Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan (NCT04601441) | Clinical Trial Compass
UnknownPhase 4
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
Japan100 participantsStarted 2020-11-06
Plain-language summary
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
Who can participate
Age range20 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.