177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Фаза 3
Идёт, набор закрыт
NCT04689828
| Заболевание | Prostatic Neoplasms |
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| Фаза | Фаза 3 |
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| Спонсор | Novartis Pharmaceuticals |
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| Статус | Идёт, набор закрыт |
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| Участники | 469 участн. |
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| Вмешательство | 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT |
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| Дата начала | 15.06.2021 |
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| Дата завершения | 2.10.2022 |
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| Публикация результатов | 9.10.2025 |
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Кратко
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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