Study on Cabozantinib and Atezolizumab for Treating Metastatic Castration-Resistant Prostate Cancer (The AtezoCab Trial)

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05168618

Provider View

This clinical trial is exploring whether a combination of cabozantinib and atezolizumab can help shrink tumors in men with prostate cancer that has spread and is resistant to hormone therapy. The study aims to see if these drugs can work together to stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing a combination of two drugs, cabozantinib and atezolizumab, to see if they can effectively reduce tumors in men with prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. Cabozantinib may help by blocking certain enzymes that cancer cells need to grow, while atezolizumab, an immunotherapy drug, may help the immune system attack cancer cells. The goal is to see if using these drugs together can kill more cancer cells in patients with this type of prostate cancer.

Description

The main goal of this study is to see how well the combination of cabozantinib and atezolizumab controls the disease in patients with metastatic castration-resistant prostate cancer (mCRPC) who have non-measurable disease. Researchers will also look at how long patients live without the cancer getting worse, how many patients have a significant drop in prostate-specific antigen (PSA) levels, and overall survival rates. The safety of the drug combination will also be evaluated.

Patients in the study will take cabozantinib by mouth once a day and receive atezolizumab through an IV on the first day of each 21-day cycle. This treatment will continue as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits to monitor their health and any changes in their cancer.

The study will also explore how the treatment affects cancer cells and why some patients may not respond to the therapy.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
  • Cancer must have progressed after previous hormone treatments.
  • Must have non-measurable disease outside the pelvis, such as bone lesions.
  • Must have tried at least one other hormone therapy before.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Low testosterone levels due to previous treatments.
  • Available tumor tissue sample for analysis.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Agree to use effective contraception during the study and for 5 months after the last treatment.
  • Able to understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Previous chemotherapy for metastatic castration-resistant prostate cancer.
  • Previous treatment with cabozantinib or certain immune therapies.
  • Recent use of other cancer treatments or investigational drugs.
  • Active or untreated brain metastases.
  • Uncontrolled pain or other serious medical conditions.
  • Recent major surgery or radiation therapy.
  • Other active cancers requiring treatment.
  • Significant heart, liver, or kidney problems.
  • Active infections or immune system disorders.
  • History of severe allergic reactions to study drugs.
  • Use of certain blood thinners or recent live vaccines.
  • Any condition that would make participation unsafe or affect study results.

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