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

Sponsor

Francis Medical Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04087980

Collaborator

(none)

Enrollment

Locations

Arm

25.5

Actual Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 10, 2020

Actual Primary Completion Date :

Apr 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

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

Serious device related adverse events [180-day follow-up]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Chesapeake Urology	Baltimore	Maryland	United States	21204
2	University of Minnesota	Minneapolis	Minnesota	United States	55455
3	Minnesota Urology	Woodbury	Minnesota	United States	55125
4	Bon Secours/Good Samaritan Hospital	New York	New York	United States	10901
5	Urology San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Francis Medical Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francis Medical Inc.

ClinicalTrials.gov Identifier:

NCT04087980

Other Study ID Numbers:

VAPOR I Pilot Study

First Posted:

Sep 12, 2019

Last Update Posted:

Jul 26, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jul 26, 2022