← Back to Clinical Trials
Recruiting Phase 2, Phase 3 NCT03495427

NCT03495427 PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

◆ AI Clinical Summary
Plain-language summary for patients
Clinical Trial Summary
NCT ID NCT03495427
Status Recruiting
Phase Phase 2, Phase 3
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Condition Prostate Cancer
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2019-12-18
Primary Completion 2029-02

Trial Parameters

Condition Prostate Cancer
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 60
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2019-12-18
Completion 2029-02
Interventions
F-DCFPyL InjectionPSMA PET

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

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.

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

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology