Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Response rate
研究概览
简要总结
Hypothesis
The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
详细描述
Design
-
Type: Phase 2, prospective, open-label, multicenter, single-cohort.
-
Inclusion Criteria:
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Patients with standard indication for intensification:
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M0 high/very high risk candidates for RT (Abiraterone [ABI] for 2 years + ADT for 3 years per STAMPEDE), or
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mHSPC: candidates for doublet (ADT+ABI) or triplet (ADT+Docetaxel+ABI); without ADT during the first 30 days.
Objectives and Endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥18 years.
- •Histologically confirmed prostate adenocarcinoma.
- •Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia).
- •Indicated for hormonal intensification (high/very high risk candidates for RT, or mHSPC for doublet/triplet).
- •No prior ADT.
- •ECOG 0-2; adequate hepatic/renal function; K+ ≥3.5 mmol/L; controlled BP.
排除标准
- •Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.
- •Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment.
研究组 & 干预措施
single-cohort
Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
干预措施: Abiraterone 250 mg with food + prednisone (Drug)
结局指标
主要结局
Response rate
时间窗: 3 months
Response per PCWG3
次要结局
未报告次要终点