# ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

> **NCT04916613** · PHASE3 · RECRUITING · sponsor: **UNICANCER** · enrollment: 300 (estimated)

## Conditions studied

- Prostate Cancer Metastatic

## Interventions

- **DRUG:** Darolutamide 300 mg
- **DRUG:** Placebo
- **DRUG:** Androgen deprivation therapy

## Key facts

- **NCT ID:** NCT04916613
- **Lead sponsor:** UNICANCER
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-04-19
- **Primary completion:** 2028-03
- **Final completion:** 2037-09
- **Target enrollment:** 300 (ESTIMATED)
- **Last updated:** 2026-04-28

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04916613

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04916613, "ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04916613. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
