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Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel

NCT02491411 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-07-12

Study results available
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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.

Conditions

  • Hormone-Resistant Prostate Cancer
  • Metastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Stage IV Prostate Cancer

Interventions

DRUG

Dexamethasone

Given PO

DRUG

Enzalutamide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Samuel Denmeade · Johns Hopkins University/Sidney Kimmel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491411 on ClinicalTrials.gov