NCT07237269

Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer

Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Androgen Deprivation Therapy (ADT)	Standard hormone therapy used for prostate cancer treatment
DRUG	Abiraterone	Abiraterone administered as part of enhanced androgen deprivation therapy
DRUG	Prednisone	Prednisone administered in combination with abiraterone
RADIATION	Radiation Therapy	Radiation therapy administered per protocol to the prostate and/or pelvic lymph nodes

Timeline

• Start date: 2026-04-03
• Primary completion: 2033-04-03
• Completion: 2033-04-03
• First posted: 2025-11-19
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study