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Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer

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
Sponsor:
Information provided by (Responsible Party):
Francis Medical Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Poseidon System Not Applicable

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Serious device related adverse events [ Time Frame: 180-day follow-up ]

Secondary Outcome Measures :
  1. Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled [ Time Frame: Up to 1 Years ]
  2. Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC) [ Time Frame: 180-day follow-up ]
  3. Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF) [ Time Frame: 180-day follow-up ]
  4. Changes from baseline in the International Prostate Cancer Symptom Score (IPSS) [ Time Frame: 180-day follow-up ]
  5. Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD) [ Time Frame: 180-day follow-up ]
  6. Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy [ Time Frame: 180-day follow-up ]
  7. Participants evaluated for biopsy negative on the treated side [ Time Frame: 180-day follow-up ]
  8. Changes from baseline with the PSA (Prostate Specific Antigen) [ Time Frame: Up to 1 Year ]
  9. Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging) [ Time Frame: 180-day follow-up ]
  10. Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy [ Time Frame: 180-day follow-up ]
  11. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Francis Medical Inc.
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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

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases