実臨床における転移性去勢抵抗性前立腺癌（mCRPC）患者のHRR関連遺伝子変異の有病率と予後

基本情報

NCT ID

NCT04425200

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

205

治験依頼者名

AstraZeneca

概要

The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients. \<Methods\> Study design: multi-center, prospective cohort study Data Source(s): In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern Sample Size Estimations: The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study). Statistical Analysis: This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.

対象疾患

依頼者（Sponsor）

実施施設 (26)