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Recruiting
NCT06392295
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Conditions: Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 34
Sponsor: University of Miami
Location: University of Miami Miami Florida
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT06392295). StuddyBuddy aggregates publicly available trial information.
