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COMPLETED Phase 1

Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer

NCT02012296 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 88 participants
Start Date 2013-12-13
Est. Completion 2020-08-01
Phase Phase 1

Sponsor

University of Chicago

846 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02012296

The ClinicalTrials.gov registry entry for NCT02012296 describes a study currently listed as completed. It is categorized as Phase 1, 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 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 846 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT02012296 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Michigan. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02012296?

The interventions under investigation include: laboratory biomarker analysis (OTHER), enzalutamide (DRUG), pharmacological study (OTHER), mifepristone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02012296?

This trial is sponsored by University of Chicago, which has 846 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial