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

Normally, some patients with prostate cancer undergo imaging tests to determine the extent
(spread) of their disease. These imaging tests often give good information, but not in all
patients and not every time. This study deals with a new imaging test known as
F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or
F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using
F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging
technique is used in some parts of the world but is not currently standard imaging care.
Better understanding how this new imaging test performs in identifying recurrent/metastatic
prostate cancer may lead to better management of prostate cancer patients in the future.

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

- Normal renal function defined as serum creatinine of ≤ 1.5 X upper limit of normal
(ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula). Male
creatinine clearance = (140 - age in years) x weight in kg x 1.0072 x serum creatinine
in mg/dL

- 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