A Phase I Trial of Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Anti-prostate-specific Membrane Antigen Monoclonal Antibody in Patients With Metastatic, Castrate-resistant Prostate Cancer
This research is being done because the standard treatments for metastatic prostate cancer
that is growing despite medical or surgical therapies are not curative. Existing
treatments, such as the docetaxel used as part of this study, may work temporarily, but
unfortunately the cancer continues to grow. This test drug, 177Lu-J591, is designed to seek
out prostate cancer cells and deliver a lethal dose of radiation to the areas of cancer, but
not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive
some radiation dose that is within the acceptable limits.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Determine the maximum tolerated dose of fractionated 177Lu-DOTA-J591 administered concurrently with three-weekly docetaxel for the treatment of patients with metastatic, castrate-resistant prostate cancer.
4 weeks post last J591 dose
Scott Tagawa, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|
|University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|