177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
3期
进行中（已停止招募）
NCT04689828
| 适应症 | Prostatic Neoplasms |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Novartis Pharmaceuticals |
|---|
| 状态 | 进行中（已停止招募） |
|---|
| 受试者人数 | 469 人 |
|---|
| 干预（药物） | 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT |
|---|
| 开始日期 | 2021年6月15日 |
|---|
| 完成日期 | 2022年10月2日 |
|---|
| 结果公布日 | 2025年10月9日 |
|---|
摘要
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 |
|---|
| Androgen Receptor-directed Therapy (ARDT) | 5.55 months |
|---|
| p-value | 0.00000001 |
|---|
| Hazard Ratio (HR) | 0.41 (95% CI 0.29–0.56) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。