RecruitingPhase 2NCT03821246

Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy

An Open-Label Multi-Center Phase II Study of Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy


Sponsor

David Oh

Enrollment

68 participants

Start Date

Oct 30, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving an immunotherapy drug called atezolizumab (which helps the immune system attack cancer) in combination with other medications before surgical removal of the prostate can shrink or eliminate high-risk localized prostate cancer. **You may be eligible if...** - You have been diagnosed with prostate cancer confirmed by biopsy (adenocarcinoma) - You are eligible for and have agreed to a radical prostatectomy (complete surgical removal of the prostate) - You have high-risk prostate cancer (intermediate-risk patients may be included later after safety checks) - Tissue from your tumor is available for research analysis **You may NOT be eligible if...** - You have a rare subtype of prostate cancer (small cell or neuroendocrine) - Your surgeon has not confirmed you are eligible for surgery - Tumor tissue is not available for analysis - Your overall health is too poor to undergo surgery or the study treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Given IV

DRUGTocilizumab

Given IV

DRUGEtrumadenant

Given Orally


Locations(2)

University of California, San Francisco

San Francisco, California, United States

Alvin J. Siteman Cancer Center at Washington University

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT03821246


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