Prostate CancerNCT04087980
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
A study testing Poseidon System in people with Prostate Cancer, run by Francis Medical Inc. at 5 sites in United States.
Trial summary
The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Poseidon System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Apr 2020to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-80 years old
- Biopsy confirmed unilateral, adenocarcinoma of the prostate
- Minimum of 12 biopsy cores obtained ≥4 weeks and ≤12 months before treatment. Targeted fusion biopsy is preferred if there is a MRI PI-RADs ≥3 lesion. It is preferred a standard 12 sector biopsy is mapped. MRI required if biopsy was completed >6 months prior to treatment date to confirm no MRI progression of disease that would be considered exclusionary.
- ≤4 of 6 standard sector biopsy cores positive for prostate cancer (unilateral); positive core(s) from a targeted lesion count as one positive core.
- Gleason score of 7 (3+4) / International Society of Urological Pathologists (ISUP) Gleason Grade Group (GGG) 2
- Clinical Stage less than or equal to T2b N0 M0
- PSA (Prostate Specific Antigen) less than or equal to 15ng/mL
- Prostate size 20-80cc
Who cannot join
- Malignant tumors identified by extraprostatic extension, sphincter involvement/lesion abutment seminal vesicle invasion or lymph node invasion or metastasis
- Narrow Peripheral Zone
- MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma
- Prior definitive treatment of prostate cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chesapeake Urology
Baltimore, Maryland, 21204
University of Minnesota
Minneapolis, Minnesota, 55455
Bon Secours/Good Samaritan Hospital
New York, New York, 10901
Urology San Antonio
San Antonio, Texas, 78229
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
Official title: Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.
- Conditions
- Prostate Cancer
- Being tested
- Poseidon 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.
Poseidon SystemDevice
Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients with Intermediate Risk Localized Prostate Cancer
| Study group | Role | What they receive |
|---|---|---|
| Poseidon System Treatment | Experimental | Not described Receives: Device: Poseidon System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious device related adverse events
Measured: 180-day follow-up
Secondary outcomes (11)
Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled
Measured: Up to 1 Years
Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)
Measured: 180-day follow-up
Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)
Measured: 180-day follow-up
Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)
Measured: 180-day follow-up
Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)
Measured: 180-day follow-up
Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy
Measured: 180-day follow-up
Participants evaluated for biopsy negative on the treated side
Measured: 180-day follow-up
Changes from baseline with the PSA (Prostate Specific Antigen)
Measured: Up to 1 Year
Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)
Measured: 180-day follow-up
Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy
Measured: 180-day follow-up
Participants evaluated for biopsy negative on the contralateral side
Measured: 180-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start10 Apr 2020
- Primary completion13 Apr 2021
- Study completion25 May 2022
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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francis Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087980
- Sponsor's protocol ID
- VAPOR I Pilot Study
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04087980
- Acronym / sponsor ID
- VAPOR I Pilot Study
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Francis Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 12 Sep 2019 (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 research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poseidon System Treatment | Experimental | Device: Poseidon System |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 45-80 years old
- Biopsy confirmed unilateral, adenocarcinoma of the prostate
- Minimum of 12 biopsy cores obtained ≥4 weeks and ≤12 months before treatment. Targeted fusion biopsy is preferred if there is a MRI PI-RADs ≥3 lesion. It is preferred a standard 12 sector biopsy is mapped. MRI required if biopsy was completed >6 months prior to treatment date to confirm no MRI progression of disease that would be considered exclusionary.
- ≤4 of 6 standard sector biopsy cores positive for prostate cancer (unilateral); positive core(s) from a targeted lesion count as one positive core.
- Gleason score of 7 (3+4) / International Society of Urological Pathologists (ISUP) Gleason Grade Group (GGG) 2
Key exclusion criteria (4 listed)
- Malignant tumors identified by extraprostatic extension, sphincter involvement/lesion abutment seminal vesicle invasion or lymph node invasion or metastasis
- Narrow Peripheral Zone
- MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma
- Prior definitive treatment of prostate cancer
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 |
|---|---|---|
| Poseidon SystemMulticenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients with Intermediate Risk Localized Prostate Cancer | Device | Poseidon System Treatment |
Primary outcome
Serious device related adverse events
Time frame: 180-day follow-up
11 secondary outcomes
Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled
Time frame: Up to 1 Years
Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)
Time frame: 180-day follow-up
Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)
Time frame: 180-day follow-up
Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)
Time frame: 180-day follow-up
Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)
Time frame: 180-day follow-up
Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy
Time frame: 180-day follow-up
Participants evaluated for biopsy negative on the treated side
Time frame: 180-day follow-up
Changes from baseline with the PSA (Prostate Specific Antigen)
Time frame: Up to 1 Year
Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)
Time frame: 180-day follow-up
Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy
Time frame: 180-day follow-up
Participants evaluated for biopsy negative on the contralateral side
Time frame: 180-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poseidon System in people with Prostate Cancer, run by Francis Medical Inc. at 5 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious device related adverse events (time frame: 180-day follow-up). 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 26 Jul 2022.