A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
University of Miami
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically proven prostate adenocarcinoma 2. Male, ≥ 18 years old 3. 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) 4. Prior pelvic ra…
Interventions
- RadiationPara Aortic Radiation Therapy: Photon Therapy
Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV).
- RadiationPara Aortic Radiation Therapy: Proton Therapy
Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn).
- DrugAndrogen Deprivation Therapy
Androgen deprivation therapy will be administered as per standard of care.
- DrugAndrogen Receptor Signaling Inhibitor
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.
Location
- University of MiamiMiami, Florida