drugset / Trial / NCT00081159

Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

NCT00081159

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.

Timeline

Start
2004-07
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Background Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Background Goserelin Other / unclassified
Background Leuprolide Other / unclassified
Background Zoledronic acid Other / unclassified 4 mg Intravenous