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Randomized Phase III Trial Incorporating Abiraterone Acetate With Prednisone and Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy

Protocol No
NRG-GU008-INNOVATE
Principal Investigator
Colleen Lawton
Phase
III
Summary
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
Description
Testing the Addition of the Drugs, Apalutamide and Abiraterone Acetate With Prednisone, to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer (INNOVATE)
Participating Institutions
Froedtert West Bend Hospital
Froedtert Hospital
Froedtert Menomonee Falls Hospital
Status
OPEN TO ACCRUAL