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clinical / clinicallutetium-177-PSMA-617 VISION trial, PSMA theranostics, mCRPC radiopharmaceuticals

Michael J. Morris

迈克尔·莫里斯

MD

🏢Memorial Sloan Kettering Cancer Center(纪念斯隆凯特琳癌症中心)🌐USA

Prostate Cancer Section Head, Genitourinary Oncology Service; Professor of Medicine, Weill Cornell Medical College, Memorial Sloan Kettering Cancer Center纪念斯隆凯特琳癌症中心泌尿生殖肿瘤科前列腺癌科主任;威尔康奈尔医学院医学教授

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Key Contributions

👥Biography 个人简介

Michael J. Morris, MD is Prostate Cancer Section Head in the Genitourinary Oncology Service and Professor of Medicine at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College. Dr. Morris is internationally recognized as the leading clinical investigator of PSMA-targeted radioligand therapy in prostate cancer, having been the principal U.S. investigator and steering committee chair for the landmark VISION trial (NEJM 2021), which led to the FDA approval of lutetium-177-PSMA-617 (Pluvicto, 177Lu-PSMA-617) for mCRPC in March 2022 — representing the most significant new treatment modality for prostate cancer in nearly a decade. VISION randomized 831 patients with PSMA-positive mCRPC to 177Lu-PSMA-617 plus standard of care versus standard of care alone, demonstrating significant improvements in rPFS (HR 0.40; p<0.001) and OS (HR 0.62; p<0.001). Beyond VISION, Dr. Morris has been a leader in the broader theranostic field, conducting research on PSMA PET imaging for patient selection and response assessment, combination strategies of 177Lu-PSMA with PARP inhibitors and AR-targeted agents, and the clinical utility of alpha-emitter PSMA-targeted agents (actinium-225-PSMA-617). He has also made foundational contributions to prostate cancer clinical trial design, co-leading FDA qualification of PSA doubling time and circulating tumor cell endpoints, and has been a key investigator in the ALSYMPCA trial of radium-223. Dr. Morris serves on NCCN and ASCO guideline committees for prostate cancer.

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🧪Research Fields 研究领域

VISION Trial — Lutetium-177-PSMA-617 in mCRPC (First PSMA Radioligand Therapy Approval)VISION试验——镥-177-PSMA-617用于mCRPC(首个PSMA放射配体疗法批准)
PSMA Theranostics — PET Imaging and Radioligand Therapy Patient SelectionPSMA诊疗一体化——PET成像与放射配体疗法患者选择
Radium-223 ALSYMPCA in mCRPC Bone Metastases — Co-InvestigatormCRPC骨转移中的镭-223 ALSYMPCA——共同研究员
Prostate Cancer Biomarkers — PSA Kinetics, CTC, ctDNA as Trial Endpoints前列腺癌生物标志物——PSA动力学、CTC与ctDNA作为试验终点
mCRPC Clinical Trial Endpoints — FDA Qualification and Regulatory SciencemCRPC临床试验终点——FDA资质认定与监管科学

🎓Key Contributions 主要贡献

VISION Trial — Lutetium-177-PSMA-617, First PSMA Radioligand Therapy FDA Approval

Served as principal U.S. investigator and steering committee chair of the phase III VISION trial (NEJM 2021) randomizing 831 men with PSMA-positive mCRPC (confirmed by 68Ga-PSMA-11 PET/CT) to 177Lu-PSMA-617 plus standard of care versus standard of care alone. VISION demonstrated: rPFS HR 0.40 (p<0.001); OS HR 0.62 (p<0.001); ORR 51.0% vs. 3.4%. These results led to FDA approval of lutetium-177 vipivotide tetraxetan (Pluvicto) in March 2022 for PSMA-positive mCRPC after AR-targeted therapy and taxane-based chemotherapy — introducing a fundamentally new treatment modality for metastatic prostate cancer.

PSMA Theranostics — PET Imaging, Patient Selection, and Alpha-Emitter Development

Led translational research defining optimal PSMA PET imaging thresholds for patient selection for radioligand therapy, characterizing the clinical and molecular determinants of PSMA expression heterogeneity in mCRPC, and establishing the theranostic principle (treat only patients who are PSMA-PET-positive) for radioligand therapy. Investigated actinium-225-PSMA-617 in early-phase studies for its higher-LET alpha-emitter properties, and designed combination trials evaluating 177Lu-PSMA-617 with PARP inhibitors and enzalutamide to exploit DNA damage response pathway synergies.

Clinical Trial Endpoint Development — PSA Kinetics and CTC Qualification

Led FDA biomarker qualification initiatives at MSK for circulating tumor cell (CTC) count and PSA doubling time as surrogate endpoints in mCRPC clinical trials. Published analyses demonstrating that 12-week CTC conversion (from ≥5 to <5 CTCs/7.5 mL) is associated with OS benefit in multiple mCRPC drug contexts and contributed the CTC evidence package supporting the FDA's Prostate Cancer Working Group (PCWG3) guidance on trial endpoints, standardizing how mCRPC drug development trials are designed.

ALSYMPCA — Radium-223 in mCRPC Bone Metastases

Served as a leading U.S. investigator in the phase III ALSYMPCA trial (NEJM 2013) of radium-223 dichloride versus placebo in mCRPC patients with bone metastases and no known visceral metastases, which demonstrated OS HR 0.70 (p<0.001) and delayed time to first SRE, leading to FDA approval of radium-223 (Xofigo) in 2013. Contributed patient accrual from MSK and expertise in bone-metastatic mCRPC patient selection, and subsequently conducted real-world and post-marketing research on optimal patient selection and sequencing of radium-223.

Representative Works 代表性著作

[1]

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

New England Journal of Medicine (2021)

Landmark VISION phase III trial demonstrating 177Lu-PSMA-617 improved rPFS and OS in PSMA-positive mCRPC, leading to the first FDA approval of PSMA radioligand therapy in prostate cancer.

[2]

Circulating Tumor Cells as Surrogate Endpoint in mCRPC Clinical Trials

Journal of Clinical Oncology (2009)

Demonstration that 12-week CTC conversion is a surrogate for OS in mCRPC, providing the evidentiary basis for CTC qualification as a clinical trial endpoint.

[3]

Alpharadin in Symptomatic Bone Metastases — Radium-223 ALSYMPCA

New England Journal of Medicine (2013)

Phase III ALSYMPCA trial establishing radium-223 OS benefit and reduced SREs in bone-metastatic mCRPC, earning the first FDA approval of a radioactive isotope for prostate cancer.

[4]

Safety and antitumor activity of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer

JAMA Oncology (2018)

U.S. phase II study characterizing safety profile, dosimetry, and PSA response rates of 177Lu-PSMA-617 in heavily pretreated mCRPC patients, establishing the safety database underlying VISION.

🏆Awards & Recognition 奖项与荣誉

🏆ASCO Genitourinary Cancers Symposium Distinguished Service Award
🏆Prostate Cancer Foundation Challenge Award
🏆Society of Nuclear Medicine and Molecular Imaging (SNMMI) Award for Theranostics
🏆Memorial Sloan Kettering Physician-Scientist Award
🏆PCWG3 Consensus Guideline Leadership Recognition

📄Data Sources 数据来源

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

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