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The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipherae Test Scores A Sub-aim of the VANDAAM Study MCC 18523
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02
60
Participants Needed
1
Research Sites
12 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 research focuses on men with prostate cancer who previously participated in a study called VANDAAM and had high-risk Decipher test results indicating a high genomic classifier GC score. The study aims to evaluate the safety and usefulness of a new imaging method called F-DCFPyL Prostate-specific Membrane Antigen PSMA Positron Emission Tomography PET in detecting recurrent or metastatic prostate cancer. This imaging technique is not yet standard care but may improve how prostate cancer spread is identified and managed in the future. Participants will undergo F-DCFPyL PSMA PET imaging once a year for four years. Each imaging session involves receiving an injection of 9 b1 1 mCi of F-DCFPyL via a catheter placed in a vein. This radioactive diagnostic agent helps highlight cancer cells during the PET scan. The study includes men treated with surgery or radiation therapy at least two years prior and follows their imaging results over time. During the study, researchers will monitor the concordance between high tumor genomic risk scores and positive PSMA-PET imaging findings for up to five years. They will also track the rate of positive PSMA-PET results over this period. Participants health is assessed with performance status evaluations, and the imaging is done annually. The total participation involves multiple annual imaging visits and follow-up evaluations to better understand the imaging tests value in detecting early metastatic prostate cancer.
CONDITIONS
Brief 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 with high-risk Decipher score (>0.45)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Genomic classifier testing completed on biopsy or surgical specimen
- Treated with radical prostatectomy or radiation therapy, with or without short-term androgen deprivation therapy, and at least 2 years of follow-up
- 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 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 within 5 days before study drug injection (oral water contrast is allowed)
Research Team
R
Riley Smith
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