Study on TriAdeno Vaccine and N-803 for Early-Stage Prostate Cancer in Active Surveillance

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07574541

Provider View

This clinical trial is testing a new vaccine, TriAdeno, combined with the drug N-803, to see if it can help stop the growth of early-stage prostate cancer in men who are being actively monitored instead of receiving immediate treatment.

Patient Parameters

Program Overview

Prostate cancer is a common cancer in men and a leading cause of cancer-related deaths. Many men with early-stage prostate cancer are monitored closely without immediate treatment, but about 35% will need treatment within 5 years due to tumor growth. This study is exploring whether a new vaccine, TriAdeno, combined with the drug N-803, can help prevent tumor growth in these patients.

Description

This study involves a new vaccine called TriAdeno, which targets three proteins associated with cancer, and a drug called N-803, which is already used for bladder cancer. The goal is to see if this combination can help stop the growth of early-stage prostate cancer in men who are being actively monitored.

Participants will receive injections of TriAdeno under the skin of the upper thigh and N-803 under the skin of the abdomen. These treatments will be given in up to four cycles, each lasting 21 days. Participants will receive both injections on the first day of each cycle.

Participants may choose to keep a diary of their symptoms for a week after each injection and complete a questionnaire about their prostate symptoms. Blood tests, imaging scans, and other tests will be repeated during the study.

A biopsy of the tumor will be taken during or after the second cycle, and another biopsy may be taken about a year later. Participants will have follow-up phone calls for five years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older with early-stage, low- or medium-risk prostate cancer confirmed by biopsy.
  • Must be on active surveillance, meaning they are being closely monitored instead of receiving immediate treatment.
  • Must have a PSA level below 20 ng/mL (or below 10 ng/mL if taking certain medications).
  • Must be in good overall health with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must agree to use effective contraception during the study and for one month after the last treatment.
  • Must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

  • Previous treatment for prostate cancer, such as surgery, radiation, or hormone therapy.
  • Evidence of prostate cancer that has spread beyond the prostate.
  • Previous treatment with similar vaccines or therapies.
  • History of organ or bone marrow transplant.
  • Immunodeficiency or removal of the spleen.
  • Active infections, including HIV, hepatitis B, or hepatitis C.
  • History of autoimmune diseases, except for well-controlled thyroid disease, type I diabetes, or vitiligo.
  • History of heart disease or recent heart problems.
  • Skin disorders that would interfere with injections or assessments.
  • Another cancer within the past three years, except for certain skin or bladder cancers.
  • Recent use of herbal products that affect PSA levels.
  • Recent surgery or participation in another clinical trial.
  • Allergic reactions to similar drugs.
  • Other uncontrolled illnesses that would affect participation.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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