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NCT00838201 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
A Phase 3 study of Prostate Cancer and Cancer, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 384
- Enrollment target
- 20
- Study locations
NCT00838201: Completed Phase 3 study of Prostate Cancer and Cancer, sponsored by Amgen.
NCT00838201 is a Phase 3 study of Prostate Cancer and Cancer that has completed, run by Amgen. The registered enrollment target is 384 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00838201, a Phase 3 study of Prostate Cancer and Cancer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 384 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.
Conditions Studied
Interventions
- DRUG Denosumab
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Laguna Hills
- Research Site - Long Beach
- Research Site - San Bernardino
- Research Site - San Diego
- Research Site - San Diego
- Research Site - Santa Monica
New York
- Research Site - Albany
- Research Site - Bay Shore
- Research Site - Garden City
- Research Site - Poughkeepsie
Connecticut
- Research Site - Middlebury
- Research Site - New Britain
Alabama
- Research Site - Huntsville
Florida
- Research Site - Trinity
Indiana
- Research Site - Fort Wayne
Maryland
- Research Site - Greenbelt
Minnesota
- Research Site - Sartell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2009-02-01 |
| Est. Completion | 2012-05-03 |
| Phase | Phase 3 |
What the finished NCT00838201 record still lists
NCT00838201 is an interventional study that assigns participants to a tested intervention. The registered 384 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 (37% lower).
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.
NCT00838201 names 20 study sites across 10 states, led by California, New York, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00838201 about?
NCT00838201 is a clinical study titled "Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer". The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received de...
What is the current status of trial NCT00838201?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2009-02-01. Estimated completion is 2012-05-03.
What conditions does trial NCT00838201 study?
This clinical trial studies the following conditions: Prostate Cancer, Cancer, Carcinoma, Tumors, Castrate Resistant Prostate Cancer.
What interventions are being tested in trial NCT00838201?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT00838201?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00838201 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00838201's enrollment target sits among peer trials
384 140th of 735 higher than 596 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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