Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

February 21, 2012

Primary Completion Date

February 21, 2026

Study Completion Date

February 21, 2026

Conditions
Prostate Cancer
Interventions
DRUG

89Zr-DFO-huJ591

The first 10 patients enrolled in the study will undergo serial whole-body scans to allow assessment of 89Zr-DFO-huJ591 biodistribution. There will be no intervening changes in therapy between the scans. The first 10 patients enrolled will also have serial blood samples drawn for PK analysis (2 -3 mL per time point). The remaining 90 patients enrolled (Patients 11-100) will have only 1 whole-body scan, at a time point to be determined based on the results for the first 10 patients. Biopsies are not mandatory, but highly recommended for the scientific purposes of the study. If feasible and the patient consents, all patients will undergo either or both of the following: (a) core biopsy of soft tissue site of disease; (b) core biopsy of bony site of disease. These biopsies will be performed following the last whole-body scan, prior to initiation of a new intervening therapy, and no more than 4 weeks after 89Zr-DFO-huJ591 administration.

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Broad Institute of MIT and Harvard

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01543659 - Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer | Biotech Hunter | Biotech Hunter