Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging
This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.
• Histologically confirmed high risk prostate adenocarcinoma
• Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \[Ed\].)
• One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must sign institutional review board (IRB) approved study specific informed consent
• Patients must complete all required pre-entry tests
• Patients must be at least 18 years old
• Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)