PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
No pathological diagnosis of prostate adenocarcinoma
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
Trial design
Treatments tested in this trial
- Para Aortic Radiation Therapy: Photon Therapy
- Para Aortic Radiation Therapy: Proton Therapy
- Androgen Deprivation Therapy
- Androgen Receptor Signaling Inhibitor
Treatment groups
34 Participants
are divided into 1 treatment groupLocations
1University of Miami33136, MiamiFlorida, United States
Sponsors and collaborators
University of Miami
Lead sponsor
Source ClinicalTrials.gov