OncoMatch/Clinical Trials/NCT03821246
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
Is NCT03821246 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Tocilizumab for prostate adenocarcinoma.
Treatment: Atezolizumab · Tocilizumab · Etrumadenant — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED
Excluded: Stage IV
Eligible for radical prostatectomy as determined by urologic oncology surgeon
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy (antiandrogens, androgen deprivation therapy, gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, chemotherapy, targeted therapy, immunotherapy, radiopharmaceuticals)
Exception: Subjects on finasteride or dutasteride must discontinue and undergo a 6-week washout
Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy [gonadotropin-releasing hormone (GnRH) agonist or antagonist], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study.
Cannot have received: radiotherapy
Prior radiotherapy for PC
Lab requirements
Blood counts
Hemoglobin >= 9 g/dL (no transfusion within 2 weeks); ANC >= 1,500/uL without G-CSF; Absolute lymphocyte count >= 500/uL; Platelets >= 100,000/uL without transfusion; INR or aPTT < 1.5 x ULN for subjects not receiving therapeutic anticoagulation
Kidney function
Creatinine clearance >= 30 mL/min (Cockcroft-Gault); Serum creatinine <=1.6 mg/dL (female) or <=1.9 mg/dL (male); Patients with serum creatinine values exceeding limits may be eligible if estimated GFR >30
Liver function
Total bilirubin < 1.5 x institutional ULN (known Gilbert disease: < 3 x ULN); Alkaline phosphatase < 2 x institutional ULN; AST <= 2 x institutional ULN; ALT <= 2 x institutional ULN
Requirements for organ and marrow function: Hemoglobin >= 9 g/dL; Participants must not have been transfused within 2 weeks prior to screening to meet this criterion; Absolute neutrophil count >= 1,500/microliter (uL) without granulocyte colonystimulating factor support; Absolute lymphocyte count >= 500/uL; Platelets >= 100,000/uL without transfusion; Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: < 3 x ULN); Alkaline phosphatase < 2 x institutional ULN; AST <= 2 x institutional ULN; ALT <= 2 x institutional ULN; INR or aPTT < 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation; Creatinine clearance >= 30 mL/min (Cockcroft-Gault); Serum creatinine <=1.6 mg/dL (female) or <=1.9 mg/dL (male); Patients with serum creatinine values exceeding limits may be eligible if estimated GFR >30
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
- Alvin J. Siteman Cancer Center at Washington University · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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