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

July 25, 2022 updated by: Francis Medical Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serious device related adverse events
Time Frame: 180-day follow-up
180-day follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled
Time Frame: Up to 1 Years
Up to 1 Years
Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)
Time Frame: 180-day follow-up
180-day follow-up
Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)
Time Frame: 180-day follow-up
180-day follow-up
Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)
Time Frame: 180-day follow-up
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
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
180-day follow-up
Participants evaluated for biopsy negative on the treated side
Time Frame: 180-day follow-up
180-day follow-up
Changes from baseline with the PSA (Prostate Specific Antigen)
Time Frame: Up to 1 Year
Up to 1 Year
Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)
Time Frame: 180-day follow-up
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
180-day follow-up
Participants evaluated for biopsy negative on the contralateral side
Time Frame: 180-day follow-up
180-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Francis Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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