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NCT02799602 · ClinicalTrials.gov registry record · Phase 3
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,306
- Enrollment target
NCT02799602: Completed Phase 3 study, sponsored by Bayer.
NCT02799602 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,306 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02799602, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,306 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Primary Outcome
Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period f
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG BAY1841788 / darolutamide (ODM-201)
- DRUG Standard ADT (androgen deprivation therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,306 participants |
| Start Date | 2016-11-30 |
| Est. Completion | 2023-04-11 |
| Phase | Phase 3 |
What the finished NCT02799602 record still lists
NCT02799602 is an interventional study that assigns participants to a tested intervention. Its 1,306 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02799602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02799602 about?
NCT02799602 is a clinical study titled "Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer". The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
What is the current status of trial NCT02799602?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,306 participants. The study started on 2016-11-30. Estimated completion is 2023-04-11.
What interventions are being tested in trial NCT02799602?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), BAY1841788 / darolutamide (ODM-201) (DRUG), Standard ADT (androgen deprivation therapy) (DRUG).
Who is sponsoring clinical trial NCT02799602?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02799602's enrollment target sits among peer trials
1,306 188th of 2000 higher than 1,813 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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