Study on Atezolizumab-Based Combination Therapy Before Surgery for Men with Localized Prostate Cancer

Sponsor: David Oh

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03821246

Provider View

This clinical trial is exploring how well the drug atezolizumab, alone or combined with other medications, works in treating men with localized prostate cancer before they undergo surgery to remove the prostate. The study aims to see if these treatments can help the immune system fight cancer more effectively.

Patient Parameters

Program Overview

This study is testing the effectiveness of atezolizumab, an immunotherapy drug, either alone or combined with etrumadenant or tocilizumab, in treating men with localized prostate cancer before surgery. Atezolizumab may help the immune system attack cancer cells, while etrumadenant and tocilizumab may further enhance this effect. The goal is to see if these combinations can better control prostate cancer before surgery.

Description

The main goal of this study is to see how atezolizumab-based combination therapy affects immune cells within prostate tumors. Researchers also want to determine how safe and effective these treatments are for men with localized prostate cancer.

Participants will be divided into groups to receive different treatments:

  • Cohort A: Patients receive one cycle of atezolizumab through an IV before surgery.
  • Cohort B: Patients receive one cycle of atezolizumab and etrumadenant before surgery.
  • Cohort C: Patients receive one cycle of atezolizumab and tocilizumab before surgery.

The surgery to remove the prostate will take place about 21 days after the first treatment. After surgery, participants will have follow-up visits at 6 weeks, 3 months, 6 months, and 12 months, or until the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by lab tests.
  • Eligible for surgery to remove the prostate, as determined by a specialist.
  • Only patients with high-risk prostate cancer are eligible initially; those with intermediate-risk may join later.
  • Must provide a tumor sample for study analysis.
  • No previous treatments for prostate cancer.
  • Aged 18 years or older.
  • In good general health, with specific blood and organ function levels.
  • Must agree to use contraception during the study and for 4 months after treatment.
  • Able to understand and sign a consent form and follow study procedures.

Exclusion Criteria

  • Evidence of cancer spread beyond the prostate.
  • Not eligible for prostate surgery.
  • Previous treatments for prostate cancer, including hormone therapy or chemotherapy.
  • History of other cancers, except for certain treated skin or early-stage cancers.
  • Autoimmune diseases or immune deficiencies, with some exceptions.
  • Lung diseases requiring high-dose steroids.
  • Significant heart disease or recent heart attack.
  • Active infections like hepatitis or HIV.
  • Recent major surgery or severe infections.
  • Pregnant or breastfeeding women.
  • Previous treatments with certain immune therapies or investigational drugs.
  • Allergies to study drugs or their components.
  • Other serious medical conditions that could interfere with the study.

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