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RecruitingInterventionalPhase 2

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial

NCT ID: NCT06392295Sponsor: University of MiamiLast updated: 2026-06-16

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.

Arms & 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.

Outcome measures

Primary

  • Progression-free Survival (PFS)

    Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.

    Time frame: Up to 2 years

Secondary

  • Biochemical Failure-Free Survival (FFS)

    Time frame: Up to 2 years

  • Metastasis-Free Survival

    Time frame: Up to 2 years

  • Overall Survival (OS)

    Time frame: Up to 2 years

  • Median Cause Specific Survival

    Time frame: Up to 2 years

  • Proportion of Participants Undergoing Escalation of Therapy

    Time frame: Up to 2 years

  • Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity

    Time frame: Up to 2 years

  • Change in Quality of Life Scores: EPIC 26 Short Form

    Time frame: Up to 2 years

  • Change in Quality of Life Scores: HADS

    Time frame: Up to 2 years

  • Change in Quality of Life Scores: IPSS

    Time frame: Up to 2 years

  • Complete Early Response Rate

    Time frame: Up to 2 years

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 pelvic or 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. Hormone-sensitive prostate cancer 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s) 8. Willingness to fill out quality of life and psychosocial forms 9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767) 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 or pelvic 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) 11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \<50 ng/dL) 12. Patients with ECOG performance status \> 2 13. History of inflammatory bowel disease 14. History of malignancy other than prostate cancer except for non-melanoma skin cancer 15. Patients unable to consent or are prisoners 16. Unwilling to fill out quality of life and psychosocial forms 17. Participants with impaired decision-making capacity

Study locations (1)

University of Miami

Miami, Florida, 33136

Recruiting
Benjamin J Rich, MD · Contact
Benjamin J Rich, MD · Principal Investigator
Alan Dal Pra, MD · Principal Investigator
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer | Cancerify