Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

OBJECTIVES:

• Evaluate the time to treatment failure in prostatic cancer patients with metastatic bone disease receiving maximum androgen-blockade therapy with vs without zoledronic acid.
• 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.

Inclusion criteria

• Patients with definitive diagnosis of prostatic cancer by histopathological diagnosis or cytology
• Androgen blockade therapy-, systemic chemotherapy-, bisphosphonates-naïve prostatic cancer patients
• Patients who are sensitive to androgen blockade therapy
• Patients with bone metastasis on bone scan (EOD ≥ 1)
• Patients who have Eastern Cooperative Oncology Group performance status (ECOG: 0-2)
• Patients who have prostate-specific antigen performance status (PSA ≧30 ng/mL)
• Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.

• Leukocyte count ≥ 3,000/μL
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 7.5 × 10^4/μL
• Serum creatine level ≤ 3.0 mg/dL
• 8.5 mg/dL ≤ corrected serum level of calcium ≤ 11.5 mg/dL
• Total bilirubin ≤ 1.8 mg/dL
• Aspartate aminotransferase (AST) Levels ≤ 90 IU/L
• Alanine aminotransferase (ALT) Levels ≤ 100 IU/L
• Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation

Exclusion criteria

• Patients with poorly-controlled dental caries
• Patients with double cancer that requires treatment
• Patients who are using following steroid drugs (except for topical ointment)
• Patients with poorly-controlled hypertension or cardiovascular disease
• Patients with active infectious diseases or HIV or hepatitis virus infections
• Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

• No prior androgen-blockade therapy
• No prior or other concurrent anticancer therapy
• No prior or concurrent immunologic adjuvant therapy
• No prior or concurrent steroid drugs (except ointment)
• No other prior or concurrent bisphosphonates (excluding zoledronic acid)
• No prior systemic chemotherapy