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Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan

NCT04601441•Kindai University

View on ClinicalTrials.gov

Summary

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

Detailed 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

Age

20 - No limit years

Sex

MALE

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.

Locations (1)

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Key Dates

Start Date

November 6, 2020

Primary Completion Date

March 31, 2025

Completion Date

March 31, 2025

Last Updated

December 8, 2020

Enrollment

100

ESTIMATED participants

Conditions

Metastatic Castration-sensitive Prostate Cancer

Interventions

Apalutamide

DRUG

Contacts

Hiroshi Yoshida

CONTACT

+81-3-3830-1074 ctDNA@a2healthcare.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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