Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan (CUARTET)

Kindai University

Status and phase

Enrolling

Phase 4

Conditions

Metastatic Castration-sensitive Prostate Cancer

Treatments

Drug: Apalutamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04601441

jRCTs071200040 (Registry Identifier)

56021927PCR4013 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.