(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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502244-12-00

Acronym

21140

Enrollment

132

Registered

2023-05-20

Start date

2021-02-22

Completion date

2025-11-06

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic hormone-sensitive prostate cancer (mHSPC)

Brief summary

Radiological progression-free survival

Detailed description

Overall survival (OS), Time to castration–resistant prostate cancer (CRPC), Time to initiation of subsequent anti-cancer therapy, Time to PSA progression, Percentage of participants with detectable PSA values (≥0.2 ng/mL) at baseline which become undetectable (<0.2 ng/mL), Time to pain progression, Number of participants with treatment emergent adverse events

Interventions

DRUG-

DRUGBAY 1841788

DRUGPlacebo of BAY 1841788

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiological progression-free survival	—

Secondary

Measure	Time frame
Overall survival (OS), Time to castration–resistant prostate cancer (CRPC), Time to initiation of subsequent anti-cancer therapy, Time to PSA progression, Percentage of participants with detectable PSA values (≥0.2 ng/mL) at baseline which become undetectable (<0.2 ng/mL), Time to pain progression, Number of participants with treatment emergent adverse events	—

Countries

Latvia, Lithuania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026