Protocol Number: 00-C-0080

Title:

A Double Blind Randomized Crossover Phase III Study of Oral Thalidomide versus Placebo in Patients with Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation

Number:

00-C-0080

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 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)

-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. The electrical activity of the muscle cells is recorded and analyzed by a computer. For nerve conduction testing, nerves are stimulated with brief electrical shocks through small metal electrodes attached to the skin and the conduction of the shocks is recorded and analyzed.

Patients whose PSA level rises while on leuprolide or goserelin or never falls below 5 ng/ml, or who develop metastatic disease are taken off the study. Patients whose disease recurs after the second treatment are taken off the study and may receive standard treatments from their doctor or enroll in another NCI treatment study, if an appropriate study is available.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Angiogenesis

Cancer

Hormonal Therapy

Prostate

Thalidomide

Recruitment Keyword(s):

Prostate Cancer

Condition(s):

Prostate Cancer

Investigational Drug(s):

Thalidomide

Investigational Device(s):

None

Interventions:

Drug: Thalidomide

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Thalidomide-induced peripheral neuropathy Effect of serum factor on nerve cultures

Binding of thalidomide by macromolecules in the fetal and maternal rat

Inhibition of angiogenesis by thalidomide requires metabolic activation, which is species-dependent

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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