NCT03495427RecruitingPhase 2/3
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)
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Apr 2018
- Start date
- 18 Dec 2019
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT03495427
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- From 18 Dec 2019 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- No follow up information available post treatment
- Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.