A Study to Learn More About Darolutamide Compared to Placebo in Addition to Androgen Deprivation Therapy, a Treatment That Lowers Hormones Called Androgens in Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

• Status: Recruiting
• Trial end date: 2025-03-03

Summary

Researchers are looking for a better way to treat men who have non-metastatic castration resistant prostate cancer (nmCRPC). This is a type of cancer in the prostate that has not yet spread to other parts of the body and keeps progressing even when the amount of testosterone (androgen) is reduced to very low levels. Men with nmCRPC usually have higher levels of prostate-specific antigen (PSA) than normal. It is a protein that is made by both normal cells and by cancerous cells in the body. Androgen deprivation therapy (ADT) is a treatment that commonly used to lower the amount of hormones called androgens in the body.

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 hormones, called androgens, from attaching to proteins in cancer cells in the prostate. These hormones are thought to play a role in prostate cancer.

There has been a study to research how patients with nmCRPC benefit with darolutamide plus Androgen deprivation therapy (ADT) as compared to placebo plus ADT therapy before their PSA levels increase but the previous study had no Chinese patients.

Therefore, researchers in this study want to learn how long Chinese men with high risk nmCRPC live before their PSA levels increase. Men with nmCRPC are considered "high risk" if they show signs of quickly increasing PSA levels. This could mean that their cancer will spread to other parts of the body.

The participants in this study will take either darolutamide or a placebo. A placebo looks like a treatment but does not have any medicine in it. All the participants will also take ADT. Doctors are able to prescribe ADT to patients with prostate cancer.

During the study, the participants will take darolutamide or the placebo until:

• their cancer gets worse

• they start another type of cancer treatment

• they have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

• they take another type of medication that is not able to be taken during this study

• they decide to leave the trial

• the participant dies

The participants will visit the study site every 12 weeks during treatment and after stopping treatment. The whole study will last about 35 months. During the study, the doctors will:

• check the participants' overall health and heart health

• take blood samples

• take pictures of the participants' tumors and bones using CT, MRI, and bone scans

• ask the participants questions about how they are feeling, what medications they are taking, and what adverse events they are having.

• Phase: Phase 2

Details

• Lead Sponsor: Bayer
• Treatments: Androgens