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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be followed for 5 years after completion of ADT to assess outcomes."
- "Patients will be followed for 5 years after completion of ADT to evaluate outcomes."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding abiraterone and prednisone to hormone treatment helps keep prostate cancer from getting worse. Both groups also get radiation treatment. It is for people with prostate cancer and small lymph nodes in the pelvis that show cancer on a PSMA-PET scan but not on standard scans.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 30 or older.
- Prostate cancer confirmed by a biopsy (a tissue sample). Samples taken outside UNMC must be checked by its lab.
- A lymph node in the pelvis that shows cancer on a PSMA-PET scan, can be targeted for treatment, and measures less than 1 cm across its shorter side.
- No prior treatment or procedure meant to treat the cancer fully.
- Able to care for yourself and be out of bed or a chair for more than half the day, checked within 14 days before signing up.
- Able to understand and sign the study consent form before joining.
- Able to swallow medicines.
Who can't join
- Cancer has spread beyond the pelvic lymph nodes, including to bones in the pelvis.
- Personal, family, mental health, travel, alcohol, or drug problems that could prevent following study rules or attending visits.
- A condition that makes radiation unsafe, as judged by your doctor. Examples include inflammatory bowel disease and some connective tissue or genetic disorders.
- Certain serious heart or blood vessel problems; a heart attack, stroke, or mini-stroke within 3 months; or a blood clot within 1 month. Some stable irregular heartbeats are allowed.
- Uncontrolled diabetes; a bacterial or fungal infection needing antibiotics through a vein; or a lung illness that requires a hospital stay or prevents study treatment.
- Liver failure causing yellow skin or eyes or blood-clotting problems, or liver blood tests above the study limits. A different bilirubin limit applies to people with Gilbert’s disease.
- AIDS treated with medicines that cannot be taken with the study drugs. HIV testing is not required.
- Uncontrolled seizures or seizures within 3 months; severe bleeding within 30 days; or a wound, sore, or broken bone that has not healed within 90 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
NE
- University of Nebraska Medical Center · Omaha, NE 68198Heather Mittelstedt, RN · Study contact · 402-559-8287 · hmittelstedt@unmc.eduMichael Baine, MD/PhD · Principal investigatorMore trials in Omaha