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Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy
Sponsor: University of Nebraska
Summary
The advent of PSMA-PET has allowed greater sensitivity and specificity when staging prostate cancers, particularly intermediate and high-risk prostate cancers. This has created a gap in knowledge regarding the treatment of patients who have PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e. \<1cm in smallest diameter). The purpose of this study is to compare outcomes of enhanced ADT with abiraterone and prednisone and standard ADT, both alongside radiation therapy, in prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We hypothesize that enhanced ADT with abiraterone and prednisone is superior to standard ADT for the treatment of prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We further hypothesize that standard ADT will be associated with a lower rate of adverse events. 140 eligible patients will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Patients will be followed for 5 years after completion of ADT to evaluate outcomes. The primary objective will be to determine if enhanced ADT has superior 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of chronic toxicities, quality of life impact, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival. Additionally, the study will have two exploratory objectives involving assessment of tumor growth rate and regression rate using PSA values and determine the correlation of treatment efficacy and toxicity with blood-based Heme oxygenase 1 (HO-1) concentration. If enhanced ADT is not superior to standard ADT for prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy, this would suggest that treatment with standard ADT may be adequate and thus be a strong impetus for larger multi-institutional clinical trials to investigate this notion.
Key Details
Gender
MALE
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-02-01
Completion Date
2033-02-01
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Hormone therapy
Abiraterone/Prednisone + Standard Hormone Therapy (ADT) = Enhanced Hormone Therapy; Standard Hormone Therapy (ADT) alone = SOC
Locations (1)
University of Nebraska Medical Center
Omaha, Nebraska, United States