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

• ClinicalTrials.gov Identifier: NCT04087980
• Recruitment Status: Completed
• First Posted: September 12, 2019
• Last Update Posted: July 26, 2022
• Sponsor: Francis Medical Inc.
• Information provided by (Responsible Party): Francis Medical Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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.

More Information

• Responsible Party: Francis Medical Inc.
• ClinicalTrials.gov Identifier: NCT04087980
• Other Study ID Numbers: VAPOR I Pilot Study
• First Posted: September 12, 2019
• 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

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases