Status:
COMPLETED
Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Kyoto University, Graduate School of Medicine
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
20+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00685646
Start Date
May 1 2008
End Date
January 1 2014
Last Update
October 16 2015
Active Locations (1)
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1
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507