跳至主要内容
临床试验/JPRN-jRCTs071200040
JPRN-jRCTs071200040进行中(未招募)4 期

Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan - CUARTET Study

emura Hirotsugu0 个研究点目标入组 100 人开始时间: 2020年10月9日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
Male

入选标准

  • 1. Men aged 20 years or older.
  • 2. Participant has documented diagnosis of metastatic PC with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
  • 3. Participant has metastatic PC that is castration naive or castration sensitive and is permitted to receive less than 6 months ADT or CAB before registration and less than 36 months neoadjuvant or adjuvant hormonal therapy.
  • 4. If a participant is treated with ADT or CAB, he has maintained a response to hormonal therapy of stable disease or better, by investigator assessment of imaging and PSA.
  • 5. Participant is willing to receive apalutamide for mCSPC in the participating site of this study.
  • 6. Participant is of Japanese nationality.
  • 7. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

排除标准

  • 1.Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA typing.
  • 2.Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide.
  • 3.Participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert).
  • 4.Participant has contraindications to the use of ADT based on routine treatment.
  • 5.Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.

研究者

发起方
emura Hirotsugu

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