Prostate CancerVAPOR 3NCT07652164
Water Vapor Ablation for Grade Group 3 Prostate Cancer
A study testing Water Vapor Ablation in people with Prostate Cancer, run by Francis Medical Inc..
Trial 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. 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?
- Water Vapor Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to Sep 2028
- 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
- 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).
Show all 20Show fewer
- 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.
- Per Central Imaging, PSMA-PET scan prostate results are concordant with mpMRI results
- If PSMA-PET scan indicates an additional area of suspicion from the planned treatment area, a targeted repeat biopsy is required to rule out ≥ GG2.
- Participant is willing and able to adhere to specific protocol visits and required testing, including completion of all questionnaires, throughout study.
- Participant is geographically stable and near the site or able and willing to travel back to site for follow-up visits.
- Participant is able and willing to provide written consent to participate in the study.
Who cannot join
- 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.
Show all 16Show fewer
- 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 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.
- Participant is considered vulnerable, such as incarcerated or cognitively impaired.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vanquish® Water Vapor Ablation for Grade Group 3 PrOstate CanceR: A Multicenter Single Arm Study
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
- Being tested
- Water Vapor Ablation
- Keywords
- Vapor, Ablation, Prostate Cancer, Grade Group 3, Water Vapor
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Vapor AblationDevice
Also called Vanquish System Therapy
Water vapor ablation delivered transurethrally in patients with Grade Group 3 (GG3) intermediate risk prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Vanquish System Therapy | Experimental | Not described Receives: Device: Water Vapor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the start of the Vanquish procedure through 6-months post procedure.
Secondary outcomes (1)
Rate of Serious Adverse Events Through 24-Months
Rate of serious adverse events through 24-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.
Measured: From the start of the Vanquish procedure through 24-months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start31 Aug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (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
- 120 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
- NCT07652164
- Sponsor's protocol ID
- 5700-001
- Acronym
- VAPOR 3
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanquish® Water Vapor Ablation for Grade Group 3 PrOstate CanceR: A Multicenter Single Arm Study
- ClinicalTrials.gov ID
- NCT07652164
- Acronym / sponsor ID
- VAPOR 3 / 5700-001
- Conditions
- Prostate Cancer
- Keywords
- Vapor, Ablation, Prostate Cancer, Grade Group 3, Water Vapor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Francis Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Jun 2026 (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 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.
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 Therapy | Experimental | Device: Water Vapor Ablation |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Water Vapor AblationAlso: Vanquish System TherapyWater vapor ablation delivered transurethrally in patients with Grade Group 3 (GG3) intermediate risk prostate cancer. | Device | Vanquish System Therapy |
Primary outcome
Ablative Efficacy 6-Months Post Ablation
Time frame: 6 months post procedure.
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.
Rate of Serious Adverse Events Through 6-Months
Time frame: From the start of the Vanquish procedure through 6-months post procedure.
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.
1 secondary outcome
Rate of Serious Adverse Events Through 24-Months
Time frame: From the start of the Vanquish procedure through 24-months post procedure.
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 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Questions about this trial
What is this clinical trial studying?
A study testing Water Vapor Ablation in people with Prostate Cancer, run by Francis Medical Inc..
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 20 inclusion and 16 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Rachael Krzmarzick (763-607-5997, rkrzmarzick@francismedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablative Efficacy 6-Months Post Ablation (time frame: 6 months post procedure.). 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 11 Aug 2026.