Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer
Public ClinicalTrials.gov record NCT01188187. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.
Study identification
- NCT ID
- NCT01188187
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,022 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Jan 31, 2014
- Completion
- May 31, 2014
- Last update posted
- Oct 13, 2016
2010 – 2014
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 100 | Birmingham | Alabama | — | — |
| Teva Investigational Site 086 | Los Angeles | California | — | — |
| Teva Investigational Site 263 | Los Angeles | California | — | — |
| Teva Investigational Site 093 | Marina del Rey | California | — | — |
| Teva Investigational Site 097 | San Diego | California | — | — |
| Teva Investigational Site 090 | Fort Collins | Colorado | — | — |
| Teva Investigational Site 106 | Fort Myers | Florida | — | — |
| Teva Investigational Site 094 | Port Saint Lucie | Florida | — | — |
| Teva Investigational Site 096 | Atlanta | Georgia | — | — |
| Teva Investigational Site 103 | Baton Rough | Louisiana | — | — |
| Teva Investigational Site 098 | Ann Arbor | Michigan | — | — |
| Teva Investigational Site 112 | Detroit | Michigan | — | — |
| Teva Investigational Site 032 | Rochester | Minnesota | — | — |
| Teva Investigational Site 204 | Las Vegas | Nevada | — | — |
| Teva Investigational Site 107 | Cincinnati | Ohio | — | — |
| Teva Investigational Site 266 | Greensboro | South Carolina | — | — |
| Teva Investigational Site 102 | Myrtle Beach | South Carolina | — | — |
| Teva Investigational Site 084 | Memphis | Tennessee | — | — |
| Teva Investigational Site 101 | Nashville | Tennessee | — | — |
| Teva Investigational Site 116 | San Antonio | Texas | — | — |
| Teva Investigational Site 059 | Tyler | Texas | — | — |
| Teva Investigational Site 063 | Tyler | Texas | — | — |
| Teva Investigational Site 047 | Newport | Virginia | — | — |
| Teva Investigational Site 104 | Norfolk | Virginia | — | — |
| Teva Investigational Site 029 | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 115 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01188187, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01188187 live on ClinicalTrials.gov.