Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
Status:
Completed
Trial end date:
2010-03-30
Target enrollment:
Participant gender:
Summary
This multi-center study will evaluate whether thalidomide can improve the effectiveness of
the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer.
Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone
production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used
for many years to treat leprosy, blocks the growth of blood vessels that may be important to
disease progression.
Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or
recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has
not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are
screened with a medical history and physical examination, including blood tests, bone and
computed tomography (CT) scans or other imaging studies.
Study participants are randomly assigned to one of two treatment groups. One group receives
leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin
followed by placebo (a look-alike pill with no active ingredients). Patients in both groups
receive an injection of leuprolide or goserelin once a month for 6 months. After that time
they take four capsules of either thalidomide or placebo once a day and remain on the drug
until their prostate-specific antigen (PSA) level returns to what it was before beginning
leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein
secreted by the prostate gland. Monitoring changes in levels of this protein can help
evaluate tumor progression). At this point the entire procedure begins again, starting with
leuprolide or goserelin treatment, but the experimental drug is switched; patients originally
treated with thalidomide are crossed over to placebo, and patients originally treated with
placebo are crossed over to thalidomide.
Patients are monitored periodically with the following tests and procedures:
Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and
PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and
kidney and liver function).
Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the
tumor.
Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin
needle is inserted into a few muscles and the patient is asked to relax or to contract the
muscles.
Phase:
Phase 3
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborators:
Columbia University Holy Cross Hospital, Fort Lauderdale Louisiana State University Health Sciences Center in New Orleans United States Naval Medical Center, Portsmouth University of Minnesota University of Minnesota - Clinical and Translational Science Institute University of Pittsburgh University of Washington Wayne State University