PSMAfore: A phase III Open-label Multi-Center Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Na ve Men with Progressive Metastatic Castrate Resistant Prostate Cancer

Brief description of study

The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 weeks at a dose of 7.4 GBq improves the radiographic progression free survival or death compared to a change in treatment of androgen receptor-directed therapy (ARTD) in metastatic castrate resistant prostate cancer participants that are previously treated with another ARTD and have not been exposed to taxane-containing regimen. The study drug 177Lu-PSMA-617 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01450
ClinicalTrials.gov Identifier: NCT04689828
Principal Investigator: David R. Wise.


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