18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

August 3, 2017

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2030

Conditions
Prostate NeoplasmsProstatic CancerProstate CancerCancer Of ProstateMetastatic Prostate Cancer
Interventions
DRUG

18F-DCFPyL

Subjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi.

DRUG

18F-FDG

Cohort 2 may receive a one-time 18F-FDG PET/CT after a positive 18F-DCPyL PET/CT. 18F FDG PET/CT imaging may be performed per clinical standard of care. FDG is administered at a dose of 10mCi intravenously. A whole-body PET/CT will be performed beginning post 18F FDG injection.

DRUG

PSMA-11

For up to 10 eligible patients from either cohort 1 or 2, an optional salivary gland blocking study may be performed in which a salivary gland is cannulated and injected with unlabeled DCFPyL or PSMA-11.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH