Actively Recruiting
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02
60
Participants Needed
1
Research Sites
488 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
Progenics Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
CONDITIONS
Official Title
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously enrolled in MCC#18523 VANDAAM study
- High-risk Decipher test score above 0.45
- ECOG performance status of 0 or 1
- Completed genomic classifier testing on biopsy or surgical specimen
- Treated with radical prostatectomy or radiation therapy with or without short-term androgen deprivation therapy
- At least 2 years of follow-up post-treatment
- Male aged 18 years or older
You will not qualify if you...
- No follow-up information available after treatment
- Unable to undergo PET imaging due to other health conditions or claustrophobia
- Received any radioisotope within 5 physical half-lives before study drug injection
- Received any intravenous X-ray contrast medium within 24 hours before study drug injection
- Received any high-density oral contrast medium (except oral water) within 5 days before study drug injection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Riley Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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