Actively Recruiting
An Open-Label Phase II Study of Neoadjuvant Atezolizumab Alone or Combined with Etrumadenant or Tocilizumab in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
Led by David Oh · Updated on 2026-06-04
68
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
David Oh
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well atezolizumab works alone or combined with etrumadenant or tocilizumab in treating men with localized prostate cancer before surgery to remove the prostate (radical prostatectomy). This phase II trial aims to understand how these treatments affect immune cells within tumors, assess safety and tolerability, and explore changes in immune response and the tumor environment. The study also investigates the impact on the gut microbiome and uses new imaging methods to assess treatment effects. Participants are divided into three groups: one receives atezolizumab alone intravenously over 30-60 minutes; another receives atezolizumab plus oral etrumadenant daily until two days before surgery; and the third receives atezolizumab plus intravenous tocilizumab dosed by weight. Each treatment cycle lasts 14 days. Surgery to remove the prostate occurs about 21 days after starting treatment. No additional study treatments are given after surgery. Future groups may include other drug combinations. During the study, participants undergo tumor tissue collection for analysis before treatment. After surgery, follow-up visits occur at 6 weeks, 3 months, 6 months, and 12 months or until disease progression. Researchers monitor treatment effects, immune cell changes, safety, prostate specific antigen (PSA) levels, and pathological responses. The main outcome is the proportion of participants showing a positive response to the therapies within 12 months. Safety and clinical efficacy are closely observed throughout the study period.
CONDITIONS
Brief 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 (no small cell or neuroendocrine cancer)
- Eligible for radical prostatectomy as determined by urologic oncology surgeon and consent to surgery
- Only high-risk patients initially; intermediate-risk may be included after safety review
- Availability of suitable tumor tissue for study analyses
- No prior systemic or local prostate cancer therapies
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate organ and marrow function as defined by specified laboratory values
- Testosterone level greater than 150 ng/dL
- Agreement to use contraception or remain abstinent during treatment and for 4 months after
- Stable anticoagulant 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 on standard staging scans
- Not a candidate for radical prostatectomy as determined by surgeon
- Any prior systemic therapy for prostate cancer, including antiandrogens, chemotherapy, 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 some exceptions
- History of certain lung diseases or pneumonitis
- Prior positive HIV test
- Active hepatitis B or C infection
- Significant cardiovascular disease or recent serious cardiac events
- Active COPD requiring home oxygen or high-dose steroids
- Asthma requiring high-dose systemic steroids
- Recent major surgery or severe infection
- Any condition increasing risk from investigational drug or interfering with study
- Prior allogeneic stem cell or solid organ transplantation
- Recent live vaccine administration
- Recent treatment with investigational therapy or systemic immunostimulatory/suppressive agents
- History of severe allergic reactions to antibodies or study drugs
- Known hypersensitivity to study drug components
- Previous cell-depleting therapies within 5 years
- Previous treatment with tocilizumab (case-by-case exceptions possible)
- Severe uncontrolled comorbid diseases
- Recent serious infections or immunodeficiencies
- Pregnancy or nursing
- Neuropathies interfering with pain evaluation
- Lack of peripheral venous access
- Additional drug interaction exclusions for specific cohorts
- Known active or recurrent infections for cohort C (atezolizumab + tocilizumab) only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive one cycle of neoadjuvant atezolizumab alone or in combination with etrumadenant or tocilizumab prior to radical prostatectomy.
1 visit for drug administration and daily oral dosing for etrumadenant cohort until 48 hours before surgery
Duration - 1 day
Participants undergo radical prostatectomy approximately 21 days after the final dose of atezolizumab.
1 visit (in-person)
Duration - Up to 12 months
Participants are followed for safety, clinical efficacy, and disease progression after surgery.
Visits at 6 weeks, 3 months, 6 months, and 12 months post-surgery
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)
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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