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NCT01314118 · ClinicalTrials.gov registry record · Phase 2
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
A Phase 2 study of Prostate Cancer and Prostatic Neoplasm, sponsored by Janssen Biotech.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT01314118: Completed Phase 2 study of Prostate Cancer and Prostatic Neoplasm, sponsored by Janssen Biotech.
NCT01314118 is a Phase 2 study of Prostate Cancer and Prostatic Neoplasm that has completed, run by Janssen Biotech. The registered enrollment target is 131 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314118, a Phase 2 study of Prostate Cancer and Prostatic Neoplasm, has completed, sponsored by Janssen Biotech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.
Primary Outcome
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Conditions Studied
Interventions
- DRUG abiraterone acetate in combination with prednisone
Study Locations (20)
Illinois
- - Evanston
- - Galesburg
- - Glenview
- - Melrose Park
California
- - Los Angeles
- - San Diego
- - San Francisco
Alabama
- - Homewood
- - Huntsville
Colorado
- - Aurora
- - Denver
Florida
- - Aventura
- - Orange City
Indiana
- - Fort Wayne
- - Jeffersonville
Maryland
- - Baltimore
- - Rockville
Arizona
- - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2011-05-04 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 2 |
What the finished NCT01314118 record still lists
NCT01314118 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which abiraterone acetate in combination with prednisone is the first listed.
NCT01314118 names 20 study sites across 10 states, led by Illinois, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01314118 about?
NCT01314118 is a clinical study titled "IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen". The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information a...
What is the current status of trial NCT01314118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2011-05-04. Estimated completion is 2024-12-02.
What conditions does trial NCT01314118 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostatic Neoplasm.
What interventions are being tested in trial NCT01314118?
The interventions under investigation include: abiraterone acetate in combination with prednisone (DRUG).
Who is sponsoring clinical trial NCT01314118?
This trial is sponsored by Janssen Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01314118 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01314118's enrollment target sits among peer trials
131 290th of 735 higher than 445 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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