NCT01809691已完成3 期
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,313
- 试验地点
- 558
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of metastatic prostate cancer.
- •Serum testosterone within institutional limits of normal.
- •PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
- •DEXA scan within 2 years prior to registration.
- •ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
- •LVEF within 42 days prior to registration and within institutional limits of normal.
- •Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
- •Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
- •Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
- •Zubrod performance status of 0 -
- •Zubrod performance status 3 will be allowed if from bone pain only.
- •≥ 18 years of age.
- •Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.
排除标准
- •Known brain metastases.
- •No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
- •≥ 6 months since completion of androgen deprivation therapy.
- •Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
- •Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
- •≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
- •Concurrent use of experimental therapy is not allowed.
- •≥ 30 days since prior medical castration for metastatic prostate cancer.
- •If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
- •If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
- •Prior bilateral orchiectomy.
- •Concurrent use of LHRH antagonists (e.g. Degarelix)
- •Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
- •Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
- •Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
- •History of primary and secondary adrenal insufficiency.
- •Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
- •Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
研究组 & 干预措施
ADT + TAK-700
Experimental
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
干预措施: TAK-700 (Drug)
ADT + Bicalutamide
Active Comparator
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Overall Survival
时间窗: Duration of treatment and follow-up until death or 9 years after study start
Overall survival is defined as the time from random assignment to the date of death from any cause
次要结局
- PSA Response Rates(7 months after randomization)
- Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs(Duration of treatment and follow-up until death or 9 years after study start)
- Long-term Survival(After 10 years of follow-up)
- Progression Free Survival(Duration of treatment and follow-up until death or 9 years after study start)
研究者
研究点 (558)
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