Trials / Terminated
TerminatedNCT02758132
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University of Hawaii · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity. |
| DRUG | Enzalutamide | 160 mg enzalutamide by mouth daily |
| DRUG | Abiraterone | 1000 mg abiraterone by mouth daily |
| DRUG | Prednisone | 5 mg prednisone by mouth twice daily |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-09-06
- Completion
- 2016-09-06
- First posted
- 2016-05-02
- Last updated
- 2019-11-08
- Results posted
- 2019-10-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02758132. Inclusion in this directory is not an endorsement.