Clinical Trial

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

Active, Not Recruiting Phase 3
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Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
Protocol Amendment History 523 amendments
This ClinicalTrials.gov record has been amended 523 times since 2007-01-30; most recent amendment 2023-02-08.
Status change: Recruiting → Active, Not Recruiting 2016-04-13
Trial Details
NCT Number NCT00430183
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Eastern Cooperative Oncology Group, NCIC Clinical Trials Group, SWOG Cancer Research Network
Conditions Prostate Cancer
Enrollment 788 participants
Start Date 2007-05-08
Primary Completion 2018-10-02 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2023-02-09