A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy
This research is being done because the standard treatments for prostate cancer that has
returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal
therapy are not curative. Existing treatments, such as the ketoconazole used as part of
this study may decrease PSA temporarily, but unfortunately the cancer continues to grow.
This experimental drug is designed to seek out all of the prostate cancer cells and to
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.
The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591".
It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very
energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is
attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study
will assess the potential of the energy given off by the radioactive compound to kill cancer
cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also
an energetic radioactive particle, but does not generally give off enough energy to kill
cancer cells, but allows researchers to take pictures. This radioactive particle is also
attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment
with no active medicine).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion free of radiographically evident metastases at 18 months by CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan
Scott T Tagawa, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|University of Utah||Salt Lake City, Utah|
|Emory University||Atlanta, Georgia 30322|
|Georgetown University Medical Center||Washington, District of Columbia 20007|
|University of Arizona Cancer Center||Tucson, Arizona 85724|
|Weill Cornell Medical College||New York, New York 10021|
|The University of Kansas Cancer Center||Kansas City, Kansas 66160|
|Cedars Sinai||Los Angeles, California 90048|