Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
Public ClinicalTrials.gov record NCT01578655. 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 Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
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 cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
Study identification
- NCT ID
- NCT01578655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 630 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Aug 2012 (Type not available)
- Primary completion
- Jul 2016 (Actual)
- Completion
- Jul 2016 (Actual)
- Last update posted
- Oct 12, 2016
2012 – 2016
United States locations
- U.S. sites
- 35
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prostate Oncology Specialists | Marina del Rey | California | — | — |
| University of California Davis Medical Center | Sacramento | California | — | — |
| Sharp Health Care | San Diego | California | — | — |
| California Pacific Medical Center Research Institute | San Francisco | California | — | — |
| Rocky Mountain Cancer Center | Boulder | Colorado | — | — |
| Hartford Hospital | Hartford | Connecticut | — | — |
| Smilow Cancer Hospital at Yale New Haven Hospital | New Haven | Connecticut | — | — |
| The Center for Hematology-Oncology | Boca Raton | Florida | — | — |
| Florida Cancer Specialists | Fort Myers | Florida | — | — |
| Florida Cancer Specialists | Inverness | Florida | — | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | — | — |
| Georgia Cancer Specialists, P.C. | Marietta | Georgia | — | — |
| Cancer Center of Kansas | Wichita | Kansas | — | — |
| Boston University Medical Center | Boston | Massachusetts | — | — |
| University of Michigan Health System | Ann Arbor | Michigan | — | — |
| Karmanos Cancer Institute | Detroit | Michigan | — | — |
| Washington University School of Medicine | St Louis | Missouri | — | — |
| Urology Cancer Center and GU Research Network | Omaha | Nebraska | — | — |
| Monter Cancer Center | Lake Success | New York | — | — |
| SUNY Upstate Medical University | Syracuse | New York | — | — |
| Albert Einstein Medical Center | The Bronx | New York | — | — |
| Blumenthal Cancer Center | Charlotte | North Carolina | — | — |
| Cancer Centers of North Carolina | Raleigh | North Carolina | — | — |
| Oncology Hematology Care, Inc. | Blue Ash | Ohio | — | — |
| The Mark H. Zangmeister Center | Columbus | Ohio | — | — |
| Oregon Health and Science University | Portland | Oregon | — | — |
| South Carolina Oncology Associates | Columbia | South Carolina | — | — |
| Cancer Centers of the Carolinas | Greenville | South Carolina | — | — |
| Chattanooga Oncology and Hematology Associates | Chattanooga | Tennessee | — | — |
| The West Clinic | Memphis | Tennessee | — | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | — | — |
| Texas Oncology, PA | Dallas | Texas | — | — |
| Utah Cancer Specialists | Salt Lake City | Utah | — | — |
| Virginia Oncology Associates | Norfolk | Virginia | — | — |
| Virginia Cancer Institute | Richmond | Virginia | — | — |
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 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01578655, 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 12, 2016 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01578655 live on ClinicalTrials.gov.