What this study is
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.
What's being tested
- F-DCFPyL Injection
Intervention · DRUG
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
- PSMA PET
Intervention · DIAGNOSTIC TEST
PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
Study details
- Official title
- The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Prostate Cancer · Recurrent Prostate Cancer
- Enrolling
- 60 people
- Starts
- 2019-12-18
- Est. completion
- 2029-05
- Design
- Open-label, single group, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Previously enrolled to MCC#18523
- Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
- Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
- Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
- Age > 18
You can't join if
- No follow up information available post treatment
- Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
- Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openH. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
- Kosj Yamoah, M.D., Ph.D. · Principal investigator
- Kenneth Gage, M.D., Ph.D. · Principal investigator
Recruiting
Study team
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID MCC-19291
Principal investigator
Kosj Yamoah, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.