At a glance
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A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating docetaxel, LHRH agonist, and 1 other intervention for Prostate Cancer. Active but no longer recruiting, targeting 788 participants across 226 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
75 mg/m\^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days
Given intramuscularly
Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.