NCT04087980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

July 26, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

September 9, 2019

Last Update Submit

July 25, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Serious device related adverse events

    180-day follow-up

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

Poseidon System Treatment

EXPERIMENTAL
Device: Poseidon System

Interventions

Poseidon SystemDEVICE

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

Poseidon System Treatment

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Biopsy confirmed unilateral, adenocarcinoma of the prostate
  • ≤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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chesapeake Urology

Baltimore, Maryland, 21204, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

Bon Secours/Good Samaritan Hospital

New York, New York, 10901, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 12, 2019

Study Start

April 10, 2020

Primary Completion

April 13, 2021

Study Completion

May 25, 2022

Last Updated

July 26, 2022

Record last verified: 2022-03

Locations

US(5)