Placebo of BAY 1841788

DRUG3 trials

Sponsors

Bayer Consumer Care AG, Bayer AG, Ziekenhuis Aan De Stroom

Conditions

Biochemically recurrent prostate cancerMetastatic hormone-sensitive prostate cancer (mHSPC)Prostate cancer

Phase 2

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial

RecruitingCTIS2022-501551-90-00

Ziekenhuis Aan De StroomProstate cancer

Start: 2023-12-13Target: 583Updated: 2026-01-23

Phase 3

(21140 ARANOTE) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

CompletedCTIS2022-502244-12-00

Bayer Consumer Care AG, Bayer AGMetastatic hormone-sensitive prostate cancer (mHSPC)

Start: 2021-02-22End: 2025-11-06Target: 132Updated: 2025-12-01

(21492 ARASTEP) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer

Active, not recruitingCTIS2022-501343-33-00

Bayer Consumer Care AG, Bayer AGBiochemically recurrent prostate cancer

Start: 2023-10-18Target: 562Updated: 2026-01-21