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

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