Howard I. Scher

Howard Scher is one of the foremost clinical trialists in prostate cancer and a central figure in the development of the modern treatment landscape for castration-resistant prostate cancer (CRPC). As Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering and holder of the D. Wayne Calloway Chair in Urologic Oncology, he has led or co-led the pivotal clinical trials that established enzalutamide, cabazitaxel, and multiple other agents as standard-of-care treatments. His career spans four decades of landmark work in both drug development and disease understanding. Scher played a seminal role in the AFFIRM trial (MDV3100-003), the phase 3 study that led to FDA approval of enzalutamide for post-docetaxel CRPC in 2012, and co-led subsequent studies expanding its indications. He has been instrumental in establishing clinical trial endpoints in prostate cancer, particularly advocating for and validating prostate-specific antigen (PSA) response rates, circulating tumor cell (CTC) counts, and overall survival as endpoints — contributions that have shaped FDA guidance for the entire field. His early work on surrogacy of PSA endpoints and proposal of the "Prostate Cancer Working Group" (PCWG) consensus criteria for trial conduct remains foundational. A noted translational researcher, Scher co-developed the AR-V7 circulating tumor cell assay with colleagues to detect the AR splice variant in CTCs, enabling clinical stratification of patients likely to resist enzalutamide and abiraterone. His laboratory has also focused on the biology of bone metastasis and the mechanisms by which prostate cancer cells colonize and remodel the bone microenvironment, leading to novel combination strategies.

Howard Scher 是前列腺癌领域最重要的临床试验专家之一，是现代去势抵抗性前列腺癌（CRPC）治疗体系建立的核心人物。他领导或共同领导了确立恩扎鲁胺、卡巴他赛等多种药物标准治疗地位的关键临床试验，并为整个领域建立了临床试验终点标准。 Scher 在建立 CRPC 临床试验设计标准方面发挥了开创性作用，特别是倡导和验证 PSA 应答率、循环肿瘤细胞（CTC）计数和总生存期作为终点，这些贡献已成为 FDA 指导整个领域的依据。他与同事共同开发了 AR-V7 循环肿瘤细胞检测方法，可检测 CTC 中的 AR 剪接变体，从而实现对可能对恩扎鲁胺和阿比特龙耐药患者的临床分层。