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Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
NCT00838201 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00838201
The ClinicalTrials.gov registry entry for NCT00838201 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00838201 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00838201?
The interventions under investigation include: Denosumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00838201?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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