drugset / Trial / NCT02278185

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

NCT02278185

Phase 2 Completed 19 enrolled University of Colorado, Denver
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Degarelix Other / unclassified Subcutaneous
Subject Enzalutamide Other / unclassified Oral
Comparator Goserelin Other / unclassified Subcutaneous
Comparator Histrelin Other / unclassified Subcutaneous
Comparator Leuprolide Other / unclassified Subcutaneous
Comparator Triptorelin Other / unclassified Subcutaneous