RecruitingPhase 2interventionalRules rewrite

Phase 2: testing TriAdeno vaccine for Adenocarcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07574541 · National Cancer Institute (NCI) · enrollment listed as 52

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TriAdeno vaccine, or N-803. The registry lists allocation as na. Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States.

They plan to enroll about 52 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: TriAdeno vaccine, N-803

Primary outcome (registry wording): To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment

Who it is for (from inclusion criteria)

Ages 18 Years to 120 Years
Men only
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)
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

Who the registry excludes

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

Public study contact (from the registry)

Genevieve C Fromm

(240) 858-3663

genevieve.fromm@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07574541 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07574541?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07574541?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary