Actively Recruiting
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
Led by David Oh · Updated on 2025-05-15
68
Participants Needed
2
Research Sites
339 weeks
Total Duration
On this page
Sponsors
D
David Oh
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate (small cell or neuroendocrine prostate cancer patients are not eligible)
- Eligible for radical prostatectomy and consent to proceed with surgery
- High-risk disease for safety lead-in; intermediate-risk disease eligible after safety review
- Availability of suitable tumor specimen for study analyses
- No prior systemic or local therapy for prostate cancer
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function as specified in criteria
- Testosterone level above 150 ng/dL
- Agreement to use contraception or abstain from sperm donation during treatment and for 4 months after last dose
- Stable anticoagulation regimen if applicable
- Ability to understand and sign informed consent
- Ability to comply with study protocol as judged by investigator
You will not qualify if you...
- Evidence of metastatic disease
- Not a candidate for radical prostatectomy
- Prior systemic therapy for prostate cancer including antiandrogens, androgen deprivation therapy, chemotherapy, targeted therapy, immunotherapy, or radiopharmaceuticals
- Prior radiotherapy for prostate cancer
- History of prior malignancy except certain treated cancers without recurrence
- Active or history of autoimmune disease or immune deficiency with specified exceptions
- History of certain lung diseases or active pneumonitis requiring corticosteroids
- Positive HIV test
- Active hepatitis B or C infection
- Significant cardiovascular disease or recent events
- Active COPD requiring home oxygen or high-dose steroids
- Asthma requiring systemic corticosteroids over 10 mg prednisone daily
- Recent major surgery or severe infection
- Any condition contraindicating investigational drug use or increasing risk
- Prior allogeneic stem cell or solid organ transplant
- Recent live attenuated vaccine use
- Recent investigational therapy use
- Prior immune checkpoint or related therapies
- Recent use of systemic immunostimulatory or immunosuppressive medications except specified exceptions
- History of severe allergic reactions to antibodies
- Known hypersensitivity to study drugs or components
- Previous cell-depleting therapy within 5 years
- Recent intravenous gamma globulin or plasmapheresis
- Prior tocilizumab treatment except single dose case-by-case
- Prior alkylating agent or total lymphoid irradiation within 5 years
- Severe allergic reactions to monoclonal antibodies
- Serious uncontrolled systemic diseases
- Recent serious infections
- Primary or secondary immunodeficiency unless related to study disease
- Medical or psychological conditions interfering with safe trial completion
- Pregnant or breastfeeding women
- Neuropathies interfering with pain evaluation unless related to study disease
- Lack of peripheral venous access
- Additional exclusions for Cohort B include recent treatment with certain drugs affecting drug metabolism
- Additional exclusions for Cohort C include active or recurrent infections including tuberculosis and viral infections
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Alvin J. Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
U
UCSF HDFCCC Cancer Immunotherapy Program (CIP)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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