Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histopatologicznie rak prostaty
- •Widoczna w badaniu PSMA-PET mała zmiana (poniżej 1 cm) w węźle chłonnym w miednicy
- •Brak wcześniejszego leczenia raka
- •Wiek co najmniej 30 lat
- •Zdolność połykania leków
- •Dobry ogólny stan zdrowia (skala ECOG ≤ 2)
- •Możliwość uczestniczenia w badaniu przez 5 lat
✗ Disqualifies
- •Przerzuty nowotworu poza węzły chłonne miednicy
- •Poważne problemy z sercem (zawał, niewydolność, niestabilna dławica w ostatnich 3 miesiącach)
- •Udar mózgu lub mini-udar w ostatnich 3 miesiącach
- •Niekontrolowana cukrzyca
- •Choroby zapalne jelit lub choroby tkanki łącznej
- •Poważne zaburzenia rytmu serca wymagające leczenia
- •Problemy z uzależnieniami (alkohol, narkotyki)
Simplified criteria — AI translation
Trial details
- Minimum age
- 30 Years
- Last updated (source)
- August 19, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
University of Nebraska Medical Center
Omaha, United States
Trial contact
Taylor Johnson, MA
IIT OFFICE
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/20/2026.
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