Study Comparing Abiraterone/Prednisone with Standard Hormone Therapy for Prostate Cancer Patients with PSMA-Positive but Conventional Imaging Negative Pelvic Lymph Nodes

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07237269

Provider View

This clinical trial is exploring whether adding the drugs abiraterone and prednisone to standard hormone therapy, along with radiation, is more effective than standard hormone therapy alone for prostate cancer patients with specific PSMA-positive lymph nodes that don't show up on regular scans.

Patient Parameters

Program Overview

This study aims to find out if a combination of abiraterone and prednisone with standard hormone therapy and radiation is better at treating prostate cancer in patients with PSMA-positive lymph nodes that are not visible on conventional imaging. The study will compare this enhanced treatment to standard hormone therapy with radiation. Researchers believe the enhanced treatment might improve survival without cancer returning over five years. They will also look at side effects, quality of life, and other survival measures. If the enhanced treatment is not better, it could mean standard therapy is sufficient, prompting further research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with local prostate cancer confirmed by lab tests.
  • Have PSMA-positive pelvic lymph nodes less than 1 cm in size.
  • Have not received any prior definitive treatment for prostate cancer.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Be 30 years or older.
  • Be able to understand and sign a consent form.
  • Be able to swallow pills.

Exclusion Criteria

  • Cancer has spread beyond pelvic lymph nodes.
  • Conditions that might prevent following the study plan, like severe psychological or social issues, or substance abuse.
  • Cannot safely receive radiation therapy due to certain medical conditions like inflammatory bowel disease or connective tissue disorders.
  • Severe health issues such as recent heart problems, uncontrolled diabetes, or recent blood clots.
  • Active infections needing IV antibiotics.
  • Severe lung disease or liver problems.
  • AIDS with certain medications that conflict with the study.
  • Uncontrolled seizures or recent severe bleeding.
  • Recent non-healing wounds or fractures.
  • Abnormal liver function tests unless due to Gilbert's disease.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.