Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
Completed · Phase 3 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00004635
- Run by
- National Cancer Institute (NCI)
- People needed
- 159
- Starts
- 2000-03-01
- Expected to finish
- 2010-03-30
- Last updated by the study team
- 2018-05-22
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Holy Cross Hospital, Fort Lauderdale — Fort Lauderdale, Florida, United States
- Louisiana State University — New Orleans, Louisiana, United States
- National Institutes of Health, Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- Wayne State University Hutzel Hospital — Detroit, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Columbia University — New York, New York, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Naval Medical Center, Portsmouth — Portsmouth, Virginia, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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