NCT03652493已完成2 期
Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Centre Francois Baclesse8 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate
研究概览
简要总结
The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.
This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
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
- •Patients > 18 years old
- •Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)
- •Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study
- •Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.
- •Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:
- •Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance
- •Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment.
- •Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide)
- •Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP)
- •Performance Status <2
- •Metastatic disease progressive
排除标准
- •Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.
- •Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)
- •No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment
- •Previous treatment with platinum
- •Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.
研究组 & 干预措施
CARBOPLATIN
Experimental
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate
时间窗: Up to 27 weeks (9 cycles)
Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response
Efficacy of carboplatin: biological response rate defined by value of PSA
时间窗: Up to 27 weeks (9 cycles)
Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,
次要结局
未报告次要终点
研究者
研究点 (8)
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