An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
2 other identifiers
interventional
395
4 countries
47
Brief Summary
Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2014
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2014
CompletedFirst Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2015
CompletedResults Posted
Study results publicly available
April 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2024
CompletedOctober 24, 2025
October 1, 2025
1.4 years
November 13, 2014
December 12, 2016
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Prostate-specific Antigen (PSA) Progression
The time to Prostate Specific Antigen (PSA) progression was defined as the time from randomization to the PSA progression. The PSA progression was defined according to the consensus guidelines of Prostate Cancer Clinical Trials Working Group 2 (PCWG2).For participants with PSA decline at Week 13, the PSA progression date was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which would be confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at Week 13, the PSA progression date was defined as the date when a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later. Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censored.
From the date of randomization to PSA progression median follow-up time is 6.47 months for enzalutamide and 2.99 months for placebo
Secondary Outcomes (15)
Duration of Overall Survival
From the date of randomization to deaths from any cause median follow-up time is 42.32 months for enzalutamide and 26.81 months for placebo
Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment
From the date of randomization to the rPFS event (deaths from any cause and radiographic disease progression) median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo
Time to First Skeletal-Related Event
From the date of randomization to the first skeletal-related event median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo
Time to Initiation of Cytotoxic Chemotherapy
From the date of randomization to initiation of cytotoxic chemotherapy median follow-up time is 7.39 months for enzalutamide and 5.19 months for placebo
Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)
From baseline to the lowest post-baseline PSA result median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo
- +10 more secondary outcomes
Study Arms (3)
Enzalutamide
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Placebo followed by Enzalutamide
EXPERIMENTALEligible 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
CN00103
Beijing, China
CN00104
Beijing, China
CN00106
Beijing, China
CN00111
Beijing, China
CN00112
Beijing, China
CN00114
Beijing, China
CN00115
Beijing, China
CN00127
Beijing, China
CN00121
Changsha, China
CN00107
Hangzhou, China
CN00110
Nanjing, China
CN00117
Nanjing, China
CN00102
Shanghai, China
CN00105
Shanghai, China
CN00108
Shanghai, China
CN00113
Shanghai, China
CN00126
Shanghai, China
CN00119
Suzhou, China
CN00125
Tianjin, China
CN00118
Wenzhou, China
CN00109
Wuhan, China
CN00124
Xi'an, China
HK00402
Hong Kong, Hong Kong
KR00214
Anyang, South Korea
KR00205
Busan, South Korea
KR00207
Busan, South Korea
KR00212
Cheongju-si, South Korea
KR00203
Daegu, South Korea
KR00213
Daejeon, South Korea
KR00201
Incheon, South Korea
KR00202
Seongnam-si, South Korea
KR00204
Seoul, South Korea
KR00206
Seoul, South Korea
KR00208
Seoul, South Korea
KR00209
Seoul, South Korea
KR00210
Seoul, South Korea
KR00211
Seoul, South Korea
KR00215
Seoul, South Korea
TW00309
Kaohsiung City, Taiwan
TW00302
Taichung, Taiwan
TW00303
Taichung, Taiwan
TW00307
Tainan, Taiwan
TW00308
Tainan, Taiwan
TW00301
Taipei, Taiwan
TW00304
Taipei, Taiwan
TW00306
Taipei, Taiwan
TW00305
Taoyuan, Taiwan
Related Publications (1)
Pu YS, Ahn H, Han W, Huang SP, Wu HC, Ma L, Yamada S, Suga K, Xie LP. Enzalutamide in Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer: An Asian Multiregional, Randomized Study. Adv Ther. 2022 Jun;39(6):2641-2656. doi: 10.1007/s12325-022-02140-2. Epub 2022 Apr 10.
PMID: 35397772DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Inc
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 19, 2014
Study Start
April 23, 2014
Primary Completion
September 20, 2015
Study Completion
July 17, 2024
Last Updated
October 24, 2025
Results First Posted
April 12, 2017
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.