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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087980
• Other study ID #: VAPOR I Pilot Study
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: March 2022
• Source: Francis Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 25, 2022
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Chesapeake Urology	Baltimore	Maryland
United States	University of Minnesota	Minneapolis	Minnesota
United States	Bon Secours/Good Samaritan Hospital	New York	New York
United States	Urology San Antonio	San Antonio	Texas
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Francis Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious device related adverse events		180-day follow-up
Secondary	Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled		Up to 1 Years
Secondary	Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)		180-day follow-up
Secondary	Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)		180-day follow-up
Secondary	Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)		180-day follow-up
Secondary	Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)		180-day follow-up
Secondary	Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy		180-day follow-up
Secondary	Participants evaluated for biopsy negative on the treated side		180-day follow-up
Secondary	Changes from baseline with the PSA (Prostate Specific Antigen)		Up to 1 Year
Secondary	Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)		180-day follow-up
Secondary	Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy		180-day follow-up
Secondary	Participants evaluated for biopsy negative on the contralateral side		180-day follow-up