Study on Androgen Deprivation with or without pTVG-AR Vaccine and T-Cell Checkpoint Blockade for High-Risk Prostate Cancer

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04989946

Provider View

This clinical trial is exploring a new treatment approach for patients with newly diagnosed high-risk prostate cancer. It involves using a DNA vaccine, with or without additional immune system therapies, alongside standard hormone therapy before surgery.

Patient Parameters

Program Overview

The study aims to test a new treatment method for patients with high-risk prostate cancer who are scheduled for surgery. It involves using a DNA vaccine that targets the androgen receptor (AR), either alone or combined with drugs that help the immune system fight cancer. The goal is to see if this approach can increase the number of cancer-fighting T-cells in the prostate and improve treatment outcomes. Patients will be part of the study for up to 15 months.

Description

This study is testing a new treatment for high-risk prostate cancer that combines hormone therapy with a DNA vaccine targeting the androgen receptor (AR). The vaccine may be used alone or with drugs that help the immune system, like nivolumab, to boost the body's ability to fight cancer. The study will have different groups to test these combinations.

Participants will receive hormone therapy with degarelix for 8 weeks before surgery. Some will also get the DNA vaccine, and others will receive the vaccine with additional immune-boosting drugs. The study will look at how well these treatments work together to increase cancer-fighting T-cells in the prostate.

The main goals are to see if the treatment is safe and if it can reduce cancer in the prostate before surgery. Researchers will also check if the treatment helps keep PSA levels low for a year after surgery and if it reduces the amount of cancer left after treatment.

The study will also explore how the treatment affects the immune system and if it leads to changes detectable by special imaging tests. If the results are promising, the study may expand to include more patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the prostate.
  • Eligible for prostate surgery as part of standard care.
  • Considered high-risk for cancer recurrence based on specific medical criteria.
  • Life expectancy of at least 12 months.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood, kidney, and liver function based on recent tests.
  • No history of certain infections like HIV or active hepatitis.
  • Willing to provide tissue samples and undergo blood draws for research.
  • Agree to use barrier contraception during treatment if sexually active.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have a type of prostate cancer other than adenocarcinoma.
  • Have received prior treatment for prostate cancer, including hormone therapy or radiation.
  • Currently taking other investigational drugs or cancer treatments not part of the study.
  • Taking certain medications that affect hormones or the immune system.
  • Have had major surgery recently or have active heart disease.
  • Have psychological or social issues that could affect participation.
  • Have other active cancers, except for certain skin cancers or bladder cancer that have been treated.
  • Have a history of severe autoimmune disease or lung inflammation.
  • Have had a live vaccine recently or have allergies to the tetanus vaccine.

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