Actively Recruiting
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
Led by University of Nebraska · Updated on 2026-04-15
140
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \<1 cm in smallest diameter). This study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy. A total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes. The primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival. Exploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.
CONDITIONS
Official Title
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically proven diagnosis of local prostate cancer confirmed by pathology review if biopsy done outside the institution
- Presence of PSMA-avid pelvic lymph node measuring less than 1 cm in short axis diameter
- No prior definitive treatment or intervention for prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less within 14 days before registration
- Age 30 years or older
- Ability to provide informed consent specific to this study
- Ability to swallow medications
You will not qualify if you...
- Evidence of distant metastatic disease beyond pelvic lymph nodes, including bone disease in the pelvis
- Any psychological, family, social, or geographic condition that may interfere with study compliance or follow-up, including alcohol dependence or drug abuse
- Contraindications to radiation therapy such as inflammatory bowel disease, connective tissue disorders, or genetic conditions increasing radiation sensitivity
- Severe active co-morbidities including unstable angina or heart failure requiring hospitalization within 3 months prior, NYHA class II or greater heart failure, recent myocardial infarction or stroke within 3 months, uncontrolled diabetes, arrhythmias above Grade 2 (stable atrial fibrillation allowed), recent thromboembolic events, significant vascular diseases, infections requiring intravenous antibiotics, respiratory illness needing hospitalization, hepatic insufficiency causing jaundice or coagulation problems, AIDS treated with contraindicated medications, uncontrolled or recent seizures, recent severe bleeding events, recent non-healing wounds or fractures, or elevated liver function tests beyond specified limits.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
T
Taylor Johnson, MA
CONTACT
I
IIT OFFICE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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