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NCT00004635 · ClinicalTrials.gov registry record · Phase 3
Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
NCT00004635: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00004635 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 159 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004635, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
Study 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 a
Primary Outcome
Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.
Interventions
- OTHER Placebo
- DRUG leuprolide acetate
- DRUG goserelin
- DRUG Thalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2000-03-01 |
| Est. Completion | 2010-03-30 |
| Phase | Phase 3 |
What the finished NCT00004635 record still lists
NCT00004635 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00004635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004635 about?
NCT00004635 is a clinical study titled "Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer". 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, re...
What is the current status of trial NCT00004635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2000-03-01. Estimated completion is 2010-03-30.
What interventions are being tested in trial NCT00004635?
The interventions under investigation include: Placebo (OTHER), leuprolide acetate (DRUG), goserelin (DRUG), Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00004635?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004635's enrollment target sits among peer trials
159 1501st of 2000 higher than 499 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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