Trials / Completed
CompletedNCT02799745
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 227 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
Detailed description
This was a multicenter, randomized, open label exploratory study, conducted in the US and Canada, evaluating the efficacy and safety of enzalutamide for extension of time to prostate cancer progression (pathological or therapeutic) in patients with clinically localized, histologically proven prostate cancer that is categorized as low risk or intermediate risk and who were under AS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | Oral |
| OTHER | Active Surveillance |
Timeline
- Start date
- 2016-06-09
- Primary completion
- 2020-08-28
- Completion
- 2020-08-28
- First posted
- 2016-06-15
- Last updated
- 2024-12-06
- Results posted
- 2021-11-10
Locations
54 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02799745. Inclusion in this directory is not an endorsement.