ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
研究概览
简要总结
Study wants to explore real-world data in three distinct settings
- Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
- Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
- Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18y
- •Cytological or Histologically confirmed diagnosis of PC
- •Histologically or radiologically confirmed diagnosis of metastatic disease and
- •For ARON-3S
- •▪ Treatment with ADT + Apalutamide or ADT + enzalutamide or ADT + Abiraterone or ADT + Abiraterone + Docetaxel or ADT + Darolutamide + Docetaxel (patients treated with previous docetaxel - CHAARTED - resulted eligible)
- •For ARON-3Lu
- •▪ Treatment with Luthetium-177-PSMA therapy for castration resistant PC
- •For ARON-3GEN
- •HRD POSITIVE STATUS
- •Treatment with PARP inhibitors for castration resistant PC. Treatment included: olaparib (as 1st, 2nd or 3rd line therapy), olaparib + abiraterone (as 1st line therapy) or niraparib + abiraterone (as 1st line therapy) or talazoparib + enzalutamide
排除标准
- •Patients without histologically confirmed diagnosis of PC
- •Patients without histologically or radiologically confirmed metastatic disease and
- •For ARON-3S
- •▪ Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section
- •For ARON-3Lu
- •▪ Patients treated with Luthetium-177-PSMA therapy for hormone/castration sensitive PC
- •For ARON-3GEN
- •HRD NEGATIVE STATUS
- •Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study
结局指标
主要结局
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
时间窗: January 31h, 2024- May 31th, 2024
Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
时间窗: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
时间窗: January 31h, 2024- May 31th, 2024
Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
时间窗: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
时间窗: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
时间窗: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
时间窗: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
时间窗: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
时间窗: January 31h, 2024- May 31th, 2024
次要结局
- Time to progression of patients with different metastatic sites treated by the distinct combinations(January 31h, 2024- May 31th, 2024)
- prognostic role of lifestyle and concomitant medications(January 31h, 2024- May 31th, 2024)
研究者
Matteo Santoni
Medical Doctor, Principal Investigator
Hospital of Macerata