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

Francis Medical Inc.26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Poseidon System

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

Chesapeake Urology

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Minnesota Urology

Woodbury, Minnesota, United States

Bon Secours/Good Samaritan Hospital

New York, New York, United States

Urology San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Serious device related adverse events

Time frame: 180-day follow-up

Secondary Outcomes

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