A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease
- Evaluate the time to treatment failure in prostatic cancer patients with metastatic
bone disease receiving maximum androgen-blockade therapy with vs without zoledronic
- Evaluate the time to first skeletal-related events in these patients.
- Evaluate the overall survival of these patients.
- Evaluate the extent of disease on bone scan in these patients.
- Evaluate the pain scale and FACES pain-rating scale in these patients.
- Evaluate the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive maximum androgen-blockade therapy and zoledronic acid for up to
24 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive maximum androgen-blockade therapy for up to 24 courses in the
absence of disease progression or unacceptable toxicity.
Allocation: Randomized, Primary Purpose: Treatment
Time to treatment failure
Osamu Ogawa, MD, PhD
United States: Federal Government