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Recruiting Phase 2 / Phase 3

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

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About this study

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.

Condition
Prostate Cancer, Recurrent Prostate Cancer
Tested
F-DCFPyL Injection, PSMA PET
Sponsor
H. Lee Moffitt Cancer Center and Research Institute

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer, Recurrent Prostate Cancer
  • 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 3

  • 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

1 site, 1 recruiting

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.