Clinical trial NCT04087980: Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Francis Medical Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 26
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serious device related adverse events
timeFrame: 180-day follow-up
Secondary outcomes:
measure: Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled
timeFrame: Up to 1 Years
measure: Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)
timeFrame: 180-day follow-up
measure: Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)
timeFrame: 180-day follow-up
measure: Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)
timeFrame: 180-day follow-up
measure: Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)
timeFrame: 180-day follow-up
measure: Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy
timeFrame: 180-day follow-up
measure: Participants evaluated for biopsy negative on the treated side
timeFrame: 180-day follow-up
measure: Changes from baseline with the PSA (Prostate Specific Antigen)
timeFrame: Up to 1 Year
measure: Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)
timeFrame: 180-day follow-up
measure: Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy
timeFrame: 180-day follow-up
measure: Participants evaluated for biopsy negative on the contralateral side
timeFrame: 180-day follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Chesapeake Urology
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: New York
country: United States
facility: Bon Secours/Good Samaritan Hospital
state: New York
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
References: