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PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06392295•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

18 - No limit years

Sex

MALE

Healthy Volunteers

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 radiation with disease response
•* a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
•* b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes
+5 more criteria

Exclusion Criteria

•1. No pathological diagnosis of prostate adenocarcinoma
•2. Patient has more than 5 sites of metastatic disease
•3. Patient has history of bone and/or visceral metastasis
•4. No evidence of disease in the para-aortic lymph nodes
•5. No staging with PSMA PET/CT scan
•6. History of prior radiation therapy outside the pelvis for prostate cancer
•7. Bulky nodal disease \>5 cm in tumor size
•8. 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
•9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
•10. Implanted hardware which limits treatment planning or delivery (determined by treating physician)
+7 more criteria

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

July 3, 2024

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2029

Last Updated

June 15, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate CancerProstate AdenocarcinomaHormone Sensitive Prostate Cancer

Interventions

Para Aortic Radiation Therapy: Photon Therapy

RADIATION

Para Aortic Radiation Therapy: Proton Therapy

RADIATION

Androgen Deprivation Therapy

DRUG

Androgen Receptor Signaling Inhibitor

DRUG

Contacts

Benjamin J Rich, MD

CONTACT

305-243-4200 brich@miami.edu

Alan Dal Pra, MD

CONTACT

305-243-4200 alan.dalpra@med.miami.edu

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC