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clinical / clinicalenzalutamide community oncology, ARCHES mHSPC, non-metastatic CRPC trials

Neal D. Shore

尼尔·肖尔

MD, FACS

🏢Carolina Urologic Research Center / GenesisCare(卡罗莱纳泌尿学研究中心 / GenesisCare)🌐USA

Medical Director, Carolina Urologic Research Center; Chief Medical Officer, GenesisCare USA; Clinical Professor, Department of Urology, Medical University of South Carolina卡罗莱纳泌尿学研究中心医疗主任;GenesisCare美国首席医疗官;南卡罗来纳医科大学泌尿外科临床教授

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Neal D. Shore, MD, FACS is Medical Director of the Carolina Urologic Research Center and Chief Medical Officer of GenesisCare USA, with a faculty appointment at the Medical University of South Carolina. Dr. Shore is among the most prolific prostate cancer clinical trialists in community-based urology and oncology settings in the United States, having been a principal investigator or steering committee member in over 100 interventional clinical trials in genitourinary malignancies. He is best known for his central role in the ARCHES trial (JCO 2019), a phase III randomized study demonstrating that adding enzalutamide to androgen-deprivation therapy significantly reduced the risk of radiographic progression or death (HR 0.39; p<0.001) in metastatic hormone-sensitive prostate cancer, leading to FDA approval of enzalutamide for mHSPC in 2019. Dr. Shore also participated in the landmark PROSPER trial of enzalutamide in non-metastatic castration-resistant prostate cancer, was involved in early apalutamide (SPARTAN) investigations, and has led research on radium-223, denosumab, and other bone-targeted therapies in the mCRPC bone metastasis setting. His unique contribution has been bridging the gap between academic trial development and community practice implementation, ensuring that practice-changing trials include community oncology and urology sites and reflect real-world patient populations. Dr. Shore serves on multiple NCCN and AUA guideline committees and is a frequent author on prostate cancer treatment guidelines and patient decision-making.

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🧪Research Fields 研究领域

ARCHES Trial — Enzalutamide plus ADT in Metastatic Hormone-Sensitive Prostate CancerARCHES试验——恩扎鲁胺联合ADT用于转移性激素敏感性前列腺癌
Non-Metastatic CRPC (nmCRPC) — Enzalutamide PROSPER, Apalutamide SPARTAN Trials非转移性CRPC(nmCRPC)——PROSPER恩扎鲁胺与SPARTAN阿帕鲁胺试验
Community Oncology Drug Development — Pragmatic Prostate Cancer Trial Design社区肿瘤学药物开发——实用性前列腺癌试验设计
Prostate Cancer in the Community Setting — Real-World Treatment Patterns社区医疗中的前列腺癌——真实世界治疗模式
Radium-223 and Bone-Targeted Therapies in mCRPC Bone Metastases镭-223与骨靶向治疗在mCRPC骨转移中的应用

🎓Key Contributions 主要贡献

ARCHES Trial — Enzalutamide plus ADT in mHSPC

Served as a principal investigator and steering committee member of the phase III ARCHES trial (JCO 2019), randomizing 1,150 men with metastatic hormone-sensitive prostate cancer to enzalutamide plus ADT versus placebo plus ADT. ARCHES demonstrated a radiographic PFS HR of 0.39 (p<0.001) at primary analysis, with updated OS data (NEJM Evidence 2022) confirming a significant OS benefit (HR 0.66; p=0.0007). This trial contributed to FDA approval of enzalutamide for mHSPC in December 2019, establishing a second AR-pathway intensification option alongside abiraterone for mHSPC management.

PROSPER Trial — Enzalutamide in Non-Metastatic CRPC

Participated in the phase III PROSPER trial of enzalutamide versus placebo in non-metastatic castration-resistant prostate cancer (PSA doubling time ≤10 months), which demonstrated a metastasis-free survival benefit of 21.9 versus 14.7 months (HR 0.29; p<0.001) and a subsequent OS benefit (HR 0.73; p=0.001). Contributed community urology sites and patient accrual, ensuring that this practice-changing trial reflected the population of high-risk nmCRPC patients typically managed in non-academic community settings.

Community Oncology Trial Infrastructure — Bridging Academic and Real-World Practice

Built and directs the Carolina Urologic Research Center as one of the highest-enrolling community-based genitourinary oncology research centers in the United States, conducting over 100 interventional clinical trials. Demonstrated that community urology practices can successfully execute complex randomized phase III trials with rigorous protocol adherence, expanding trial access to underrepresented rural and community patient populations and accelerating accrual to practice-changing prostate cancer studies.

Bone-Targeted Therapies in mCRPC — Radium-223 and Denosumab Real-World Data

Led clinical research and real-world registry analyses characterizing the use and outcomes of radium-223 dichloride (Xofigo) and denosumab in mCRPC patients with bone metastases in community practice settings, identifying patient selection predictors, optimal sequencing with AR-targeted agents, and safety profiles outside of controlled trial environments, thereby bridging the gap between pivotal trial results and community practice standards.

Representative Works 代表性著作

[1]

Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer (ARCHES)

Journal of Clinical Oncology (2019)

Phase III ARCHES trial establishing enzalutamide plus ADT superiority over ADT alone in mHSPC, expanding AR intensification to the hormone-sensitive setting and earning FDA approval.

[2]

Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer (PROSPER)

New England Journal of Medicine (2018)

Phase III PROSPER trial demonstrating enzalutamide significantly delayed metastasis and death in high-risk nmCRPC, establishing a new standard of care for biochemically relapsed CRPC without detectable metastases.

[3]

Radium-223 dichloride and abiraterone acetate safety run-in preceding the phase 3 ERA 223 trial

European Urology (2019)

Safety and pharmacokinetic evaluation of the radium-223 and abiraterone combination informing ERA 223 trial design and eventual combination therapy guidance.

[4]

Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer (TITAN)

New England Journal of Medicine (2019)

Phase III TITAN trial of apalutamide plus ADT in mHSPC demonstrating improved rPFS and OS, contributing to the expanding toolkit of AR-targeted intensification strategies in metastatic hormone-sensitive disease.

🏆Awards & Recognition 奖项与荣誉

🏆AUA Gold Cystoscope Award
🏆Society of Urologic Oncology Distinguished Service Award
🏆Prostate Cancer Foundation Challenge Award
🏆ASCO Community Oncology Research Award
🏆Large Urology Group Practice Association (LUGPA) Innovation Award

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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