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Ablation of Prostate Tissue in Patients With Intermediate Risk Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087980
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Francis Medical Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Poseidon System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue in Patients With Intermediate Risk Localized Prostate Cancer
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Poseidon System Treatment Device: Poseidon System
Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue in Patients with Intermediate Risk Localized Prostate Cancer


Outcome Measures
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Primary Outcome Measures :
  1. Serious device related adverse events [ Time Frame: 180-day follow-up ]

Secondary Outcome Measures :
  1. Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled [ Time Frame: Up to 5 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 of the PI-RADS (Prostate Imaging - Reporting and Data System) Score by characterizing the effect of the ablation on the treated side from MRI (Magnetic Resonance Imaging) [ Time Frame: 180-day follow-up ]
  9. Changes from baseline with the PSA (Prostate Specific Antigen) [ Time Frame: 180-day and through study completion, an average of 5 years ]
  10. Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging) [ Time Frame: 180-day follow-up ]
  11. Evaluating the target tissue being ablated via MRI (Magnetic Resonance Imaging) [ Time Frame: 7-day follow-up ]
  12. Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy [ Time Frame: through study completion, an average of 5 years ]
  13. Participants evaluated for biopsy negative on the contralateral side [ Time Frame: through study completion, an average of 5 years ]
  14. Number of retreatments with the Poseidon System [ Time Frame: through study completion, an average of 5 years ]
  15. Time to curative treatment, in particular, radical prostatectomy or radiotherapy [ Time Frame: through study completion, an average of 5 years ]
  16. Disease specific survival defined as time to death due to underlying disease [ Time Frame: through study completion, an average of 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 45-80 years old
  • MRI/TRUS (Magnetic Resonance Imaging/Transrectal Ultrasound) Fusion biopsy confirmed unilateral, adenocarcinoma of the prostate
  • 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 or external urethral sphincter
  • Narrow Peripheral Zone
  • Positive Bone Scan for Cancer
  • Prior definitive treatment of prostate cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087980


Contacts
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Contact: Rachael Krzmarzick 763-706-5997 rkrzmarzick@francismedical.com

Sponsors and Collaborators
Francis Medical Inc.
More Information
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Responsible Party: Francis Medical Inc.
ClinicalTrials.gov Identifier: NCT04087980    
Other Study ID Numbers: VAPOR I Pilot Study
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases