Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy
Summary
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.
Arms & interventions
- DrugAndrogen Deprivation Therapy (ADT)
Standard hormone therapy used for prostate cancer treatment
- DrugAbiraterone
Abiraterone administered as part of enhanced androgen deprivation therapy
- DrugPrednisone
Prednisone administered in combination with abiraterone
- RadiationRadiation Therapy
Radiation therapy administered per protocol to the prostate and/or pelvic lymph nodes
Outcome measures
Primary
5-year failure-free survival rate
Determine the impact of enhanced ADT with abiraterone/prednisone versus standard ADT on the 5-year failure-free survival of patients with PSMA-positive conventionally negative pelvic lymphadenopathy (i.e. \<1cm in smallest diameter).
Time frame: From randomization up to 5 years
Secondary
Toxicity in both arms from 3 months to 2 years post-ADT.
Time frame: From 3 months to 2 years post-ADT
Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (IPSS)
Time frame: From 3 months to 2 Years post-ADT
Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (FACT-P)
Time frame: From 3 months to 2 Years post-ADT
Evaluate local progression-free survival (i.e., failure-free survival excluding biochemical failure).
Time frame: From randomization up to 5 years
Evaluate locoregional progression-free survival (i.e., failure-free survival excluding biochemical failure).
Time frame: From randomization up to 5 years
Evaluate 5-year overall survival
Time frame: From randomization up to 5 years
Evaluate 5-year cancer-specific survival
Time frame: From randomization up to 5 years
Evaluate 5-year metastasis-free survival.
Time frame: From randomization up to 5 years
Eligibility criteria
Study locations (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198