Overview
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
Description
This clinical study is an open-label, multicenter, interventional, Phase 4 study to evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment in patients with mCSPC. A total of 100 participants to be treated by apalutamide will be registered in this study. All participants will undergo blood collection for ctDNA, single-nucleotide polymorphisms (SNPs), and human-leukocyte antigen (HLA) typing at pre- and posttreatment of apalutamide.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.