# 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

> **NCT05794906** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Bayer** · enrollment: 985 (actual)

## Conditions studied

- Biochemically Recurrent Prostate Cancer

## Interventions

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

## Key facts

- **NCT ID:** NCT05794906
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-04-03
- **Primary completion:** 2027-07-30
- **Final completion:** 2030-03-29
- **Target enrollment:** 985 (ACTUAL)
- **Last updated:** 2026-04-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05794906

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05794906, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05794906. Licensed CC0.

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