Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Inclusion Criteria:

• Age ≥18 years
• History of adenocarcinoma of the prostate treated with radical prostatectomy
• Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
• Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion Criteria:

• Intention to enroll in a blinded therapeutic clinical trial
• History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)