Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
Primary Objective:

 -  To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after
 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with
 radiographic progression free survival (rPFS) as defined by Prostate Cancer Working
 Group 3 (PCWG3) criteria.

 Secondary Objectives:

 -  To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with
 overall survival (OS)

 -  To determine whether baseline SUVmax correlate with rPFS

 -  To compare number of lesions detected with standard imaging at baseline and at the time
 of progression
Prostate cancer is the most common cancer and the third most common cause of cancer deaths in
 American men. The lethal form of the disease is metastatic castrate resistant prostate cancer
 (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a
 marker of disease and is commonly used in the community to guide therapy.

 PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane
 antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary
 studies it demonstrates a higher detection of metastatic prostate lesions compared to
 standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been
 evaluated, specifically the potential to serve as a predictive biomarker of response. Given
 the high cost of current therapeutic agents in mCRPC, there is a need for an early response
 biomarker to stratify which patients will benefit from therapy and which will not. This will
 also allow for earlier change in management of patients who will not response to these
 therapies, potentially improving patient outcomes.
Inclusion Criteria:

 -  Histologically confirmed diagnosis of prostate cancer

 -  Age ≥ 18 years of age

 -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

 -  Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working
 Group 3

 -  Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel,
 cabazitaxel) for their disease

 -  Ability to understand and willingness to sign a written informed consent document

 -  Wiling to comply with clinical trial instructions and requirements

 Exclusion Criteria:

 -  History of another active malignancy within 3 years, other than basal cell and
 squamous cell carcinoma of the skin

 -  Presence of prostate brachytherapy implants

 -  Administration of another radioisotope within five physical half-lives of trial
 enrollment

 -  Radiation or chemotherapy within 2 weeks prior to trial enrollment

 -  Serum creatinine > 3 times the upper limit of normal

 -  Serum total bilirubin > 3 times the upper limit of normal

 -  Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper
 limit of normal

 -  Inadequate venous access