Actively Recruiting
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Led by University of Miami · Updated on 2025-06-15
34
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven prostate adenocarcinoma
- Male, 18 years old
- Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
- No more than 5 lesions on PSMA PET/CT scan
- No disease outside pelvic and sub-diaphragmatic para-aortic lymph nodes
- At least one lesion in the sub-diaphragmatic para-aortic lymph nodes
- Non-bulky nodal disease (tumor <5 cm)
- Prior pelvic radiation with disease response
- Hormone-sensitive prostate cancer
- ECOG Performance Status of 0-2
- Ability to understand and consent to the study
- Willingness to complete quality of life and psychosocial forms
- Willing to participate in the institution's Prostate Cancer Database Protocol
You will not qualify if you...
- No pathological diagnosis of prostate adenocarcinoma
- More than 5 metastatic disease sites
- History of bone and/or visceral metastasis
- No evidence of disease in para-aortic lymph nodes
- No staging with PSMA PET/CT scan
- Prior radiation therapy outside the pelvis for prostate cancer
- Bulky nodal disease (>5 cm tumor size)
- Androgen deprivation therapy or chemotherapy within 3 months before PSMA PET/CT staging or at enrollment
- Suspicious prostate disease on PSMA PET/CT without negative biopsy confirmation
- Implanted hardware limiting treatment planning or delivery
- Castration-resistant prostate cancer
- ECOG performance status greater than 2
- History of inflammatory bowel disease
- History of malignancy other than prostate cancer except non-melanoma skin cancer
- Unable to consent or prisoner status
- Unwilling to complete quality of life and psychosocial forms
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
B
Benjamin J Rich, MD
CONTACT
A
Alan Dal Pra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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