A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease
Overview
- Phase
- Phase 3
- Intervention
- antiandrogen therapy
- Conditions
- Metastatic Cancer
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Enrollment
- 227
- Locations
- 1
- Primary Endpoint
- Time to treatment failure (TTF)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 caused by bone metastasis. It is not yet known whether androgen-blockade therapy is more effective with or without zoledronic acid in treating patients with prostate cancer that has spread to the bone.
PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together with zoledronic acid to see how well it works compared with androgen-blockade therapy alone in treating patients with prostate cancer and bone metastases.
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 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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
Intervention: antiandrogen therapy
Arm I
Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
Intervention: zoledronic acid
Arm II
Patients receive maximum androgen-blockade therapy for up to 24 courses.
Intervention: antiandrogen therapy
Outcomes
Primary Outcomes
Time to treatment failure (TTF)
Time Frame: 6 years
The interval from the date of randomization to the earliest date on which prostate-specific antigen (PSA) progression, clinical progression, first skeletal-related events (SRE), death, or cessation of protocol treatment for any reason occurred.
Secondary Outcomes
- Time to first skeletal-related events (SRE)(6 years)
- Overall survival(6 years)
- Extent of disease on bone scan (EOD)(Baseline, Month 12, 24 and 36)
- Pain scale(Baseline, Month 12, 24 and 36)
- FACES pain-rating scale(Baseline, Month 12, 24 and 36)
- Adverse events(Month 6, 12, 18, 24 and 30)
- QOL (SF-36)(Month 6, 12, 18, 24, 30 and 36)