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
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