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New vaccine combo aims to halt prostate cancer growth without surgery

NCT ID NCT07574541

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 120 years

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.