A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

Summary

The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival. The researchers want to learn how long it takes for the cancer to get worse (also known as "progression-free survival") by either increasing symptoms, new metastases, PSA rise or death. All participants will be on treatment and take darolutamide with ADT until their cancer spreads, they have a medical problem, or they leave the study. The results will then be compared with patients' results from another study who received ADT alone (CHAARTED). This study will also assess safety by gathering adverse event information throughout the duration of the study. An adverse event is any medical problem, related or not to study treatment that a participant has during a study. The study drug, is already available for doctors to prescribe to patients with prostate cancer, including those with metastatic disease as well as those whose cancer has not yet spread to other parts of the body. The study drug, darolutamide, works by blocking a protein called a receptor from attaching to a hormone called androgen that is found in men. This protein can also be found in prostate cancer cells. ADT is a treatment that doctors are currently able to prescribe to patients with mHSPC. ADT is used to lower the amount of the androgen hormone. Darolutamide is approved for use with ADT, with or without docetaxel, in patients with mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease.

Timeline

Start

2021-11-04

Primary completion

2025-05-30

Completion

2026-06-15

Publications

• McKay RR, Ross AE, Preston MA, Gregg JR, Salami SS, Littleton N, Constantinovici N, Srinivasan S, Verholen F, Shore ND. Darolutamide plus androgen-deprivation therapy: propensity score matching of ARASEC and historic clinical trial patients. Future Oncol. 2025 May;21(11):1365-1375. doi: 10.1080/14796694.2025.2482360. Epub 2025 Apr 1.

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