18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.

Inclusion Criteria:

• Histologically confirmed diagnosis of prostate cancer
• Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)
• Age ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Ability to understand and willingness to sign a written informed consent document
• Willing 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 unless approved by the PI
• Administration of another radioisotope within five physical half-lives of trial enrollment
• Radiation or chemotherapy within 2 weeks prior to trial enrollment
• Estimated glomerular filtration rate (eGFR) < 15 ml/mmol
• Serum total bilirubin > 3 times the upper limit of normal
• Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal
• Inadequate venous access
• Claustrophobia or any other condition that would preclude PET imaging
• Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.
• Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC