RecruitingPhase 2NCT06392295

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


Sponsor

University of Miami

Enrollment

34 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether targeted radiation therapy to lymph nodes near the aorta (a region called the para-aortic area) can control prostate cancer that has come back in that region after prior pelvic radiation treatment. The radiation targets are identified using a PSMA PET scan — a highly sensitive imaging tool. **You may be eligible if...** - You are a man aged 18 or older - You have prostate cancer that has returned (recurred) and is limited to the lymph nodes in the pelvis and just above the pelvis (sub-diaphragmatic region) - You have 5 or fewer spots on a PSMA PET/CT scan - You previously had radiation to the prostate or prostate bed - Your cancer is still hormone-sensitive **You may NOT be eligible if...** - Your cancer has spread beyond the sub-diaphragmatic lymph nodes (e.g., to organs or bones) - You have more than 5 spots on your PSMA scan - You have a tumor larger than 5 cm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06392295


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