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Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

NCT ID: NCT04601441

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Metastatic Castration-sensitive Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Apalutamide

Apalutamide 240 mg administered orally once a day as four 60 mg tablets

Group Type OTHER

Apalutamide

Intervention Type DRUG

Apalutamide 240 mg administered orally once a day as four 60 mg tablets

Interventions

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Apalutamide

Apalutamide 240 mg administered orally once a day as four 60 mg tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role collaborator

Kindai University

OTHER

Sponsor Role lead

Responsible Party

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Hirotsugu Uemura

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hirotsugu Uemura, MD, PhD

Role: STUDY_CHAIR

Department of Urology, Kindai University Faculty of Medicine

Locations

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Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hiroshi Yoshida

Role: CONTACT

Phone: +81-3-3830-1074

Email: [email protected]

Facility Contacts

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Hirotsugu Uemura, MD, PhD

Role: primary

Other Identifiers

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jRCTs071200040

Identifier Type: REGISTRY

Identifier Source: secondary_id

56021927PCR4013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

56021927PCR4013

Identifier Type: -

Identifier Source: org_study_id