Prostate CancerVAPOR-LTRNCT07455058
Water Vapor Ablation for Prostate Cancer: Long-Term Registry
An observational study of Prostate Cancer, run by Francis Medical Inc. at 4 sites in United States.
Trial summary
The purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Vanquish Therapy
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jun 2026to 31 Jul 2041
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be enrolled based on the inclusion/exclusion criteria listed. The Investigator(s) are responsible for determining if a patient is a candidate for therapy with the Vanquish System.
Who may be able to join
- Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study.
- Participant is willing and able to provide written informed consent.
Who cannot join
- Contraindications per the Vanquish IFU
- Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
WK Advanced Urology Specialists
Bossier City, Louisiana, 71111
Ryan Wilkerson, 318-212-7335, rwilkerson@wkhs.com
Gerard Henry, MD
- Recruiting
The Urology Place, Inc.
San Antonio, Texas, 78240
Naveen Kella, MD, 210-617-3670, nkella@theupi.com
Naveen Kella, MD
- Recruiting
Urology of Virginia
Virginia Beach, Virginia, 23462
Robert Given, MD, 757-452-3461, rgiven@urologyofva.net
Robert Given, MD
- Recruiting
Minnesota Urology
Woodbury, Minnesota, 55125
Melissa Robb, 651-999-6800, mrobb@mnurology.com
Aaron Milbank, MD
About this study
Official title: Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry
The purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). This includes longitudinal assessment of patients who have received or will receive the therapy one or multiple times as part of routine clinical care and encompasses those who completed a company-sponsored Vanquish therapy study (as applicable).
- Conditions
- Prostate Cancer
- Being tested
- Vanquish Therapy
- 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 TherapyDevice
The Francis Medical, Inc. Vanquish Water Vapor Ablation Device ("Vanquish" or "Vanquish System") is a transurethral thermal water vapor ablation device. The Vanquish System is designed ablate prostate tissue, while minimizing side effects.
| Study group | Role | What they receive |
|---|---|---|
| Vanquish Procedure Patients | Patients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care. Receives: Device: Vanquish Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome
Freedom from disease specific mortality.
Measured: Through study completion, or up to 15 years.
Primary Safety Outcome
Rate of complications classified as Clavien-Dindo grades III-V and attributable to the Vanquish procedure and/or device over time.
- 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: Through study completion, or up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start5 Jun 2026
- Primary completion30 Apr 2041 (estimated)
- Study completion31 Jul 2041 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Francis Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455058
- Sponsor's protocol ID
- 5600-001
- Acronym
- VAPOR-LTR
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 18 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry
- ClinicalTrials.gov ID
- NCT07455058
- Acronym / sponsor ID
- VAPOR-LTR / 5600-001
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Francis Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 30 Apr 2041 (estimated)
- Study completion
- 31 Jul 2041 (estimated)
- First posted
- 6 Mar 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 purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). This includes longitudinal assessment of patients who have received or will receive the therapy one or multiple times as part of routine clinical care and encompasses those who completed a company-sponsored Vanquish therapy study (as applicable).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vanquish Procedure Patients | – | Device: Vanquish TherapyPatients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be enrolled based on the inclusion/exclusion criteria listed. The Investigator(s) are responsible for determining if a patient is a candidate for therapy with the Vanquish System.
Key inclusion criteria (2 listed)
- Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study.
- Participant is willing and able to provide written informed consent.
Key exclusion criteria (2 listed)
- Contraindications per the Vanquish IFU
- Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.
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 TherapyThe Francis Medical, Inc. Vanquish Water Vapor Ablation Device ("Vanquish" or "Vanquish System") is a transurethral thermal water vapor ablation device. The Vanquish System is designed ablate prostate tissue, while minimizing side effects. | Device | Vanquish Procedure Patients |
Primary outcome
Primary Efficacy Outcome
Time frame: Through study completion, or up to 15 years.
Freedom from disease specific mortality.
Primary Safety Outcome
Time frame: Through study completion, or up to 15 years
Rate of complications classified as Clavien-Dindo grades III-V and attributable to the Vanquish procedure and/or device over time. * 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.
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 18 Aug 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Francis Medical Inc. at 4 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Sydney Cartie (6122866855, scartie@francismedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Outcome (time frame: Through study completion, or up to 15 years.). 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 18 Aug 2026.