Trials / Completed
CompletedNCT01809691
S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,313 (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-700 | 300 mg, PO, twice daily |
| DRUG | Bicalutamide | 50 mg, PO, q daily |
Timeline
- Start date
- 2013-03-08
- Primary completion
- 2022-03-08
- Completion
- 2025-09-09
- First posted
- 2013-03-13
- Last updated
- 2025-12-31
- Results posted
- 2022-09-08
Locations
560 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01809691. Inclusion in this directory is not an endorsement.