177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Phase 3
Active, not recruiting
NCT04689828
| Condition | Prostatic Neoplasms |
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| Phase | Phase 3 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Active, not recruiting |
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| Enrollment | 469 participants |
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| Interventions | 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT |
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| Start date | Jun 15, 2021 |
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| Completion date | Oct 2, 2022 |
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| Results posted | Oct 9, 2025 |
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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.
Radiographic Progression Free Survival (rPFS)
median FU (randomization to event or censoring) 3.65 months (range 0-12.3) · months
| 177Lu-PSMA-617 (AAA617) | 9.30 months |
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| Androgen Receptor-directed Therapy (ARDT) | 5.55 months |
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| p-value | 0.00000001 |
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| Hazard Ratio (HR) | 0.41 (95% CI 0.29–0.56) |
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Open in BENITIONS
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