New vaccine combo aims to halt prostate cancer growth without surgery
NCT ID NCT07574541
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 60 times
Summary
This phase 2 trial tests a combination of a vaccine (TriAdeno) and an immune-boosting drug (N-803) in 52 men with early-stage, low- or medium-risk prostate cancer who are currently on active surveillance. The vaccine targets three proteins found in prostate cancer cells, while N-803 helps activate the immune system. The goal is to see if this treatment can increase immune cell activity inside the tumor and potentially slow or stop cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TriAdeno vaccine and N-803 (a drug that boosts the immune system)
- What this could lead to
- If it works, this could help men with early-stage prostate cancer avoid or delay more aggressive treatments like surgery or radiation.
- What could go wrong
- This is a small, early-phase trial (52 people) testing safety and immune response, not yet proven to stop cancer growth. Side effects from the vaccine and N-803 are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 and 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 109/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 m2 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 vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \[IUD\], surgical sterilization). 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. EXCLUSION CRITERIA: * Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy. * Evidence of PCa with metastatic disease. * Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines. * Prior solid organ or bone marrow transplant. * Immunodeficiency or splenectomy. * 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. * 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. * Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions. * 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. * History of herbal products that may decrease PSA levels (e.g., saw palmetto). * 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. * History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Light-Based imaging aims to spot prostate cancer left behind after surgery
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer