Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
NCT ID: NCT04087980
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2020-04-10
2022-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Poseidon System Treatment
Poseidon System
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
Interventions
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Poseidon System
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Narrow Peripheral Zone
* MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma
* Prior definitive treatment of prostate cancer
45 Years
80 Years
MALE
No
Sponsors
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Francis Medical Inc.
INDUSTRY
Responsible Party
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Locations
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Chesapeake Urology
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Minnesota Urology
Woodbury, Minnesota, United States
Bon Secours/Good Samaritan Hospital
New York, New York, United States
Urology San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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VAPOR I Pilot Study
Identifier Type: -
Identifier Source: org_study_id
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