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: 2024年1月22日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

emura Hirotsugu