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.

Eligibility

Age range

30+ years

Sex

Male

Healthy volunteers

No

Interventions

• 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

Location