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.
Clinical Trial Registration: NCT03395197 (TALAPRO-2) (ClinicalTrials.gov)
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
The original article is titled ‘TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer’.
You can read the original article for free at: https://www.tandfonline.com/doi/full/10.2217/fon-2023-0526
Financial disclosure
The TALAPRO-3 trial is sponsored by Pfizer Inc. Astellas Pharma Inc. is providing enzalutamide. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Writing support for this summary was provided by Maddie Higgins, MBiolSci, and Ama Edusei, PharmD, of CMC Affinity, a division of IPG Health Medical Communications, and was funded by Pfizer.
Acknowledgments
Pfizer and the authors would like to thank all the patients who are participating in this study and their families, as well as the treating physicians, research nurses, study coordinators, and operations staff.
Competing interests disclosure
Full author disclosure information can be found in the original article. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the plain language summary apart from those disclosed in the original published article.