A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
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
Study locations (1)
University of Miami
Miami, Florida, 33136