This phase IV trial studies how well 18F-DCFPyL prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/ computed tomography (CT) imaging works to detect cancer in patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) and who are planned to receive standard of care 177Lu-vipivotide tetraxetan therapy. 18F-DCFPyL is a radioactive drug (tracer) that targets PSMA. PSMA is a protein found on the surface of most prostate cancer cells. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-DCFPyL. Because some cancers take up 18F-DCFPyL, it can be seen with PET. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. This trial evaluates whether 18F-DCFPyL PSMA PET/CT imaging works as well as standard of care imaging techniques (68Ga-PSMA-PET/CT) to detect cancer in patients with metastatic castrate-resistant prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06099093.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Heather Jacene
Phone: 617-632-3767
Brigham and Women's HospitalStatus: Active
Contact: Heather Jacene
Phone: 617-632-3767
PRIMARY OBJECTIVE:
I. To determine the proportion of patients who have at least 1 PSMA-positive lesion on fluorine F 18 piflufolastat (18F-DCFPyL) PSMA-PET.
EXPLORATORY OBJECTIVES:
I. To compare uptake in target lesions on single-photon emission computed tomography (SPECT)/CT after cycle 1 of lutetium Lu 177 vipivotide tetraxetan (177Lu-vipivotide tetraxetan) therapy between gallium Ga 68 gozetotide (68Ga-PSMA-11) and 18F-DCFPyL PSMA-PET.
II. To compare standardized uptake value (SUV)mean between 68Ga-PSMA-11 and 18F-DCFPyL at a patient level.
III. To explore SUVmean thresholds on 18F-DCFPyL PSMA-PET that are associated with a decrease in prostate-specific antigen (PSA) by >= 50% during 177Lu-vipivotide tetraxetan therapy.
IV. To explore use of artificial intelligence (AI) and machine learning (ML) tools in delineating tumor burden and volume on 18F-DCFPyL and 68Ga-PSMA-11 PSMA-PET.
OUTLINE:
Patients receive 18F-DCFPyL intravenously (IV) and then undergo PSMA-PET/CT imaging. Patients may also receive 68Ga-PSMA-11 and undergo PSMA-PET imaging at baseline as part of routine care.
After completion of study intervention, patients are followed up every 3 months for 12 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHeather Jacene
