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clinical / clinicalradium-223 ALSYMPCA PI, PSMA theranostics, mCRPC bone disease

A. Oliver Sartor

奥利弗·萨托尔

MD

🏢Tulane University School of Medicine / Novartis Institutes for BioMedical Research(杜兰大学医学院 / 诺华生物医学研究所)🌐USA

Medical Director, Tulane Cancer Center; Professor of Medicine and Urology, Tulane University School of Medicine (former); Clinical Development Lead, Oncology (Novartis)杜兰癌症中心医疗主任;杜兰大学医学院医学与泌尿外科教授(前);诺华肿瘤学临床开发主任

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Key Contributions

👥Biography 个人简介

A. Oliver Sartor, MD is among the world's foremost authorities on radiopharmaceutical therapy and bone-targeted treatment of advanced prostate cancer, having spent most of his career as Medical Director of Tulane Cancer Center before joining Novartis Institutes for BioMedical Research. Dr. Sartor is most widely known as the global principal investigator of the landmark ALSYMPCA trial (NEJM 2013), a phase III study of 921 mCRPC patients with symptomatic bone metastases and no known visceral metastases randomized to radium-223 dichloride or placebo. ALSYMPCA demonstrated a significant OS benefit (HR 0.70; p<0.001), reduced time to first SRE, and improved quality of life — the first alpha-particle emitter and the first radiopharmaceutical to improve overall survival in any solid tumor, earning FDA approval of radium-223 (Xofigo) in 2013. Dr. Sartor subsequently became deeply involved in the clinical development of 177Lu-PSMA-617, contributing to VISION trial design, patient accrual, and translational analyses, and is a leading voice on the theranostic paradigm for mCRPC. He has also made foundational contributions to the use of zoledronic acid for SRE prevention, samarium-153-EDTMP for bone pain palliation, and the preclinical and clinical biology of prostate cancer bone disease. Dr. Sartor has authored over 400 peer-reviewed publications and is a frequent keynote speaker at ASCO, APCCC, and EAU on radiopharmaceutical oncology and prostate cancer management.

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🧪Research Fields 研究领域

ALSYMPCA Trial — Principal Investigator, Radium-223 Dichloride in Bone-Metastatic mCRPCALSYMPCA试验——首席研究员,氯化镭-223用于骨转移性mCRPC
PSMA Theranostics — Lutetium-177-PSMA-617 VISION and Global DevelopmentPSMA诊疗一体化——镥-177-PSMA-617 VISION与全球开发
Bone-Targeted Therapy in Prostate Cancer — Radiopharmaceuticals and Mechanisms前列腺癌骨靶向治疗——放射性药物与机制
mCRPC Clinical Trial Design — Endpoints, Patient Selection, and Regulatory SciencemCRPC临床试验设计——终点、患者选择与监管科学
Zoledronic Acid in Prostate Cancer — Skeletal-Related Event Prevention唑来膦酸在前列腺癌中的应用——骨骼相关事件预防

🎓Key Contributions 主要贡献

ALSYMPCA Trial — Global PI, Radium-223 First Alpha-Emitter OS Benefit

Served as global principal investigator of the phase III ALSYMPCA trial (NEJM 2013) randomizing 921 men with symptomatic bone-metastatic mCRPC to radium-223 dichloride (6 monthly injections) or placebo. ALSYMPCA demonstrated OS HR 0.70 (95% CI 0.58–0.83; p<0.001) — median OS 14.9 versus 11.3 months — along with delayed time to first SRE (15.6 vs. 9.8 months; HR 0.66), all with excellent tolerability and no significant myelosuppression at the primary analysis. Radium-223 was FDA-approved in May 2013 as Xofigo — the first alpha-emitting radiopharmaceutical and the first radiopharmaceutical to demonstrate OS benefit in any solid tumor.

PSMA-617 Radioligand Therapy Development and VISION Contribution

Contributed to the global clinical development of 177Lu-PSMA-617, including participation in early-phase safety/efficacy studies and VISION trial design. Provided translational expertise on PSMA biology, optimal patient selection criteria (PSMA-PET positivity thresholds), and safety monitoring. Led post-VISION research on combining 177Lu-PSMA-617 with PARP inhibitors and on next-generation PSMA-targeted agents including actinium-225-PSMA-617 for patients with heterogeneous PSMA expression or post-lutetium progression.

Zoledronic Acid and Bone Health in Advanced Prostate Cancer

Led and participated in pivotal clinical research establishing zoledronic acid (4 mg IV every 3 weeks) as the first agent proven to reduce skeletal-related events in hormone-refractory prostate cancer with bone metastases, contributing to the FDA approval of zoledronic acid for this indication in 2002. Synthesized evidence on optimal dosing frequency (3-weekly vs. 12-weekly), renal safety monitoring, and comparison with denosumab, establishing the bone-protective treatment framework in mCRPC.

mCRPC Clinical Trial Design — Endpoints, Patient Selection, and Regulatory Interface

Co-authored the Prostate Cancer Working Group (PCWG2 and PCWG3) consensus guidelines on clinical trial design in mCRPC, establishing the standardized endpoints (rPFS, PSA progression criteria, SRE composite, CTC), patient selection criteria, and response assessment methodologies that have been adopted as the global standard for regulatory submissions in prostate cancer. These guidelines have directly shaped how dozens of mCRPC pivotal trials have been designed and interpreted.

Representative Works 代表性著作

[1]

Radium-223 Dichloride versus Placebo in Metastatic Castration-Resistant Prostate Cancer (ALSYMPCA)

New England Journal of Medicine (2013)

Landmark ALSYMPCA phase III trial (Sartor as global PI) establishing radium-223 OS benefit in bone-metastatic mCRPC, earning the first-ever OS-based radiopharmaceutical approval in a solid tumor.

[2]

Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer (VISION)

New England Journal of Medicine (2021)

Phase III VISION trial confirming 177Lu-PSMA-617 OS and rPFS benefits in PSMA-positive mCRPC, establishing PSMA radioligand therapy as standard of care.

[3]

Prostate Cancer Working Group 3 (PCWG3) Consensus Guidelines

Journal of Clinical Oncology (2016)

PCWG3 consensus statement standardizing clinical trial endpoints, response criteria, and patient eligibility definitions for mCRPC drug development trials adopted globally by regulatory agencies.

[4]

Zoledronic Acid for Treatment of Osteoporosis and Malignancy-Related Bone Loss

Journal of Clinical Oncology (2004)

Clinical review and analysis establishing the evidence base for zoledronic acid as a standard bone-protective agent in prostate cancer and other malignancy-related bone disease.

🏆Awards & Recognition 奖项与荣誉

🏆ASCO Special Achievement Award in Genitourinary Oncology
🏆American Urological Association Distinguished Contribution to the Art of Urology
🏆Advanced Prostate Cancer Consensus Conference (APCCC) Scientific Committee Leadership
🏆Prostate Cancer Foundation Challenge Award (multiple)
🏆ESMO Award for Radiopharmaceutical Oncology

📄Data Sources 数据来源

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

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