Natural History of Patients Eligible for PROTEUS Diagnosed with Prostate Cancer and Treated with Radical Prostatectomy Without Perioperative Systemic Treatment

Abstract

The ongoing PROTEUS study aims to evaluate the effectiveness of perioperative Apalutamide combined with androgen-deprivation therapy in improving oncological outcomes for a specifically defined high-risk prostate cancer (PCa) group who were treated with radical prostatectomy (RP). Interestingly, the PROTEUS inclusion criteria did not rely on established risk categories such as the European Association of Urology (EAU) or the National Comprehensive Cancer Network (NCCN) high-risk classification. Consequently, little is known about the natural course of patients eligible for PROTEUS who were diagnosed with high-risk PCa and treated with RP without receiving any neoadjuvant systemic treatment. To address this knowledge gap, this analysis included 701 patients eligible for PROTEUS who have undergone RP, revealing that a significant proportion did not fit into the established high-risk classifications (EAU high-risk: 58.2% and NCCN high-risk: 53.1%). Event-free survival (EFS) rates at 36 and 60 mo of the overall cohort of patients eligible for PROTEUS were 57.6% (95% confidence interval [CI]: 53.9–61.7) and 45.9% (95% CI: 41.9–50.4), respectively. Notably, patients solely eligible for PROTEUS criteria exhibited more favorable EFS rates than those who also met EAU and/or NCCN high-risk criteria. This study highlights the need to enhance treatment strategies for patients with high-risk PCa and suggests potential implications for future research based on PROTEUS data. The results aim to inform clinical practices and the understanding the natural history and its outcomes of patients eligible for PROTEUS who were diagnosed with PCa and underwent RP without neoadjuvant systemic treatment.