Spots Global Cancer Trial Database for Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
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Trial Identification
Brief Title: Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
Official Title: A 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)
Study ID: NCT04647526
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of \[Lu-177\]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).
Detailed Description: The primary objective of the study is to determine the efficacy of \[Lu-177\]-PNT2002 (\[Lu-177\]-PSMA-I\&T) versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC. The study consists of 3 phases: Dosimetry, Randomized Treatment, and Long term Follow up. The study will commence with a 25-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment phase in approximately 390 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either \[Lu-177\]-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B). Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive \[Lu-177\]-PNT2002. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3). Only patients that meet PSMA PET avidity criteria per central review will be eligible for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Institute of Urology (AIU) - Tucson, Tucson, Arizona, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
VA Greater Los Angeles Healthcare System, Los Angeles, California, United States
University of California Los Angeles, Nuclear Medicine Clinic, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Chesapeake Urology Associates (CUA) P.A., Towson, Maryland, United States
University of Michigan Hospitals, Ann Arbor, Michigan, United States
Karmanos Cancer Center, Detroit, Michigan, United States
VA St. Louis Health Care System, Saint Louis, Missouri, United States
Saint Louis University Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Urology Cancer Center, PC, Omaha, Nebraska, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, United States
Tri-State Urologic Services, Cincinnati, Ohio, United States
Greater Dayton Cancer Center, Kettering, Ohio, United States
Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Dallas VA Medical Center, Nuclear Medicine Service, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Excel Diagnostics & Nuclear Oncology Center, Houston, Texas, United States
Swedish Cancer Institute Research, Seattle, Washington, United States
BC Cancer - Vancouver, Vancouver, British Columbia, Canada
Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
London Health Sciences Center - Victoria Hospital, London, Ontario, Canada
Sunnybrook Research Institute, Odette Cancer Center, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CHUM - University Hospital of Montreal, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHU of Quebec - Laval University, Quebec City, Quebec, Canada
Center Jean Perrin, Department of Medical Oncology, Clermont-Ferrand, , France
Claude Huriez Hospital, Lille, , France
Leon Berard Center, Lyon, , France
La Timone Hospital, Nuclear Medicine Department, Marseille, , France
Montpellier Cancer Institute, Department of Nuclear Medicine, Montpellier, , France
Tenon Hospital, Department of Medical Oncology, Paris, , France
St. Antonius Hospital, Nieuwegein, , Netherlands
Radboud University Medical Center (Radboudumc), Nijmegen, , Netherlands
Erasmus University Medical Center Rotterdam, Rotterdam, , Netherlands
Sahlgrenska University Hospital, Gothenburg, , Sweden
Norrlands University Hospital, Department of Radiation Sciences, Oncology, Umea, , Sweden
Charing Cross Hospital, Department of Medical Oncology, London, , United Kingdom
Royal Marsden NHS Foundation Trust - Institute of Cancer Research, Sutton, , United Kingdom
Contact Details
Name: Jessica Jensen
Affiliation: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Role: STUDY_DIRECTOR
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