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TALAPRO-3 研究设计:通俗易懂的概述。

The TALAPRO-3 study design: a plain language summary.

机构信息

Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA.

University of Montréal Cancer Center, Montréal, Canada.

出版信息

Future Oncol. 2024;20(30):2225-2231. doi: 10.1080/14796694.2024.2363131. Epub 2024 Jul 24.

DOI:10.1080/14796694.2024.2363131
PMID:39451095
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11524196/
Abstract

WHAT IS THIS SUMMARY ABOUT?: This summary is about the ongoing research study called TALAPRO-3. This study is testing the use of two medicines called talazoparib and enzalutamide. The two medicines are being used together as a treatment for patients with a type of cancer called metastatic castration-sensitive prostate cancer and changes in specific DNA repair genes within their tumors. The study began in May 2021, and includes 599 patients from 27 countries.

WHAT IS METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER?: Metastatic castration-sensitive prostate cancer is known as mCSPC for short. It is cancer that has started in the prostate and spread to other body parts. The prostate is a gland below the bladder and helps make semen (the liquid that contains sperm). Castration-sensitive means that the cancer responds to treatments that lower testosterone in the blood.

WHICH MEDICINES ARE BEING TESTED?: In this study, some patients will take talazoparib plus enzalutamide while others will take a placebo plus enzalutamide. Talazoparib and enzalutamide are two different cancer medicines. Talazoparib is not currently used to treat patients with mCSPC. Enzalutamide is used to treat patients with prostate cancer. Talazoparib plus enzalutamide is being compared with a placebo plus enzalutamide to see if patients live longer without their cancer getting worse, or them dying, when taking talazoparib plus enzalutamide or when taking a placebo plus enzalutamide.

WHAT ARE THE AIMS OF THE TALAPRO-3 STUDY?: This study aims to find out if treatment with talazoparib plus enzalutamide increases the length of time the patients in the study live without their cancer getting worse, or them dying, compared with treatment with a placebo plus enzalutamide. The study will also measure how long the patients in the study live, the number and types of side effects they have, their general health and quality of life, and whether there are changes in how patients report their pain. NCT03395197 (TALAPRO-2) (ClinicalTrials.gov).

摘要

这篇摘要介绍了一项名为 TALAPRO-3 的研究。该研究正在测试两种药物——他拉唑帕利和恩扎卢胺的联合应用。这两种药物联合用于治疗一种名为转移性去势敏感前列腺癌的癌症,以及肿瘤中特定 DNA 修复基因的改变。该研究于 2021 年 5 月开始,共有来自 27 个国家的 599 名患者参与。

转移性去势敏感前列腺癌简称 mCSPC。它是指起源于前列腺并扩散到身体其他部位的癌症。前列腺是膀胱下方的一个腺体,有助于产生精液(含有精子的液体)。去势敏感意味着癌症对降低血液中睾丸激素的治疗有反应。

在这项研究中,一些患者将接受他拉唑帕利加恩扎卢胺治疗,而另一些患者将接受安慰剂加恩扎卢胺治疗。他拉唑帕利和恩扎卢胺是两种不同的癌症药物。他拉唑帕利目前尚未用于治疗 mCSPC 患者。恩扎卢胺用于治疗前列腺癌患者。他拉唑帕利加恩扎卢胺与安慰剂加恩扎卢胺进行比较,以观察患者在接受他拉唑帕利加恩扎卢胺或安慰剂加恩扎卢胺治疗时,癌症恶化或死亡的时间是否更长,即无进展生存期是否更长。

该研究旨在确定与安慰剂加恩扎卢胺相比,他拉唑帕利加恩扎卢胺治疗是否能延长患者的无进展生存期,即癌症恶化或死亡的时间。该研究还将测量患者的生存时间、他们出现的副作用的数量和类型、他们的总体健康状况和生活质量,以及患者报告疼痛的方式是否有变化。NCT03395197(TALAPRO-2)(ClinicalTrials.gov)。

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Future Oncol. 2024;20(30):2225-2231. doi: 10.1080/14796694.2024.2363131. Epub 2024 Jul 24.
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