drugset / Trial / NCT00651326

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

NCT00651326

Phase 3 Terminated 48 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer. PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer. CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.

Timeline

Start
2008-06-02
Primary completion
2010-05-14
Completion
2011-01-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule Intravenous
Comparator Bicalutamide Other / unclassified Oral
Comparator Goserelin Other / unclassified Subcutaneous
Comparator Leuprolide Other / unclassified Subcutaneous
Comparator buserelin Unknown Subcutaneous
Comparator flutamide Small molecule Oral

Indications