A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
Phase 4
Completed
NCT04108208
| Condition | Prostatic Neoplasms |
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| Phase | Phase 4 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Completed |
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| Enrollment | 75 participants |
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| Interventions | Apalutamide, Androgen-deprivation Therapy (ADT) |
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| Start date | Dec 17, 2019 |
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| Completion date | Jun 1, 2023 |
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| Results posted | Mar 28, 2025 |
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Summary
The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).
Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria
From randomization until first documented PSA progression (up to 3 years 3 months) · Months
| Placebo Plus Androgen-deprivation Therapy (ADT) | NA Months |
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| Apalutamide 240 mg Plus ADT | NA Months |
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| p-value | =0.0052 |
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| Hazard Ratio (HR) | 0.233 (95% CI 0.077–0.705) |
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Open in BENITIONS
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