Darolutamide (Nubeqa, BAY1841788)

DRUG9 trials

Sponsors

Bayer

Conditions

CancerCastration-ResistantMetastatic Hormone-sensitive Prostate CancerNon-metastatic Castration-resistant Prostate CancerNon-metastatic Prostate CancerProstate CancerProstate Cancer Non-MetastaticProstatic Cancer, Castration-Resistant

Phase 2

Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

TerminatedNCT04157088

BayerProstatic Cancer, Castration-Resistant

Start: 2019-12-17End: 2022-07-08Updated: 2023-08-04

Phase 3

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

CompletedNCT02200614

BayerCastration-Resistant, Prostate Cancer Non-Metastatic

Start: 2014-09-12End: 2021-06-14Updated: 2022-06-28

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Active, not recruitingNCT04464226

Start: 2020-10-20End: 2028-06-26Target: 402Updated: 2026-07-07

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

CompletedNCT04736199

BayerProstatic Neoplasms

Start: 2021-02-23End: 2026-01-23Updated: 2026-02-27

Phase 4

A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

RecruitingNCT05348876

BayerNon-metastatic Castration-resistant Prostate Cancer

Start: 2022-08-03End: 2027-04-29Target: 50Updated: 2026-07-06

Unknown Phase

A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

CompletedNCT05202301

BayerProstate Cancer

Start: 2022-01-15End: 2025-07-15Updated: 2025-08-11

An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

CompletedNCT05362149

BayerNon-metastatic Castration-resistant Prostate Cancer

Start: 2022-04-04End: 2023-06-30Updated: 2024-03-20

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

CompletedNCT06204302

BayerNon-metastatic Castration-resistant Prostate Cancer, Non-metastatic Prostate Cancer

Start: 2024-01-05End: 2024-04-04Updated: 2024-04-09

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

RecruitingNCT06334120

BayerMetastatic Hormone-sensitive Prostate Cancer, Non-metastatic Castration-resistant Prostate Cancer

Start: 2024-09-25End: 2028-06-30Target: 600Updated: 2026-08-26

Related Papers

Prostate-specific antigen outcomes of darolutamide and androgen deprivation therapy in patient subgroups by age, comorbidities, and concomitant medications: ARANOTE post hoc analyses.

Journal of Clinical Oncology2026-05-27

Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.

2026-01-011 citations

A Deep Prostate-specific Antigen Response to Darolutamide plus Androgen Deprivation Therapy Is Associated with Better Clinical Outcomes in the Phase 3 ARANOTE Trial in Patients with Metastatic Hormone-sensitive Prostate Cancer.

2025-08-22

Matching-adjusted indirect comparison of enzalutamide versus darolutamide doublet in mHSPC.

2025-07-14

Functional assessment in patients with castration-resistant prostate cancer treated with darolutamide: results from the DaroAcT study.

2025-07-01

Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial.

Journal of Clinical Oncology2025-05-281 citations

Development and validation of a machine learning-based risk model for metastatic disease in nmCRPC patients: a tumor marker prognostic study

International Journal of Surgery2025-03-263 citations

Lower Testosterone Level and Metastases-Free Survival in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Novel Antiandrogens: A Post Hoc Analysis of SPARTAN and ARAMIS

The Journal of Urology2025-03-251 citations

Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: Subgroup analysis of the phase 3 ARANOTE trial.

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

Abstract C162: Prespecified interim analysis of the DARolutamide ObservationaL (DAROL) study in Black/African American patients with nonmetastatic castration-resistant prostate cancer (nmCRPC)

Cancer Epidemiology Biomarkers & Prevention2024-09-21

Darolutamide plus androgen-deprivation therapy in patients with high-risk biochemical recurrence of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP).

Journal of Clinical Oncology2024-06-01

Association between prostate-specific antigen (PSA) level <0.2 ng/mL and risk of radiological progression in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC): Follow-up analysis of ARAMIS.

Journal of Clinical Oncology2024-06-01

PD01-03 THIRD INTERIM ANALYSIS (IA3) OF THE DAROLUTAMIDE OBSERVATIONAL (DAROL) STUDY IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC)

The Journal of Urology2024-04-15

Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS

The Oncologist2024-02-235 citations

ARAMON: A phase 2, randomized, open-label study comparing darolutamide (DARO) vs enzalutamide (ENZA) monotherapy on serum testosterone levels in patients (pts) with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR).

Journal of Clinical Oncology2024-01-291 citations

Effect of crossover from placebo to darolutamide on overall survival in men with non-metastatic prostate cancer: sensitivity analyses from the randomised phase 3 ARAMIS study.

2023-09-17

Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial.

2023-07-2710 citations

Darolutamide observational (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: Second interim analysis.

Journal of Clinical Oncology2023-06-011 citations

A phase 2, randomized, open-label study comparing the effects of darolutamide versus enzalutamide monotherapy on serum testosterone levels in patients with hormone-naive prostate cancer: ARAMON study.

Journal of Clinical Oncology2023-06-01

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