Abiraterone and prednisone plus ADT versus ADT for PSMA-positive, conventionally node-negative prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial will enroll 140 men with biopsy-proven prostate cancer who have PSMA-PET–positive pelvic lymph nodes smaller than 1 cm on conventional imaging. Participants are randomized to receive either standard ADT with concurrent radiation or enhanced ADT consisting of ADT plus abiraterone and prednisone with concurrent radiation. The primary outcome is 5-year failure-free survival, with participants followed for five years after completing ADT to capture recurrence and longer-term outcomes. The trial aims to clarify whether intensified systemic therapy improves outcomes for patients who are conventionally node-negative but PSMA-avid on advanced imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.
2. Targetable PSMA-avid pelvic lymph node measuring \<1cm in short axis diameter.
3. No prior definitive treatment or intervention received.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration.
5. Age ≥ 30 years.
6. Patient must be able to provide study-specific informed consent prior to study entry.
7. Patient must be able to swallow medications.

Exclusion Criteria:

1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).
2. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
3. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but are not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.
4. Severe, active co-morbidity, defined as follows:

   1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months prior to registration.
   2. Congestive heart failure (NYHA functional capacity class II or greater).
   3. Transmural myocardial infarction within the last 3 months prior to registration.
   4. History of stroke or transient ischemic attack within 3 months prior to registration.
   5. Currently uncontrolled diabetes mellitus.
   6. Ongoing arrhythmias of Grade \>2 \[National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE), version 5.03\]; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
   7. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month.
   8. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
   9. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
   10. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
   11. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
   12. Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention definition that is being treated with contraindicated medications, including but not limited to Atazanavir, Saquinavir, Ritonavir, Indinavir, or Nelfinavir. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
   13. Uncontrolled seizures or seizures in the past 3 months. Patients can enroll if their seizures have been well-controlled for \>3 months on antiseizure medications.
   14. Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration.
   15. History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration.
   16. Total bilirubin ≥1.5X upper limit of normal (ULN) \[except for subjects with Gilbert's disease, in which case total bilirubin not to exceed 10X ULN\], alanine (ALT) and aspartate (AST) aminotransferase \>= 2.5X ULN.

Where it's running

• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Michael Baine, MD, PhD — Fred & Pamela Buffett Cancer Center, University of Nebraska, 987521 Nebraska Medical Center
• Study coordinator: Taylor Johnson, MA
• Email: taylora.johnson@unmc.edu
• Phone: 402-559-4596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.