EUCTR2016-005284-13-IT进行中（未招募）1 期
A 2 arm, phase II controlled randomized trial comparing efficacy and safety of abiraterone and abiraterone associated with Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial) - ARTO
DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE0 个研究点目标入组 174 人开始时间: 2021年2月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 174
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Metastatic disease and only minor or equal at 3 metastatic sites recorded (irrespective if nodal or bone).
- •2. Patients should have received abiraterone acetate for 30 days before start of radiotherapy (+ or – 3 days)
- •3. Asymptomatic or mildly symptomatic pa-tients according to clinical judgement.
- •4.Age more and equal 18 years.
- •5.Subject must have signed an informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •1.More than 3 metastatic lesions.
- •2.Visceral envolvement.
- •3.Known or suspected contraindications or hypersensitivity to Abiraterone, GnRH agonist/antagonist or Radiotherapy.
- •4.Comorbidities that contraindicate Abiraterone, GnRH agonist/antagonist or Radiotherapy.
- •5.Any condition for which, in the option of the investigator, participation would not be in the best interest of subject.
- •6.Patients who received previous therapies for mCRPC (excluded ormonal therapy)
研究者
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