Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.
研究概览
简要总结
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Apalutamide
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
干预措施: Apalutamide (Drug)
结局指标
主要结局
Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.
时间窗: Three years or more, 4.5 years or less
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.
次要结局
- The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- PFS stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- OS stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- PFS2 stratified by baseline genomic alterations for 73 PC driver genes(Three years or more, 4.5 years or less)
- Safety in the usual clinical practice based on adverse events(From apalutamide initiation to 30 days after the last dose)
- Safety in the usual clinical practice based on potential skin rash events(From apalutamide initiation to 30 days after the last dose)
研究者
Hirotsugu Uemura
Professor
Kindai University