francis Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Multicenter, Single-Arm Study
| Arm | Type | Receives |
|---|---|---|
| Vanquish System Treatment | Experimental | Device: Vanquish System |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vanquish SystemWater vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer. | Device | Vanquish System Treatment |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 36 months
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Primary Safety Endpoint
Time frame: 12 months
The proportion of subjects free from new or worsening urinary incontinence based on pad use at 12 months will be statistically compared to a performance goal.
1 secondary outcome
Key Secondary Endpoint
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanquish System in people with Prostate Cancer, run by Francis Medical Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.