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NCT07574541RecruitingPhase 2

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

Phase II Trial of a 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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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....

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
52 (estimated)
First submitted
7 May 2026
Start date
8 Nov 2026
Primary completion date
15 Jun 2028
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT07574541

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 52
  • From 8 Nov 2026 to the primary completion date, 15 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.
  • Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.
  • Prior solid organ or bone marrow transplant.
  • History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly
    • controlled angina, or history (\<1 year prior to initiation of study therapy) of ventricular arrhythmia.
  • Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.
  • Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.
  • Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.

Other illness

  • Evidence of PCa with metastatic disease.
  • Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.
  • History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.
  • Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.
  • History of herbal products that may decrease PSA levels (e.g., saw palmetto).
  • History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.

Lab values

  • Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.

Other

  • Immunodeficiency or splenectomy.

Criteria the registry did not label

  • INCLUSION CRITERIA:
  • Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.
  • Participants must be on active surveillance.
  • Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \[FFPE\] biopsy core or one H\&E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.
  • Serum PSA level of \<20 ng/mL (or \<10ng/mL for participants being treated with 5- alpha-reductase inhibitors)
  • Clinical stage \<=T2a by digital rectal exam (DRE)
  • Age \>=18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status \<=1.
  • Adequate organ and marrow function as defined below:
    • Absolute neutrophil count (ANC) \>=1.0 x 10\^9/L
    • Hemoglobin (Hgb) \>=9 g/dL
    • Platelets \>=75,000/mcL
    • Prothrombin International Normalized Ratio (INR) \<1.5 x upper limit of normal (ULN)
    • Partial thromboplastin time (PTT) \<1.5 x ULN
    • Total bilirubin \<1.5 x ULN
    • Aspartate aminotransferase (AST) \<=2.5 x ULN
    • Alanine aminotransferase (ALT) \<=2.5 x ULN
    • Creatinine \<=1.5 x ULN
    • OR
    • --Calculated Creatinine clearance \>=40 mL/min/1.73 m\^2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
  • Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.
  • Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.
  • Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last study drug injection. Participants must not freeze or donate sperm within the same period.
  • Participants must be able to understand and willing to sign a written informed consent document.

Age in the registry: 18 years to 120 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status		BethesdaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.