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RECRUITING
NCT06392295
PHASE2

PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer

Sponsor: University of Miami

View on ClinicalTrials.gov

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

RADIATION

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).

RADIATION

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).

DRUG

Androgen Deprivation Therapy

Androgen deprivation therapy will be administered as per standard of care.

DRUG

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