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临床试验/NCT04962880
NCT04962880已完成不适用

Prevalence of Homologous Recombination Repair (HRR) Gene Mutations in Patients With Metastatic Castration-resistant Prostate Cancer in Latin America: PROSPECT Study.

AstraZeneca1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2021年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
388
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America (LatAm) between February 2021 and January 2022.

详细描述

Background/Rationale: Prostate cancer(PC)is the second most frequent cancer diagnosis made in men and the fifth leading cause of death worldwide(1). Variations in the incidence rates world wide reflect differences in multiple epidemiological variables depending on the different regions. It is known that in Central America is the leading cause of cancer death in men. For South America, it is the second cause of cancer death and the third in North America(2). Estimations from 2012 from Brazil reported over 60,000 new cases. While in 2017 the United States (US) reported more than 160,000 new cases, represent in gone in five diagnosis of cancer in men (3-5).

The incidence of castration-resistant prostate cancer (CRPC)has been reported in several studies in various regions of the world, but unfortunately in Latin America data are incomplete. A comprehensive systematic review including 71,179 patients observed for up to 12 years, indicated that 10.0-20.0% of PC patients developed CRPC within approximately five years of follow-up. Over 84.0% of them had metastases present at the time of CRPC diagnosis, and 33.0% of those without metastases at diagnosis developed them within two years (3,4). Currently, patients with metastatic CRPC (mCRPC) have an overall survival rate between 9 and 13 months and is associated with bone metastases and poor quality of life (3.7). The negative prognosis of mCRPC may be associated in part with few and limited therapeutic options. In the past decade, there have been few new treatment options for this group of patients becoming an unmet need, but the development of targeted therapies and the application of PCD-damaged DNA repair mutation detection (DDR) tests allow patient classification and offer them important treatment options, particularly in advanced stages of the disease where current options are limited (8,9).

Objectives and Hypotheses Primary Objective: Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America(LatAm) between February 2021 and January 2022.

Exploratory objectives

  1. Describe the demographic and clinical characteristics of the mCRPC participants with HRR gene mutations in LatAm between February 2021 and January 2022.
  2. Describe the association between demographic and clinical characteristics, and the prevalence of HRR gene mutations in participants with mCRPC per LatAm country between February 2021 and January 2022.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Participants aged≥18
  • Pathological mCRPC cases confirmed by histopathological report.
  • Evidence of a previous methastatic primary PC
  • Availability to provide medical history data(demographic information and history of cancer).
  • Availability to provide blood and/or tissue sample in case it is available
  • Participants who are able to sign the informed consent form(ICF).

排除标准

  • Diagnosis of any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results
  • Inability of participant to provide informed consent.

结局指标

主要结局

Primary Outcome

时间窗: Q1 2021 - Q1 2022

To know the prevalence and type of Homologous Recombinational Repair (HRR) mutations identified in Formalin-fixed paraffin-embedded (FFPE) tissue or blood samples in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) in the selected participants countries in LatAm. A molecular test formulary would be completed when tissue sample is analyzed * Preservation time (years) * Origin of the FFPE (organ) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS") A molecular test formulary would be completed when blood sample is analyzed * Date of extraction (date) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS")

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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