Overview
Genitourinary Cancer: Clinical Trials
Dr. Tagawa leads clinical trials in prostate, renal (kidney), and urothelial (bladder) cancers. The genitourinary section of the solid tumor program includes local, regional, national, and international trials. Weill-Cornell is a main member institution of Cancer and Leukemia Group B (CALGB) and Dr. Tagawa actively participates in the genitourinary section of this national cancer research group. In addition, clinical trials are available through a contract with the National Cancer Institute (NCI) as part of the New York Cancer Consortium.Dr. Tagawa has a specific interest in monoclonal antibody directed therapy, in particular using antibodies against prostate specific membrane antigen (PSMA) and holds grants in this area. He leads clinical trials using radioimmunotherapy (small radioactive particles linked to the antibody) to fight metastatic prostate cancer, to prevent or delay metastatic disease in men with a rising PSA, and targeting tumor vasculature in advanced solid tumors.
Highlights
- 1Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
- 2
- 3Annals of oncology : official journal of the European Society for Medical Oncology · 2024
Publications
265 publications
Funding
26 grantsView NIH portfolio on RePORTER ↗
Active
12 grants- PIHT9425-26-1-E164Targeted TherapiesU.S. Department of Defense · 2026–2030
- PIR50CA285498-03Optimization of strategies to improve NCI-sponsored clinical trial participation throughout the Weill Cornell Medicine - Meyer Cancer Center SphereNational Cancer Institute · 2024–2029
- KPATA 261007-01Theranostic 89Zr/225Ac anti-CEACAM5 radioimmunotherapy for metastatic medullary thyroid cancerAmerican Thyroid Association, Inc. · 2026–2028
- Sub-PIR01CA276269-04Molecular regulation and expression of Trop-2 in advanced prostate cancer: Identifying optimal therapeutic nichesNational Cancer Institute · 2023–2028 · via University of Wisconsin
- Co-IHT9425-25-1-0152Theranostic Trop-2-directed pretargeted radioimmunotherapy for metastatic prostate cancer with curative intentU.S. Department of Defense · 2025–2028
- Co-ICTTRIA-25-1497791-01-CTTRIAFLOW - Flatiron Clinical Pipe™ for Optimized Workflow for Cancer Clinical TrialsAmerican Cancer Society · 2026–2027
- Co-IW81XWH-22-1-0375Clonal Hematopoiesis as a determinant for bone marrow toxicities for targeted radiation therapies in prostate cancer.U.S. Department of Defense · 2022–2027
- PI17CHAL11Optimization of Prostate-Specific Membrane Antigen-Targeted RadiationProstate Cancer Foundation · 2017–2027
- PI24CHAL11Development and optimization of CEACAM5-targeted alpha emittersProstate Cancer Foundation · 2025–2027
- PIW81XWH-22-2-0018Targeted TherapiesU.S. Department of Defense · 2022–2026
- PIW81XWH-20-1-0706Heating cold prostate tumors with PSMA-targeted alpha therapy and pembrolizumabU.S. Department of Defense · 2020–2026
- Sub-PIR44CA285006-01Comprehensive Assessment of Cancer Theranostics ResponseNational Cancer Institute · 2023–2026 · via AIQ Global, Inc.
Completed grants (14)
- MPICCF 234247-01Preclinical Development of Trop2 Directed ImmunoPET Tracer for Prostate Cancer.Conquer Cancer Foundation of the American Society of Clinical Oncology · 2024–2025
- PIW81XWH-18-1-0527Molecular and clinical correlates with prostate-specific membrane antigen (PSMA)-targeted radionuclide therapyU.S. Department of Defense · 2018–2024
- Sub-PI17CHAL05Therapeutic Targeting of AR Variant Prostate Cancer with a Novel Antibody Drug ConjugateProstate Cancer Foundation · 2017–2024 · via University of Wisconsin
- Co-IW81XWH-19-1-0666Transferrin Receptor Identifies a Comprehensive pool of Circulating Tumor Cells with unique molecular features from metastatic Prostate Cancer PatientsU.S. Department of Defense · 2019–2024
- KPASCO 226739-01Radiolabeled PSMA-small molecule and monoclonal antibody J591 for patients with metastatic castration-resistant prostate cancerThe Asco Cancer Foundation · 2023–2024
- Co-IR21EB029649-03The Development of Radiolabeled Positional isomers of [11C]Pyruvate for Imaging Cancer MetabolismNational Institute of Biomedical Imaging and Bioengineering · 2020–2024
- MPIP50CA211024-01A1Weill Cornell Medicine (WCM) SPORE in Prostate CancerNational Cancer Institute · 2017–2023
- Sub-PIW81XWH-20-1-0351Measuring Patient-Reported Outcomes Related to Radiopharmaceuticals for Prostate CancerU.S. Department of Defense · 2020–2023 · via H. Lee Moffitt Cancer Center & Research Institute
- Co-IW81XWH-18-2-0032Prostate Cancer Clinical Consortium Clinical Research Site: Targeted TherapiesU.S. Department of Defense · 2018–2022
- Co-IR01CA207645-03A new technique to make 68Ga-labeled pharmaceuticals widely available for clinical useNational Cancer Institute · 2018–2021
- Co-IR21CA216800-01A1Biomarkers of Taxane Chemotherapy Response/Resistance in Prostate CancerNational Cancer Institute · 2018–2021
- Co-IDU 14111569-01Development of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men With Metastatic CancerProstate Cancer Foundation · 2014–2020 · via Duke University
- PIW81XWH-09-1-0596A Randomized Phase 2 Trial of 177Lu Radiolabeled Anti-PSMA Monoclonal Antibody J591 in Patients with High-Risk Castrate Biochemically Relapsed...U.S. Department of Defense · 2009–2019
- Co-IW81XWH-14-2-0159 YrProstate Cancer Clinical Consortium Clinical Research Site: Targeted TherapiesU.S. Department of Defense · 2014–2018
Clinical research
25 studies
Active
4 studies- PINCT06855277A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate CancerPHASE3 · Novartis Pharma AG · OPEN TO ACCRUAL (as of 2026)Prostate Cancer
- PINCT04946370Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate CancerPHASE1; PHASE2 · Weill Medical College of Cornell University · OPEN TO ACCRUAL (as of 2026)Prostate Cancer
- PINCT04868604A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate CancerPHASE1; PHASE2 · Clarity Pharmaceutical · OPEN TO ACCRUAL (as of 2023)Prostatic Neoplasms, Castration-Resistant
- PIMolecular and Clinical Correlates With Prostate-Specific Membrane Antigen (PSMA) Targeted Radionuclide TherapyWeill Medical College of Cornell University · OPEN TO ACCRUAL (as of 2019)
Completed & closed trials (21)
- PINCT06815354Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform TheranosticsNA · AIQ Global, Inc. · CLOSED TO ACCRUAL (as of 2026)Prostate Cancer
- PINCT05519449A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate CancerPHASE1 · Janux Therapeutics, Inc. · CLOSED TO ACCRUAL (as of 2026)Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
- PINCT02266745A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion CohortsPHASE2 · Phosplatin Therapeutics · IRB STUDY CLOSURE (as of 2026)Advanced Solid Tumors; CRPC; mCRPC; Metastatic Castrate-resistant Prostate Cancer; PT-112; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site
- PIThe Role of Androgen Deprivation as Protection Against Severe Complications from COVID-19Mount Sinai School of Medicine · IRB STUDY CLOSURE (as of 2026)
- PINCT03725761A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed TherapyPHASE2 · University of Wisconsin · IRB STUDY CLOSURE (as of 2026)Prostate Cancer
- PINCT04662580A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate CancerPHASE1 · Janssen Pharmaceutical Company · CLOSED TO ACCRUAL (as of 2025)Metastatic Prostate Cancer
- PINCT04513717Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)PHASE3 · NRG Oncology · CLOSED TO ACCRUAL (as of 2025)Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
- PINCT03547973A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial CancerPHASE2 · Immunomedics, Inc. · IRB STUDY CLOSURE (as of 2025)Metastatic Urothelial Cancer
- PINCT04936230Phase II Randomized Trial of Immunotherapy Versus Immunotherapy and Radiation Therapy for Platinum Ineligible/Refractory Metastatic Urothelial Cancer (IMMORTAL)PHASE2 · Alliance for Clinical Trials in Oncology · IRB STUDY CLOSURE (as of 2025)Metastatic Urothelial Carcinoma; Platinum-Resistant Urothelial Carcinoma; Stage IV Bladder Cancer AJCC v8
- PINCT03682068A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.PHASE3 · AstraZeneca Pharmaceuticals LP · IRB STUDY CLOSURE (as of 2025)Unresectable Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer
- PINCT04600336A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation TherapyPHASE2 · Alliance for Clinical Trials in Oncology · IRB STUDY CLOSURE (as of 2025)Prostate Carcinoma
- PINCT04527991A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial CancerPHASE3 · Immunomedics, Inc. · IRB STUDY CLOSURE (as of 2024)Locally Advanced or Metastatic Unresectable Urothelial Cancer
- PINCT03910660Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases, Administered in Combination With the Anti-Programmed Cell Death 1 Monoclonal Antibody Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma PhenotypePHASE1; PHASE2 · BioXcel Therapeutics, Inc. · IRB STUDY CLOSURE (as of 2024)Prostate Cancer; Neuroendocrine Tumors; Small Cell Carcinoma
- PINCT04576871Pilot Study of PSMA-TRT Re-treatment Utilizing 225Ac-J591EARLY_PHASE1 · Weill Medical College of Cornell University · CLOSED TO ACCRUAL (as of 2024)Prostate Cancer
- PINCT04194554A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate CancerPHASE1; PHASE2 · University of Michigan · CLOSED TO ACCRUAL (as of 2024)Prostate Cancer
- PINCT03792841A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate CancerPHASE1 · Amgen, Inc. · IRB STUDY CLOSURE (as of 2024)Metastatic Castration-resistant Prostate Cancer; Prostate Cancer
- PINCT04647526A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)PHASE3 · POINT Biopharma Inc. · CLOSED TO ACCRUAL (as of 2023)Metastatic Castration-Resistant Prostate Cancer
- PINCT04455750CASPAR - A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-Line Metastatic Castration-Resistant Prostate CancerPHASE3 · Alliance for Clinical Trials in Oncology · CLOSED TO ACCRUAL (as of 2023)Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
- PINCT04720157An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)PHASE3 · Novartis Pharmaceuticals Corporation · CLOSED TO ACCRUAL (as of 2023)Prostatic Neoplasms
- PINCT02365597A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic AlterationsPHASE2 · Janssen Research & Development, LLC · IRB STUDY CLOSURE (as of 2022)Urothelial Cancer
- PINCT00967577177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot StudyPHASE1 · Weill Medical College of Cornell University · CLOSED TO ACCRUAL (as of 2020)Kidney Cancer; Head and Neck Cancer; Breast Cancer; Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer; Ovarian Cancer; Esophageal Cancer; Gliomas
News mentions
2 mentionsView all WCM news ↗
- New Radiopharmaceutical Shows Antitumor Activity in Patients with Advanced Prostate CancerNovember 3, 2023
Researchers at Weill Cornell Medicine have led a phase 1 trial of a new drug that delivers potent radiation therapy directly and specifically to cancer cells in patients with advanced prostate cancer. The clinical trial showed that the “radiopharmaceutical” was well tolerated and demonstrated promising antitumor activity.
- New Treatment Option for Advanced Urothelial Cancer Patients Shows Promise in a Phase 2 Clinical TrialAugust 2, 2021
A new treatment for advanced urothelial cancer was effective with tolerable side effects in an international, multi-center phase 2 clinical trial led by investigators at Weill Cornell Medicine and NewYork-Presbyterian.
Media highlights
7 clips
- New Cancer Drugs Test The Limits Of Care DeliveryAmerican Journal of Managed Care · October 26, 2026
- Targeted Radionuclide Therapy Moves Earlier Across The Cancer Treatment ContinuumOncology Learning Network · October 9, 2026
- How To Decode Your PSMA-PET Scan And Track Your Metastatic Prostate Cancer Treatment ProgressEveryday Health · September 24, 2026
- What Is PSMA Therapy For Metastatic Prostate Cancer?Everyday Health · September 17, 2026
- Navigating Radioligand Therapy Infusion Days And At-Home Radiation Safety For Prostate CancerEveryday Health · September 9, 2026
Show 2 more mentions
- Cadre Of Radiopharmaceuticals Experts Pushes The Bounds In Cancer TherapySTAT · August 31, 2026
- FDA Expands Approval Of Pluvicto In Combination With ARPI For PSMA-Positive mAPMN/S Prostate CancerDiagnostic Imaging · August 3, 2026
Mentoring
2 menteesAll publications with mentees →
- RWRyan WalshMD mentee · Class of 2019
External relationships
Ownership
AIkido Pharma Inc. · Convergent Therapeutics, Inc
Professional Services
UroToday
Proprietary Interest
Convergent Therapeutics, Inc · Gilead Sciences, Inc.
Other
AbbVie Inc. · Abdera Therapeutics INC · AIkido Pharma Inc. · Ambrx, Inc. · Astellas Pharmaceuticals US, Inc. · AstraZeneca, PLC · Bayer Healthcare Pharmaceuticals · Biohaven Pharmaceuticals Inc., · Blue Earth Diagnostics, Inc. · Boston Scientific Corporation · Cancer Research UK · Chugai Pharmaceutical Co., Ltd. · Clarity Pharmaceutical · Clovis Oncology, Inc. · Convergent Therapeutics, Inc · Daiichi Sankyo, Inc. · Dendreon Corporation · Eisai, Inc. · Eli Lilly and Company · EMD Serono, Inc. · Endocyte, Inc. · GE Healthcare · Genentech, Inc. · Gilead Sciences, Inc. · Immunomedics, Inc. · Janssen Biotech Inc. · Karyopharm Therapeutics, Inc. · Lantheus Medical Imaging, Inc. · Merck · Novartis Pharmaceuticals Corporation · Pfizer, Inc. · POINT Biopharma Inc. · QED Therapeutics · Ratio Therapeutics, LLC · Regeneron Pharmaceuticals, Inc. · Sanofi S.A. · Seattle Genetics, Inc. · Telix Pharmaceuticals