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A phase 3 trial of Enzalutamide in prostate cancer, run by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., active and no longer recruiting.
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) is a phase 3 interventional study registered as NCT04076059 by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., with 180 participants enrolled, started 2019-09-11 and due to reach its primary completion in 2022-11-18. Interventions recorded: Enzalutamide, Placebo, Androgen deprivation therapy (ADT). Conditions listed: Metastatic Hormone Sensitive Prostate Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
180 enrolled.
Not Reached. Data was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication · 95% CI 6.54 to 17.48
SourceNot Reached. Median and upper CI was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication · 95% CI 13.63 to NA
Source95% CI 62.0 to 87.7; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication · 95% CI 59.7 to 94.8
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Time to Prostrate Specific Antigen (PSA) Progressionprimary | Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase) | 120 | Not Reached. Data was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication | - | <0.0001 | link |
| Placebo Plus ADT (Double Blind Phase) | 60 | 9.2 months | ||||
| Radiographic Progression-Free Survival (rPFS) | Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase) | 120 | Not Reached. Median and upper CI was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication | - | <0.0001 | link |
| Placebo Plus ADT (Double Blind Phase) | 60 | 19.4 months | ||||
| Objective Response Rate (ORR) | Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase) | 47 | 76.6% | - | 0.8312 | link |
| Placebo Plus ADT (Double Blind Phase) | 22 | 81.8% |
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Astellas, Metastatic hormone-sensitive prostate cancer, Enzalutamide, Androgen deprivation & AR pathway inhibitors.
Shares Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Metastatic hormone-sensitive prostate cancer, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Metastatic hormone-sensitive prostate cancer, Enzalutamide, Prostate cancer.
Shares Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Metastatic hormone-sensitive prostate cancer, Enzalutamide, Prostate cancer.
Shares Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.