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NCT04157088 · ClinicalTrials.gov registry record · Phase 2
Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT04157088: Clinical Trial Phase 2 study, sponsored by Bayer.
NCT04157088 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157088, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
Primary Outcome
TUG: Timed Up \& Go. Worsening is defined as an increase of at least 1 second in TUG time from baseline. (The minimum clinically important difference \[MCID\] in TUG time is 1 second
Interventions
- DRUG Enzalutamide
- DRUG Darolutamide (Nubeqa, BAY1841788)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 2 |
Why NCT04157088 stopped before completion
NCT04157088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT04157088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04157088 about?
NCT04157088 is a clinical study titled "Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)". Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatm...
What is the current status of trial NCT04157088?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-12-17. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT04157088?
The interventions under investigation include: Enzalutamide (DRUG), Darolutamide (Nubeqa, BAY1841788) (DRUG).
Who is sponsoring clinical trial NCT04157088?
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 NCT04157088's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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