NCT05171387

Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer

A Single-arm, Open-label Phase 2 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) in Chinese Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are seeking better ways to treat men who have non-metastatic castration resistant prostate cancer (nmCRPC). This type of prostate cancer-nmCRPC- is one that has not spread to other parts of the body yet keeps progressing despite low levels of (the hormone) testosterone. Signs of cancer progression are detected by higher (blood) levels of a protein known as "prostate-specific antigen" (PSA). PSA is made by both normal and cancerous cells in the body. An established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body is known as "Androgen deprivation therapy" (ADT), and all study participants will receive this (if they have not had surgery to remove their testicles). All participants will also receive the study-drug, darolutamide, which is already available for doctors to prescribe to patients with this condition. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. There has been a previous research study that showed that patients with nmCRPC benefit from the combination of darolutamide plus Androgen deprivation therapy (ADT) when compared with placebo plus ADT therapy. Participants from mainland China were not included in the previous study. The present study focuses specifically on Chinese participants with nmCRPC, who will receive both medications- darolutamide plus ADT. Researchers will be using a "marker" of cancer- PSA- to look at how the PSA declines when participants take study treatment. By using the tumor marker PSA, researchers can more quickly identify how study participants are responding to their study treatment. All the participants will also take ADT. During the study, participants will take darolutamide until: (1) their cancer spreads (2) they start another type of cancer treatment (3) they have an adverse event that requires stopping the medication. 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 is related to the study treatments. Other reasons for study discontinuation include: (4) a participant takes another type of medication that is not permitted to be taken during this study (5) the patient chooses to leave the trial or (6) the participant dies. Study participants will visit the study site every 12 weeks for the first 3 visits and after visit 3, visit interval will be every 16 weeks during treatment and after stopping treatment (participants may continue to be followed even after stopping treatment). It is anticipated that the whole study will last about 35 months. During the study, doctors will: (1) check the participants' overall health and heart health (2) take blood samples (3) take pictures of the participants' tumors and bones using CT, MRI, and bone scans and (4) ask the participants questions about how they are feeling, what medications they are taking, and about adverse events they might be having.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide 600 mg twice daily	The participants will take 2 tablets (300 mg each tablet) of study treatment (darolutamide) orally bid at about 12 hour intervals.
DRUG	Androgen deprivation therapy (ADT)	Androgen deprivation therapy (ADT) is a treatment that commonly used to lower the amount of hormones called androgens in the body.

Timeline

• Start date: 2021-11-30
• Primary completion: 2024-12-04
• Completion: 2025-02-24
• First posted: 2021-12-28
• Last updated: 2025-06-22

Locations

1 site across 1 country: China