Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04087980 |
Recruitment Status :
Completed
First Posted : September 12, 2019
Last Update Posted : July 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Device: Poseidon System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 10, 2020 |
Actual Primary Completion Date : | April 13, 2021 |
Actual Study Completion Date : | May 25, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Poseidon System Treatment |
Device: 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 |
- Serious device related adverse events [ Time Frame: 180-day follow-up ]
- 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 ]

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087980
United States, Maryland | |
Chesapeake Urology | |
Baltimore, Maryland, United States, 21204 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
Minnesota Urology | |
Woodbury, Minnesota, United States, 55125 | |
United States, New York | |
Bon Secours/Good Samaritan Hospital | |
New York, New York, United States, 10901 | |
United States, Texas | |
Urology San Antonio | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | Francis Medical Inc. |
ClinicalTrials.gov Identifier: | NCT04087980 |
Other Study ID Numbers: |
VAPOR I Pilot Study |
First Posted: | September 12, 2019 Key Record Dates |
Last Update Posted: | July 26, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |