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NCT02278185 · ClinicalTrials.gov registry record · Phase 2
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT02278185: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT02278185 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02278185, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.
Primary Outcome
Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference \> 102 cm (\> 40 in); serum triglycerides \>= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum high density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure \>= 130/\>= 85 mmHg or drug treatment for elevated blood pressure; and fasting plasm
Interventions
- DRUG Enzalutamide
- DRUG leuprolide acetate
- DRUG goserelin acetate
- DRUG triptorelin
- DRUG histrelin acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-11-11 |
| Est. Completion | 2024-07-18 |
| Phase | Phase 2 |
What the finished NCT02278185 record still lists
NCT02278185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Enzalutamide is the first listed.
NCT02278185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02278185 about?
NCT02278185 is a clinical study titled "Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer". This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulati...
What is the current status of trial NCT02278185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2015-11-11. Estimated completion is 2024-07-18.
What interventions are being tested in trial NCT02278185?
The interventions under investigation include: Enzalutamide (DRUG), leuprolide acetate (DRUG), goserelin acetate (DRUG), triptorelin (DRUG), histrelin acetate (DRUG).
Who is sponsoring clinical trial NCT02278185?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02278185's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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