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NCT07652164
Water Vapor Ablation for Grade Group 3 Prostate Cancer
Conditions: Prostate Cancer
Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Francis Medical Inc.
Summary
The goal of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation System ("Vanquish") in participants with Grade Group 3 (GG3) intermediate-risk prostate cancer.
Participants will undergo therapy with the Vanquish System and complete follow up visits at 7 days, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Eligibility Criteria
Inclusion Criteria:
* Participant has been diagnosed with Grade Group 3 (GG3) intermediate-risk prostate cancer.
* ≤20 ng/ml prostate specific antigen (PSA).
* Prostate volume of 20-80cc per Central Imaging read.
* ≥50 years of age; with life expectancy of ≥10 years.
* Clinical cancer stage less than or equal to T2c (tumor may involve both sides of the prostate but without evidence that tumor extends outside of the prostate and with no cancer cells found in nearby lymph nodes) evaluated by prostate specific membrane antigen positron emission tomography (PSMA PET) scan.
* Within 6 months prior to signing consent have had a multiparametric MRI (mpMRI).
a.) mpMRI results must show localized disease meaning a single MRI region of suspicion (PI-RADS lesion volume ≤2.25cc with a maximum lesion diameter \
Source: ClinicalTrials.gov (NCT07652164). StuddyBuddy aggregates publicly available trial information.