- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer — Active Not Recruiting • Phase III • Oncology • NCT04689828.
- Radioactive lutetium treatment improved survival compared to hormone therapy in men with advanced prostate cancer resistant to standard hormonal treatment.
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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. Conditions: Prostatic Neoplasms Interventions: 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT Lead Sponsor: Novartis Pharmaceuticals Planned Enrollment: 469 participants