A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Time to treatment failure (TTF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
干预措施: antiandrogen therapy (Drug)
Arm I
Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
干预措施: zoledronic acid (Drug)
Arm II
Patients receive maximum androgen-blockade therapy for up to 24 courses.
干预措施: antiandrogen therapy (Drug)
结局指标
主要结局
Time to treatment failure (TTF)
时间窗: 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.
次要结局
- 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)