Nrg-Gu008 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
Posted Date: Jul 6, 2021
- Investigator: Abhinav Sidana
- Specialties: Cancer, Oncology, Prostate Cancer
- Type of Study: Drug
The primary purpose of this study is to determine how well adding apalutamide, abiraterone acetate, and prednisone to the usual hormone therapy and radiation therapy works compared to the usual hormone therapy and radiation therapy in treating patients with node-positive prostate cancer after surgery. Efficacy will be measured by comparing metastasis-free survival (MFS) of salvage radiation therapy and gonadotropin releasing hormone agonist/antagonist versus RT/GnRH agonist/antagonist with abiraterone acetate with prednisone and apalutamide for patients with pathologic node-positive prostate cancer after radical prostatectomy with detectable prostate-specific antigen. Patients in arm 1 will receive hormone therapy and radiation therapy. Patients in arm 2 will receive apalutamide, abiraterone acetate, prednisone as well as hormone therapy and radiation therapy.
Participants Must Have Pathologically Proven Diagnosis Of Prostate Adenocarcinoma. Pathologically Node Positive Disease With Nodal Involvement Only In The Pelvis In The Prostatectomy Specimen. Ecog Performance Status Of 0-1 Within 90 Days Prior To Registration. Detectable Psa (Serum Psa > 0 Ng/Ml) After Radical Prostatectomy. Hemoglobin >= 9.0 G/Dl. Platelet Count >= 100,000 X 10^9/Ul. Serum Potassium >= 3.5 Mmol/L . Creatinine Clearance (Crcl) >= 30 Ml/Min. Total Bilirubin =< 1.5 X Institutional Upper Limit Of Normal. Serum Albumin >= 3.0 G/Dl. No Definitive Radiologic Evidence Of Metastatic Disease. No Prior Systemic Chemotherapy For The Study Cancer. No Current Use Of 5-Alpha Reductase Inhibitor. No Didanosine (Ddi) Antiretroviral Therapy.
Prostate Cancer, Phase 3
For More Information:
Uc Cancer Center