Darolutamide (BAY1841788, Nubeqa)

DRUG2 trials

Sponsors

Bayer

Conditions

Biochemically Recurrent Prostate CancerMetastatic Hormone-sensitive Prostate Cancer

Phase 2

A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

CompletedNCT05059236

BayerMetastatic Hormone-sensitive Prostate Cancer

Start: 2021-11-04End: 2026-06-15Updated: 2026-09-15

Phase 3

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Active, not recruitingNCT05794906

BayerBiochemically Recurrent Prostate Cancer

Start: 2023-04-03End: 2030-03-29Updated: 2026-07-07

Related Papers

Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP).

2025-11-11

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

Journal of Clinical Oncology2025-05-281 citations

Darolutamide plus androgen-deprivation therapy: propensity score matching of ARASEC and historic clinical trial patients

Future Oncology2025-04-01

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

Journal of Clinical Oncology2025-02-10

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

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

Journal of Clinical Oncology2024-01-292 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

Open-label study of darolutamide plus androgen-deprivation therapy (ADT) vs ADT in metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC).

Journal of Clinical Oncology2023-06-01

Darolutamide plus androgen-deprivation therapy (ADT) versus ADT in metastatic hormone-sensitive prostate cancer: Open-label single-arm study with an external control arm (ARASEC).

Journal of Clinical Oncology2023-02-202 citations

Open-label study of androgen receptor inhibition with darolutamide plus androgen-deprivation therapy (ADT) versus ADT in men with metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC).

Journal of Clinical Oncology2022-06-01