Darolutamide (BAY 1841788)

DRUG4 trials

Sponsors

Bayer, Canadian Cancer Trials Group, Peking University First Hospital

Conditions

Metastatic Hormone-Sensitive Prostate CancerNon-metastatic Castration-resistant Prostate CancerProstate CancerProstate Cancer (Adenocarcinoma)

Phase 2

Darolutamide+ADT Post-RP w/o ePLND in hrPC: Briganti 2019

Not yet recruitingNCT07282197

Peking University First HospitalProstate Cancer

Start: 2026-01-31End: 2029-06-30Target: 40Updated: 2025-12-15

Phase 3

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

RecruitingNCT06592924

Canadian Cancer Trials GroupProstate Cancer (Adenocarcinoma)

Start: 2025-05-28End: 2031-04-15Target: 830Updated: 2026-07-14

Unknown Phase

An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

CompletedNCT06013475

BayerNon-metastatic Castration-resistant Prostate Cancer

Start: 2023-08-31End: 2024-10-28Updated: 2025-06-12

A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

Active, not recruitingNCT07344779

BayerMetastatic Hormone-Sensitive Prostate Cancer

Start: 2026-01-29End: 2030-06-30Target: 1600Updated: 2026-07-07

Related Papers

Real-world analysis of androgen receptor inhibitors in US patients with nonmetastatic castration-resistant prostate cancer: DEAR-EXT study.

2026-03-18

TRIPLE-SWITCH (SWOG/CCTG-PR26): A randomized phase III clinical trial for the addition of docetaxel to androgen receptor pathway inhibitors in patients with metastatic castration sensitive prostate cancer (mCSPC) and suboptimal PSA response (NCT06592924).

Journal of Clinical Oncology2025-05-282 citations

Real-world use and outcomes of darolutamide (DARO), enzalutamide (ENZA), and apalutamide (APA) for nonmetastatic castration-resistant prostate cancer (nmCRPC): Race subgroup analysis.

Journal of Clinical Oncology2025-02-10

US real-world utilization and outcomes of darolutamide, enzalutamide, and apalutamide for nonmetastatic castration-resistant prostate cancer (nmCRPC): DEAR-EXT study.

JCO Oncology Practice2024-09-301 citations