IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy
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
Background: Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation. Objective: To test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past. Eligibility: People aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT). Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors. N-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh. Participants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071. The drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles. Participants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated. Follow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej.
- •Rak prostaty, który powrócił po wcześniejszym leczeniu (radioterapii celowanej).
- •Potwierdzenie raka prostaty przez lekarzy.
- •Poziom PSA we krwi wskazujący na nawrót choroby.
- •Pełne wyzdrowienie z poprzednich terapii.
- •Prawidłowe wyniki badań wątroby i nerek.
- •Ogólny stan zdrowia pozwalający na udział w badaniu (skala ECOG 0-1).
✗ Disqualifies
- •Inne aktywne choroby nowotworowe w ciągu ostatnich 3 lat (z wyjątkiem raka skóry i niektórych nowotworów pęcherza).
- •Kobiety w ciąży lub karmiące piersią.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 120 Years
- Last updated (source)
- October 6, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Amy R Hankin, P.A.-C
Melissa L Abel, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/26/2026.
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