The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).
This is a one-arm single-stage prospective pilot study to determine how 18F-DCFPyL PSMA-PET/CT can be used as a diagnostic test before treatment with 177Lu-vipivotide tetraxetan, which is an approved therapy for advanced prostate cancer. The U.S. Food and Drug Administration (FDA) has approved 18F-DCFPyL as a diagnostic agent (radiotracer) option for prostate cancer, though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy. This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records. Participation in this research study is expected to last about 12 months. It is expected that about 30 people will take part in this research study. Progenics Pharmaceuticals, Inc. is funding this research study by providing funding and the imaging agent, 18F-DCFPyL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Fluorine-labeled small molecule, via intravenous infusion per protocol.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGBrigham and Womens Hospital
Boston, Massachusetts, United States
RECRUITINGProportion of Participants with PSMA-Positive Lesion
Defined as the number of participants with at least 1 PSMA-positive lesion on 18F-DCFPyL PSMA-PET.
Time frame: 1 Day
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