Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (37% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
-
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
RECRUITING · Phase 3
-
PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
RECRUITING · Phase 3
-
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
RECRUITING · Phase 3
-
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
RECRUITING · Phase 3
-
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
RECRUITING · Phase 3
-
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.