Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
Condition: Metastatic Castration-sensitive Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04601441
Sponsor: Kindai University
Phase: Phase 4
- Age: minimum 20 Years maximum N/A
- Gender: Male
- Men aged ≥20 years.
- Participant has documented diagnosis of metastatic PC with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
- Participant has metastatic PC that is castration naïve 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.
- 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.
- Participant is willing to receive apalutamide for mCSPC in the participating site of this study.
- Participant is of Japanese nationality.
- 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.
- Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA typing.
- Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide.
- Participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert).
- Participant has contraindications to the use of ADT based on routine treatment.
- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.
View trial on ClinicalTrials.gov