Phase II Study of Neoadjuvant Atezolizumab Alone or Combined with Etrumadenant or Tocilizumab in Men with Localized Prostate Cancer Before Radical Prostatectomy

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.

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