An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Progressive Metastatic Prostate Cancer
About this trial
This is an interventional treatment trial for Progressive Metastatic Prostate Cancer focused on measuring Enzalutamide, Androgen receptor, Prostate cancer, Xtandi
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
- Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease
- No prior treatment with cytotoxic chemotherapy
- Asymptomatic or mildly symptomatic from prostate cancer
Exclusion Criteria:
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
- Known or suspected brain metastasis or active leptomeningeal disease
- History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
- History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
Sites / Locations
- CN00103
- CN00104
- CN00106
- CN00111
- CN00112
- CN00114
- CN00115
- CN00127
- CN00121
- CN00107
- CN00110
- CN00117
- CN00102
- CN00105
- CN00108
- CN00113
- CN00126
- CN00119
- CN00125
- CN00118
- CN00109
- CN00124
- HK00402
- KR00214
- KR00205
- KR00207
- KR00212
- KR00203
- KR00213
- KR00201
- KR00202
- KR00204
- KR00206
- KR00208
- KR00209
- KR00210
- KR00211
- KR00215
- TW00309
- TW00302
- TW00303
- TW00307
- TW00308
- TW00301
- TW00304
- TW00306
- TW00305
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Enzalutamide
Placebo
Placebo followed by Enzalutamide
Participants received 160 mg of enzalutamide orally once a day during double blind period until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer. Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
Eligible participants who received enzalutamide matching placebo during double-blind period and who provided consent to take part in open-label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.