# 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.

> **NCT05059236** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Bayer** · enrollment: 223 (actual)

## Conditions studied

- Metastatic Hormone-sensitive Prostate Cancer

## Interventions

- **DRUG:** Darolutamide (BAY1841788, Nubeqa)
- **OTHER:** ADT

## Key facts

- **NCT ID:** NCT05059236
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-11-04
- **Primary completion:** 2025-05-30
- **Final completion:** 2026-06-05
- **Target enrollment:** 223 (ACTUAL)
- **Last updated:** 2026-05-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05059236

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05059236, "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.". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05059236. Licensed CC0.

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