Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABazitaxel to Alternative Androgen Receptors (AR) Targeted Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 8
- 试验地点
- 24
- 主要终点
- Radiographic Progression-Free Survival (rPFS)
研究概览
简要总结
Primary Objective:
To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months).
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).
- Progression Free Survival (PFS).
- Overall Survival (OS).
- Tumor response rate in participants with measurable disease (RECIST 1.1)
- Pain response and time to pain progression.
- Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.
- To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).
- To evaluate safety in the 2 treatment arms.
详细描述
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cabazitaxel
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
干预措施: Cabazitaxel XRP6258 (Drug)
Cabazitaxel
Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
干预措施: Prednisone (Drug)
Abiraterone acetate or Enzalutamide
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
干预措施: Ezalutamide (Drug)
Abiraterone acetate or Enzalutamide
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
干预措施: Abiraterone acetate (Drug)
Abiraterone acetate or Enzalutamide
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
干预措施: Prednisone (Drug)
结局指标
主要结局
Radiographic Progression-Free Survival (rPFS)
时间窗: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
次要结局
- Percentage of Participants With Symptomatic Skeletal Event (SSE)(Baseline until the end of study (maximum duration: 1059 days))
- Number of Participants With Prostate Specific Antigen (PSA) Response(Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days))
- Time to Occurrence of Any Symptomatic Skeletal Events (SSE)(Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days))
- Duration of Tumor Response(Baseline up to disease progression or death due to any cause (maximum duration: 1059 days))
- Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score(Baseline until the end of study (maximum duration: 1059 days))
- Time to Pain Progression(Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days))
- Overall Survival(Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days))
- Time to PSA Progression(Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days))
- Number of Participants Achieving Tumor Response(Baseline up to disease progression or death due to any cause (maximum duration: 1059 days))
- Progression-free Survival (PFS)(Baseline upto progression or death due to any cause (maximum duration: 1059 days))