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PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Sponsor: 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.
Official title: A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2024-07-03
Completion Date
2029-08-01
Last Updated
2025-06-15
Healthy Volunteers
No
Interventions
Para 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).
Para 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).
Androgen Deprivation Therapy
Androgen deprivation therapy will be administered as per standard of care.
Androgen Receptor Signaling Inhibitor
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.
Locations (1)
University of Miami
Miami, Florida, United States