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Clinical Trial 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, darolutamide, is already available for doctors to prescribe to patients with prostate cancer that has not yet spread to other parts of the body. It 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05059236
Study type Interventional
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 30, 2021
Completion date February 5, 2026

See also
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Active, not recruiting NCT00309985 - Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Phase 3
Withdrawn NCT03343977 - Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Phase 1/Phase 2
Active, not recruiting NCT04191096 - Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Phase 3
Active, not recruiting NCT03879122 - A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer Phase 2/Phase 3