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NCT02491411 · ClinicalTrials.gov registry record · NA
Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT02491411: Clinical Trial NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02491411 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02491411, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in treating patients with prostate cancer that has spread to other places in the body (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously treated with enzalutamide and docetaxel. Dexamethasone treatment may be able to reverse one resistance mechanism to enzalutamide therapy (overabundance of receptors for dexamethasone and other glucocorticoids inside cancer cells) and allow for renewed therapeutic sensitivity to enzalutamide. Androgens (a type of male hormone) can bind to androgen receptors found inside prostate cancer cells, which may cause the cancer cells to grow. Enzalutamide may stop the growth of prostate cancer cells by blocking the activity of the cancer cell androgen receptors. Giving dexamethasone prior to re-treatment with enzalutamide may be a treatment for prostate cancer.
Primary Outcome
PSA response rate is defined as the proportion of subjects with a \>= 50% PSA decline from baseline level when starting enzalutamide and maintained for \>= 4 weeks at any time-point after receiving enzalutamide. Will determine its corresponding 95% confidence interval.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-03 |
| Phase | NA |
Why NCT02491411 stopped before completion
NCT02491411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02491411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02491411 about?
NCT02491411 is a clinical study titled "Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel". This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in treating patients with prostate cancer that has spread to other places in the body (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously treated with enzalutamide and doceta...
What is the current status of trial NCT02491411?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2015-09. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02491411?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02491411?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02491411's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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