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Brief Title: Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).
Official Title: PSMA-directed Targeted Alpha Therapy With FPI-2265 (225Ac-PSMA-I&T) for the Treatment of Metastatic Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.
Study ID: NCT05219500
Brief Summary: The treatment regimen will consist of 4 doses of FPI-2265
Detailed Description: The treatment regimen will consist of 4 doses of FPI-2265, administered at 8 ± 1 week intervals, with an initial activity of 100 kilobecquerel (kBq)/kg (±10%). Additional doses will be administered at 100 kBq/kg (±10%) with the following exceptions: * Participants who experience dose-modifying events. * Participants with a confirmed decline in PSA\>=50%.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
XCancer Omaha/Urology Cancer Center, Omaha, Nebraska, United States
Excel Diagnostics and Nuclear Oncology Center, Houston, Texas, United States
Name: Keith Barnett
Affiliation: Fusion Pharmaceuticals Inc.
Role: STUDY_DIRECTOR