Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kindai University
• Collaborator: Janssen Pharmaceutical K.K.

Criteria

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.