drugset / Trial / NCT02508636

Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

NCT02508636

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the safety of giving enzalutamide with leuprolide acetate before and after radiation therapy and to see how well it works in treating patients with prostate cancer that is at high risk of returning. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Most types of prostate cancer also need testosterone to grow and spread. After radiation therapy, patients often receive treatments to reduce testosterone to prevent the cancer from returning. Leuprolide acetate works by reducing the amount of testosterone that the body makes. Enzalutamide is a stronger treatment that may block testosterone from reaching cancer cells. Adding enzalutamide to treatment with leuprolide acetate after radiation therapy may help prevent high-risk prostate cancer from returning and improve patient survival.

Timeline

Start
2015-12-22
Primary completion
2020-08-31
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg Oral
Subject Leuprolide Other / unclassified 7.5 mg Intramuscular
Subject Leuprolide Other / unclassified 22.5 mg Intramuscular
Subject Leuprolide Other / unclassified 30 mg Intramuscular
Subject Leuprolide Other / unclassified 45 mg Intramuscular