Sequential Abiraterone following Docetaxel Chemotherapy in Hormone Sensitive Metastatic Prostate Cancer
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- For Phase II:
研究概览
简要总结
**1.**ProstateCancer is the second most common malignancy worldwide. Thegrowth of prostate cancer is stimulated by male hormone (testosterone) i.e. Prostate Cancer is androgen dependent and canbe successfully treated with either surgical or medical castration. Androgen-deprivationtherapy in addition with Docetaxel is proved to be a standard of care for menwith metastatic, castration-sensitive Prostate Cancer. Previous studieshave proved that both Docetaxel and Abirateronehave been used in metastatic Hormone sensitive prostate cancer. Both haveproved to increase the OS as well as the quality of life of patients. Themechanism of action of both the agents is different. Barriers to the use ofDocetaxel include advanced patient age, poor performance status, coexistingillnesses and patient preferences. The Objectives of the study includes to evaluate the ability ofsequential Abiraterone to improve PSA PFS and OS in patients with hormonesensitive metastatic Prostate Cancer post hormone therapy + Docetaxel chemotherapy in Phase II and III respectively. It is a two arm, parallel design,open label, sequential Phase 2/3 randomized controlled trial. In arm A, observationwould be done. The schedule of observation will be in accordance with theinstitutional follow up protocol i.e patient would be followed up at 3 monthlyintervals. FACIT QOL Prostate would be filled at baseline, and 6 monthlyinterval. In arm B, sequential Abiraterone would be administered. The patientswill be followed with CBC and biochemistry after one month. If patienttolerates well, then patients will be followed after 2 months, then every 3monthly. The patients would be followed up for two years after completing theenrollment in phase II and three years in phase III part of study in both thearms. The expected outcomes are improvement in PSA PFA and OS in Phase II andIII respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants must be hormone sensitive prostate cancer for a histologically confirmed adenocarcinoma of prostate.
- •ECOG performance status ≤
- •Participants must have normal organ and marrow function.
排除标准
- •Participants who are receiving any other investigational agents.
- •Participants who are designated as unfit for receiving Abiraterone based chemotherapy.
结局指标
主要结局
For Phase II:
时间窗: 5 years
PSA PFS: The interval between randomization and the date of documented progression or death before documented progression or treatment stopped due to any reason. Patients who have not progressed or died at their last follow ups would be censored.
时间窗: 5 years
For Phase III:
时间窗: 5 years
OS : OS will be defined as time period between date of randomization to date of death due to any cause. Patients alive at their last follow ups would be censored.
时间窗: 5 years
次要结局
- Toxicity: To compare CTCAE version 4.03 worst grade toxicity between the 2 arms during any period of chemotherapy.(Overall Quality of Life: The Functional Assessment of Cancer Therapy-Prostate (FACIT-P) is a self report measure of both general and disease specific quality of life.)