Trials / Completed
CompletedNCT02737332
A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer
A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Sun Pharmaceutical Industries Limited · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate
Detailed description
This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zytiga® (Abiraterone Acetate) | Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart |
| DRUG | SoluMatrix™ (Abiraterone Acetate) | SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart |
Timeline
- Start date
- 2016-03-21
- Primary completion
- 2017-02-27
- Completion
- 2017-02-27
- First posted
- 2016-04-13
- Last updated
- 2021-11-22
- Results posted
- 2020-08-12
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02737332. Inclusion in this directory is not an endorsement.