An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Phase 3
Active, not recruiting
NCT04076059
| Condition | Metastatic Hormone Sensitive Prostate Cancer |
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| Phase | Phase 3 |
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| Sponsor | Astellas (Beijing) Pharmaceutical R&D Co., Ltd. |
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| Status | Active, not recruiting |
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| Enrollment | 180 participants |
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| Interventions | Enzalutamide, Androgen deprivation therapy (ADT) |
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| Start date | Sep 11, 2019 |
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| Completion date | Nov 18, 2022 |
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| Results posted | Nov 18, 2023 |
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Summary
The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC). The study was conducted in two phases: Double-Blind treatment phase and open-label phase.
Time to Prostrate Specific Antigen (PSA) Progression
From the date of randomization to the first observation of PSA progression (up to 38 months) · Months
| Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase) | NA Months |
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| Placebo Plus ADT (Double Blind Phase) | 9.2 Months |
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| p-value | <0.0001 |
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| Cox Proportional Hazard | 0.130 (95% CI 0.076–0.222) |
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Open in BENITIONS
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