Clinical trial · Interventional
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
NCT06392295CI-TRIAL-00114978OCEANrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Sensitive Prostate Cancer | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy | Drug | — | UNRESOLVED |
| Androgen Receptor Signaling Inhibitor | Drug | — | UNRESOLVED |
| Para Aortic Radiation Therapy: Photon Therapy | Radiation | — | UNRESOLVED |
| Para Aortic Radiation Therapy: Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA-Guided PA-RT Group
- description
- Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy. Total participation duration is up to five years.
- interventionNames
- Radiation: Para Aortic Radiation Therapy: Photon Therapy
- Radiation: Para Aortic Radiation Therapy: Proton Therapy
- Drug: Androgen Deprivation Therapy
- Drug: Androgen Receptor Signaling Inhibitor
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.