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

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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Poseidon System

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Urology
  • New York
    • New York, New York, United States, 10901
      • Bon Secours/Good Samaritan Hospital
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serious device related adverse events	180-day follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Francis Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): April 13, 2021
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: VAPOR I Pilot Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes