Testing Experimental PET/CT Imaging for High Risk Prostate Cancer

Inclusion Criteria

• Patients must have histologically proven prostate adenocarcinoma confirmed by a Clinical Laboratory Improvement Act (CLIA) certified laboratory
• Must have prostate cancer with high risk features defined as: * Gleason 8 and higher OR * Prostate specific antigen (PSA) > 20 ng/mL OR * Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
• Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Hemoglobin >= 9 g/dL
• Leukocytes >= 3,000/mcL
• Platelets >= 100,000/mcL
• Total bilirubin < 2 X normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X normal institutional limits
• Creatinine < 2 X normal institutional limits OR estimated glomerular filtration rate (eGFR) >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Ability of subject to understand and the willingness to sign a written informed consent document
• Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible
• Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

Exclusion Criteria

• Any investigational agents in the past 28 days prior to enrollment
• Clinical stage T4 (tumor invades adjacent structures except seminal vesicles)
• Distant metastatic disease on conventional imaging studies (computed tomography [CT] of the abdomen and pelvis and bone scan). Sodium fluoride (NaF) PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed
• Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as =< 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry
• Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy
• Contraindication to MRI or PET: * Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry * Prior reaction to 18F-DCFPyL * Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T * Severe claustrophobia unresponsive to oral anxiolytics
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy
• A malignancy within the past 3 years for which prostatectomy is a contraindication
• Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging
• PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with gallium
• Unable to refrain from fathering a child or donating sperm for 10 days after each 18F-DCFPyL injection