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NCT Number: NCT04087980

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chesapeake Urology, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poseidon System

Device

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 outcomes

  1. Serious device related adverse events

    Time frame: 180-day follow-up

Secondary outcomes

  1. Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled

    Time frame: Up to 1 Years

  2. Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)

    Time frame: 180-day follow-up

  3. Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)

    Time frame: 180-day follow-up

  4. Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)

    Time frame: 180-day follow-up

  5. Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)

    Time frame: 180-day follow-up

  6. Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy

    Time frame: 180-day follow-up

  7. Participants evaluated for biopsy negative on the treated side

    Time frame: 180-day follow-up

  8. Changes from baseline with the PSA (Prostate Specific Antigen)

    Time frame: Up to 1 Year

  9. Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)

    Time frame: 180-day follow-up

  10. Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy

    Time frame: 180-day follow-up

  11. Participants evaluated for biopsy negative on the contralateral side

    Time frame: 180-day follow-up

Sponsors and collaborators

Lead sponsor

Francis Medical Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 12, 2019
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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