Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer

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.

Conditions

• Prostate Cancer

Interventions

DRUG

Thalidomide

Thalidomide 200 mg given orally every evening at 9pm. Treatment may continue indefinitely provided that there are no dose-limiting toxicity.

DRUG

leuprolide acetate

Injections of leuprolide once a month for six months.

DRUG

goserelin

Injections of Goserelin once a month for six months.

OTHER

Placebo

Patients will receive the placebo if they initially received thalidomide. The starting dose of placebo 200 mg (four capsules of 100-50 mg capsules) orally once daily at bedtime.

Sponsors & Collaborators

• Holy Cross Hospital, Fort Lauderdale

  collaborator UNKNOWN

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• United States Naval Medical Center, Portsmouth

  collaborator FED

• University of Washington

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• William L Dahut, M.D. · National Cancer Institute, National Institutes of Heath

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-03-01

Primary Completion

2005-01-30

Completion

2010-03-30

FDA Drug

Yes

Countries

• United States

Study Locations