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



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:7/14/2018
Start Date:May 2015
End Date:November 2019

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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)
We found this trial at
1
site
Baltimore, Maryland 21287
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from
Baltimore, MD
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