PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
About This Trial
- This study is testing whether using targeted radiation therapy alongside hormone therapy can help control cancer that has returned, while also protecting your quality of life.
- Doctors will use specialized imaging scans to precisely find and deliver radiation to lymph nodes in the lower belly and pelvis.
- The trial is for men whose prostate cancer has come back in only a few lymph nodes (up to five spots) after prior radiation, with no spread to the bones or other organs.
- Before considering this study, you should know that you cannot have received recent chemotherapy or hormone therapy, and you will be asked to complete regular questionnaires about your daily well-being.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether using targeted radiation therapy alongside hormone therapy can help control cancer that has returned, while also protecting your quality of life.
Study Details
- Start Date: July 3, 2024
- Lead Sponsor: University of Miami
Full Eligibility Criteria
Inclusion Criteria
- 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 pelvic or para-aortic lymph nodes
- d. Non-bulky nodal disease (ie, tumor 5 cm in tumor size
- Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
- Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
- Implanted hardware which limits treatment planning or delivery (determined by treating physician)
- Castration-resistant prostate cancer (history of rising PSA with serum testosterone level 2
- History of inflammatory bowel disease
- History of malignancy other than prostate cancer except for non-melanoma skin cancer
- Patients unable to consent or are prisoners
- Unwilling to fill out quality of life and psychosocial forms
- Participants with impaired decision-making capacity
Treatments
- Radiation: Para Aortic Radiation Therapy: Photon Therapy
- Radiation: Para Aortic Radiation Therapy: Proton Therapy
- Drug: Androgen Deprivation Therapy
- Drug: Androgen Receptor Signaling Inhibitor

