Using PSMA-PET imaging to find early metastatic prostate cancer in men with 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)
PHASE2; PHASE3 · H. Lee Moffitt Cancer Center and Research Institute · NCT03495427
This study is testing a new type of imaging to see if it can help find early signs of recurring prostate cancer in men with high-risk test scores.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT03495427 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of F-DCFPyL-PSMA PET imaging in detecting recurrent or metastatic prostate cancer in men who have previously participated in a related study and have high-risk Decipher test results. The study will enroll 60 patients who have undergone radical prostatectomy or radiation therapy and have a Decipher score greater than 0.45. Participants will receive an injection of F-DCFPyL followed by PET imaging to assess the extent of their disease. The goal is to improve the management of prostate cancer by better identifying patients with recurrent disease.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with high-risk Decipher test scores who have undergone radical prostatectomy or radiation therapy.
Not a fit: Patients who are unable to undergo PET imaging due to comorbidities or claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of recurrent metastatic prostate cancer in high-risk patients.
How similar studies have performed: While PSMA-PET imaging is used in some regions, this specific application in high-risk prostate cancer patients is relatively novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Kosj Yamoah, M.D., Ph.D. — H. Lee Moffitt Cancer Center and Research Institute
- Study coordinator: Riley Smith
- Email: Riley.Smith@moffitt.org
- Phone: 813-799-6821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Recurrent Prostate Cancer, radioactive diagnostic imaging