A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
The purpose of this prostate cancer research study is to learn about: 1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy; 2. Preserving quality of life after radiation therapy; 3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
• Histologically proven prostate adenocarcinoma
• Male, ≥ 18 years old
• Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
‣ a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) \> liver uptake and CT scan correlate)
⁃ b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
⁃ c. At least one lesion in the sub-diaphragmatic para-aortic lymph nodes
⁃ d. Non-bulky nodal disease (ie, tumor \<5 cm)
• Prior pelvic radiation with disease response
‣ a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
⁃ b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes
• Hormone-sensitive prostate cancer
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)
• Willingness to fill out quality of life and psychosocial forms
• Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)