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

RecruitingPhase 2, Phase 3Ages 18 Years - anyMaleH. Lee Moffitt Cancer Center and Research Institu…
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • F-DCFPyL Injection
  • PSMA PET
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Where

1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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