Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer

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    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 20 October 2022


This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.


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.

Condition Advanced Prostate Cancer
Treatment Pelvic DCFPyL PET-MRI fusion or PET/MRI
Clinical Study IdentifierNCT02420977
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on20 October 2022


Yes No Not Sure

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
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