Skip to main content
Clinical Trials/JPRN-jRCTs071200040
JPRN-jRCTs071200040Active, not recruitingPhase 4

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

emura Hirotsugu0 sites100 target enrollmentStarted: October 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
Male

Inclusion Criteria

  • 1. Men aged 20 years or older.
  • 2. Participant has documented diagnosis of metastatic PC with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
  • 3. Participant has metastatic PC that is castration naive 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.
  • 4. 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.
  • 5. Participant is willing to receive apalutamide for mCSPC in the participating site of this study.
  • 6. Participant is of Japanese nationality.
  • 7. 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

  • 1.Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA typing.
  • 2.Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide.
  • 3.Participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert).
  • 4.Participant has contraindications to the use of ADT based on routine treatment.
  • 5.Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.

Investigators

Sponsor
emura Hirotsugu

Similar Trials