Trials / Recruiting
RecruitingNCT06392295
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- University of Miami · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-07-03
- Primary completion
- 2027-08-01
- Completion
- 2029-08-01
- First posted
- 2024-04-30
- Last updated
- 2025-06-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06392295. Inclusion in this directory is not an endorsement.