Spots Global Cancer Trial Database for 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
Official Title: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT05204927
Study Description
Brief Summary: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I\&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.
Detailed Description: This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I\&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer. The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I\&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 6 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment. 30 patients will participate in a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive SPECT imaging after each treatment cycle for dosimetry analysis. Sub-study participants will not be randomized.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Institute of Urology, PPLC, Tucson, Arizona, United States
Providence Medical Foundation, Fullerton, California, United States
Long Beach Memorial Center, Long Beach, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
San Francisco VA Health Care System, San Francisco, California, United States
University of California, San Francisco, San Francisco, California, United States
Providence Saint John's Health Center, Santa Monica, California, United States
GenesisCare USA, Boca Raton, Florida, United States
Biogenix Molecular LLC, Miami, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
GenesisCare USA, Plantation, Florida, United States
Florida Urology Partners, LLP, Tampa, Florida, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
John Hopkins Hospital, Baltimore, Maryland, United States
Kaiser Permanente Gaithersburg Medical Center, Gaithersburg, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
BAMF Health I PC, Grand Rapids, Michigan, United States
Michigan Institute of Urology, Troy, Michigan, United States
GenesisCare USA, Troy, Michigan, United States
M Health Fairview Ridges Cancer Clinic, Burnsville, Minnesota, United States
SSM Saint Louis University Hospital, Saint Louis, Missouri, United States
Center for Clinical Theranostics Research, Washington University, Saint Louis, Missouri, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
XCancer Omaha / Urology Cancer Center, Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Central Ohio Urology Group, Gahanna, Ohio, United States
Hightower Clinical, Oklahoma City, Oklahoma, United States
OHSU - Center for health and healing, Portland, Oregon, United States
VA Portland Health Care System, Portland, Oregon, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Houston Metro Urology, Houston, Texas, United States
Urology San Antonio, San Antonio, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
CHU Brest, Brest, , France
Jean Perrin Comprehensive Cancer Center, Clermont-Ferrand, , France
Institute Paoli-Calmettes, Marseille, , France
Hôpital de Brabois -CHU, Nancy, , France
Institut de Cancérologie de l'Ouest (ICO) St Herblain, Nantes, , France
CHU Nimes, Nîmes, , France
ICANS, Strasbourg, , France
InstitutClaudius Regaud-IUCT-O, Toulouse, , France
University Clinic Bologna, Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milan, , Italy
Istituto Europeo di Oncologia (IEO) -IRCCS, Milan, , Italy
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
University Hospital of Salamanca, Salamanca, , Spain
Contact Details
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