At a glance
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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 Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating 177Lu-PSMA-617, 68Ga-PSMA-11, and 1 other intervention for Prostatic Neoplasms. Active but no longer recruiting, targeting 469 participants across 72 sites in 14 countries.
Detailed Summary
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. 469 participants were randomized (235 in the 177Lu-PSMA-617 group and 234 in the ARDT group.
Study Details
Timeline
Interventions
administered intravenously once every 6 weeks (1 cycle) for 6 cycles
single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi).
administered orally on a continuous basis, as per package insert and guidelines