drugset / Trial / NCT03279250

Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer

NCT03279250

Phase 2 Completed 86 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.

Timeline

Start
2017-10-13
Primary completion
2021-05-11
Completion
2021-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Subject Apalutamide Small molecule 240 mg Oral
Subject Goserelin Other / unclassified Intramuscular
Subject Leuprolide Other / unclassified Intramuscular
Subject Prednisone Other / unclassified 5 mg Oral
Subject Triptorelin Other / unclassified Intramuscular