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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)

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? F-DCFPyL Injection+Prostate-Specific Membrane Antigen PET
Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
Florida
H. Lee Moffitt Cancer Center and Research Institute
RECRUITING
Tampa
Contact Information
Primary
Riley Smith
Riley.Smith@moffitt.org
813-799-6821
Time Frame
Start Date: 2019-12-18
Estimated Completion Date: 2029-05
Participants
Target number of participants: 60
Treatments
Experimental: Radioactive Diagnostic Imaging
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
Related Therapeutic Areas
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Progenics Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov