Clinical trial · Interventional
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
NCT04601441CI-TRIAL-00048676CUARTETunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-sensitive Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apalutamide | Drug | Apalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Apalutamide
- description
- Apalutamide 240 mg administered orally once a day as four 60 mg tablets
- interventionNames
- Drug: Apalutamide
Primary outcomes (1)
- measure
- Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.
- timeFrame
- Three years or more, 4.5 years or less
- description
- Seventy-three PC driver genes from ctDNA including ARID1A, HSD3B1, MDM4, AKT3, MSH2, MSH6, ERCC3, NFE2L2, IDH1, FANCD2, MLH1, CTNNB1, FOXP1, RYBP, PIK3CB, ATR, PIK3CA, FBXW7, PIK3R1, CHD1, APC, FANCE, CDK6, MET, BRAF, CUL1, KMT2C, NKX3-1, CLU, NCOA2, MYC, CDKN2A, FANCG, FANCC, PTEN, FANCF, CCND1, ATM, ZBTB16, CDKN1B, KRAS, KMT2D, CDK4, MDM2, BRCA2, RB1, ERCC5, FOXA1, RAD51B, AKT1, IDH2, ERCC4, ZFHX3, FANCA, TP53, CDK12, BRCA1, SPOP, RNF43, RAD51C, AKT2, ERCC2, ERCC1, ASXL1, GNAS, RUNX1, ERG, TMPRSS2, KDM6A, AR, MED12, SMARCA1, and PALB2.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.