Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

The investigators propose to evaluate the feasibility of using a novel small molecule PET
radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA
is a well studied cell surface marker of prostate cancer with increased expression associated
with higher tumor grade and advanced metastatic tumors. More specifically it is associated
with a higher Gleason score and there is evidence it can serve as a potential marker for
prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT
response. This small molecule PET radiotracer specifically targeting an important prostate
specific marker of AR signaling dynamics following ADT, tumor progression and metastatic
potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA
expression and prostate cancer detection.

Inclusion Criteria:

- Men 18 years of age or greater with recently diagnosed prostate cancer with planned
radiation and ADT.

- Key inclusion criteria (the entire list of inclusion and exclusion criteria will
appear later in section 4 of the protocol)

- Newly diagnosed prostate cancer pathologically proven by prostate biopsy

- Prostate biopsy histology grade ≥ Gleason 8-10

- Patients considered as candidates for and medically fit to undergo radiation and
ADT

- At least 10 days after most recent prostate biopsy

Exclusion Criteria:

- Prior pelvic external beam radiation therapy or brachytherapy

- Chemotherapy for prostate cancer

- Hormone deprivation therapy

- Investigational therapy for prostate cancer

- Hemorrhagic cystitis or active prostatitis