Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score

Location: Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Purpose:

 This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding abiraterone acetate and apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Sponsor: NRG Oncology

https://clinicaltrials.gov/ct2/show/NCT04513717

Eligibility:

• Diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration, high-risk disease 
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere 
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. 
• No evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) 
• No prior systemic chemotherapy within =< 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed if completed > 3 years prior to registration
• No prior radical prostatectomy
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• No history any of the following: Seizure disorder, current severe or unstable angina classification III/IV, or any condition that in the opinion of the investigator would preclude participation in this study
• No evidence of any of the following:  Active uncontrolled infection requiring IV antibiotics, Baseline moderate and severe hepatic impairment, Inability to swallow oral pills, or any current condition that in the opinion of the investigator, would preclude participation in this study

Time Commitment: Lifetime