Prostate Cancer Clinical Trial
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk 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.
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
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
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There is 1 Location for this study
Pittsburgh Pennsylvania, 15232, United States
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