search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Poseidon System
Sponsored by
Francis Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Chesapeake Urology
  • University of Minnesota
  • Minnesota Urology
  • Bon Secours/Good Samaritan Hospital
  • Urology San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Poseidon System Treatment

Arm Description

Outcomes

Primary Outcome Measures

Serious device related adverse events

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2019
Last Updated
July 25, 2022
Sponsor
Francis Medical Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04087980
Brief Title
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Francis Medical Inc.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chesapeake Urology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Minnesota Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Bon Secours/Good Samaritan Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10901
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs