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NCT02012296 · ClinicalTrials.gov registry record · Phase 1
Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer
A Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 4
- Study locations
NCT02012296: Completed Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by University of Chicago.
NCT02012296 is a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer that has completed, run by University of Chicago. The registered enrollment target is 88 participants, below the 135-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (35% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02012296, a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 4
- Study locations
Study Summary
This partially randomized phase I/II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is more effective with or without mifepristone in treating patients with prostate cancer.
Primary Outcome
PSA progression was defined as a PSA that is ≥1.25 times (25% increase) the PSA at randomization (week 12) and an absolute 5 ng/ml increase. PSA progression-free survival is PSA progression or death from any cause.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG enzalutamide
- OTHER pharmacological study
- DRUG mifepristone
Study Locations (4)
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- Cancer Care Specialists of Central Illinois (Decatur) /Decatur Memorial Hospital - Decatur
- NorthShore University Health System - Evanston
Michigan
- Wayne State University Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2020-08-01 |
| Phase | Phase 1 |
What the finished NCT02012296 record still lists
NCT02012296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 135-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (35% lower).
The record links to 3 conditions, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT02012296 reports a single indexed study location in Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT02012296 about?
NCT02012296 is a clinical study titled "Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer". This partially randomized phase I/II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antiho...
What is the current status of trial NCT02012296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2013-12-13. Estimated completion is 2020-08-01.
What conditions does trial NCT02012296 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer, Stage IV Prostate Cancer, Hormone-Resistant Prostate Cancer.
What interventions are being tested in trial NCT02012296?
The interventions under investigation include: laboratory biomarker analysis (OTHER), enzalutamide (DRUG), pharmacological study (OTHER), mifepristone (DRUG).
Who is sponsoring clinical trial NCT02012296?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02012296 being conducted?
This trial has 4 study locations across Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent 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 NCT02012296's enrollment target sits among peer trials
88 6th of 21 higher than 16 of 21 other Recurrent Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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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