PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
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)
About This Trial
- This study is testing whether an advanced body scan can detect early signs of prostate cancer spreading to other areas.
- It is designed for men who completed surgery or radiation at least two years ago and had a tumor test showing a higher risk of the cancer returning.
- To be eligible, patients must have already taken part in a specific earlier study evaluating these test results.
- Before considering this trial, you should know that it involves an imaging scan, so it may not be suitable for anyone who experiences severe claustrophobia or cannot lie still in a scanner.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether an advanced body scan can detect early signs of prostate cancer spreading to other areas.
Study Details
- Start Date: December 18, 2019
- Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Full Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Treatments
- Drug: F-DCFPyL Injection
- Diagnostic Test: PSMA PET