Agarwal Neeraj, Azad Arun, Shore Neal D, Carles Joan, Fay Andre P, Dunshee Curtis, Karsh Lawrence Ivan, Paccagnella Maria Luisa, Santo Nicola Di, Elmeliegy Mohamed, Lin Xun, Czibere Akos, Fizazi Karim
Huntsman Cancer Institute (NCI-CCC) at the University of Utah, Salt Lake City, UT, USA.
Peter MacCallum Cancer Centre, Melbourne, Australia.
Future Oncol. 2022 Sep;18(27):2979-2986. doi: 10.2217/fon-2022-0389. Epub 2022 Aug 11.
WHAT IS THIS SUMMARY ABOUT?: This summary describes the design of an ongoing research study (also known as a clinical trial) called TALAPRO-2. The TALAPRO-2 trial is testing the combination of two medicines called talazoparib and enzalutamide as a first treatment in adult men with metastatic castration-resistant prostate cancer. The study began in December 2017 and has enrolled 1037 adult men with metastatic castration-resistant prostate cancer from 26 countries.
WHAT IS METASTATIC CASTRATION-RESISTANT PROSTATE CANCER?: Metastatic castration-resistant prostate cancer is a type of cancer that has advanced beyond the prostate and continues to grow even when testosterone levels in the blood are suppressed.
WHICH MEDICINES ARE BEING TESTED?: The combination of talazoparib plus enzalutamide will be compared with enzalutamide plus placebo. Enzalutamide is approved to treat men with prostate cancer. Talazoparib is not approved to treat men with prostate cancer. A placebo does not contain any active ingredients and is also known as a sugar pill.
WHAT ARE THE AIMS OF THE TALAPRO-2 TRIAL?: The TALAPRO-2 trial will find out if combining talazoparib with enzalutamide increases the length of time the men in the study live without their cancer getting worse compared with enzalutamide plus placebo. The study will also measure how long men in the study live and any side effects the men have while they are taking the study medicines. Researchers are also testing the DNA from the tumor cells of all men in the study to find out if they have faulty DNA repair genes. : NCT0339519 (ClinicalTrials.gov).
本摘要内容是什么？：本摘要描述了一项正在进行的名为TALAPRO-2的研究（也称为临床试验）的设计。TALAPRO-2试验正在测试两种药物他拉唑帕尼和恩杂鲁胺联合使用，作为成年转移性去势抵抗性前列腺癌男性的一线治疗方案。该研究于2017年12月开始，已招募了来自26个国家的1037名成年转移性去势抵抗性前列腺癌男性。
什么是转移性去势抵抗性前列腺癌？：转移性去势抵抗性前列腺癌是一种已扩散至前列腺以外的癌症，即使血液中的睾酮水平受到抑制，它仍会继续生长。
正在测试哪些药物？：他拉唑帕尼加恩杂鲁胺的联合用药将与恩杂鲁胺加安慰剂进行比较。恩杂鲁胺已被批准用于治疗前列腺癌男性。他拉唑帕尼未被批准用于治疗前列腺癌男性。安慰剂不含任何活性成分，也称为糖丸。
TALAPRO-2试验的目的是什么？：TALAPRO-2试验将确定与恩杂鲁胺加安慰剂相比，他拉唑帕尼与恩杂鲁胺联合使用是否能延长研究中的男性患者在癌症不恶化情况下的生存时间。该研究还将测量研究中的男性患者的生存时间以及他们在服用研究药物时出现的任何副作用。研究人员还在测试研究中所有男性患者肿瘤细胞的DNA，以确定他们是否有缺陷的DNA修复基因。：NCT0339519（ClinicalTrials.gov）。
