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Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

NCT02278185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-05-11

Study results available
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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.

Conditions

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

DRUG

Enzalutamide

Given PO

DRUG

leuprolide acetate

Given SC or IM

DRUG

goserelin acetate

Given SC or IM

DRUG

histrelin acetate

Given SC or IM

DRUG

triptorelin

Given SC or IM

DRUG

degarelix

Given SC or IM

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Elizabeth Kessler, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-11
Primary Completion
2019-04-10
Completion
2024-07-18

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 NCT02278185 on ClinicalTrials.gov