Status:
COMPLETED
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Lead Sponsor:
Francis Medical Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
45-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04087980
Start Date
April 10 2020
End Date
May 25 2022
Last Update
July 26 2022
Active Locations (5)
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1
Chesapeake Urology
Baltimore, Maryland, United States, 21204
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Minnesota Urology
Woodbury, Minnesota, United States, 55125
4
Bon Secours/Good Samaritan Hospital
New York, New York, United States, 10901