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NCT06392295RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
34 (estimated)
First submitted
25 Apr 2024
Start date
3 Jul 2024
Primary completion date
1 Aug 2027
Lead sponsor
University of Miami
NCT number
NCT06392295

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 34
  • From 3 Jul 2024 to the primary completion date, 1 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of prior radiation therapy outside the pelvis for prostate cancer
  • 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

Other illness

  • Patient has more than 5 sites of metastatic disease
  • Patient has history of bone and/or visceral metastasis
  • No evidence of disease in the para-aortic or pelvic lymph nodes
  • Bulky nodal disease \>5 cm in tumor size
  • Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
  • History of inflammatory bowel disease
  • History of malignancy other than prostate cancer except for non-melanoma skin cancer

Lab values

  • Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \<50 ng/dL)

Other

  • No pathological diagnosis of prostate adenocarcinoma
  • No staging with PSMA PET/CT scan
  • Implanted hardware which limits treatment planning or delivery (determined by treating physician)
  • Patients with ECOG performance status \> 2
  • Patients unable to consent or are prisoners
  • Unwilling to fill out quality of life and psychosocial forms
  • Participants with impaired decision-making capacity

Who the study is looking for

  • Histologically proven prostate adenocarcinoma
  • Male, ≥ 18 years old
  • 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)
  • 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
  • Hormone-sensitive prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • 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)
  • Willingness to fill out quality of life and psychosocial forms
  • Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.