Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
United States52 participantsStarted 2026-07-01
Plain-language summary
Background:
Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.
Objective:
To test TriAdeno and N-803 in people with early-stage prostate cancer.
Eligibility:
People aged 18 years and older with early-stage low- or medium-risk prostate cancer.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.
TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.
Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.
Blood tests, imaging scans, and other tests will be repeated during the study.
A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.
Participants will have follow-up phone calls for 5 years....
Who can participate
Age range
18 Years – 120 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-Calculated Creatinine clearance \>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of an adenovirus-based vaccine called TriAdeno and an immune-boosting agent called N-803 — since it's a Phase 2 trial, what do we know so far about the safety profile of these two treatments together, and what side effects should I realistically expect?
2The main thing this trial is measuring is whether the vaccine changes the immune environment inside the prostate tumor itself — what does that mean for me practically, and would I need additional biopsies or procedures beyond what my active surveillance already involves?
3Since this trial is not yet recruiting, how far out do you think it might actually open, and should I continue on my current active surveillance plan in the meantime rather than waiting to see if I'm eligible?
4Given that my cancer is being managed with active surveillance, is there any concern that participating in an immunotherapy trial like this could affect the standard monitoring milestones we use to decide if treatment becomes necessary down the road?
5Are there standard treatment options or other clinical trials already enrolling that we should compare this one against, especially given that this trial hasn't started yet and my situation may not wait indefinitely?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment
Timeframe: Baseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year