An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

NCT ID: NCT02294461

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-23
• Study Completion Date: 2024-07-17

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.

Detailed Description

The study was a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic participants with progressive metastatic prostate cancer who have disease progression despite androgen deprivation therapy. In order to join the study, participants could not have been previously treated with cytotoxic chemotherapy. Approximately 30 Chinese participants were allocated to the pharmacokinetic (PK) cohort. Participants in the PK cohort were required to be hospitalized from Day 1 before the randomization date to at least the completion of all the assessments planned on Day 3. All participants in the PK cohort underwent blood sampling for the PK analysis. Data reported in the results section was based on data cutoff dates of 20 Sept 2015 for efficacy and safety data and 20 Jan 2016 for PK outcome measures. The study completed double-blind period and is now in the open-label period.

Conditions

Progressive Metastatic Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Oral

Placebo

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral

Placebo followed by Enzalutamide

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.

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Oral

Interventions

Enzalutamide

Oral

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

Other Intervention Names

Xtandi; MDV3100

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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 City, , Taiwan

TW00308

Tainan City, , Taiwan

TW00301

Taipei, , Taiwan

TW00304

Taipei, , Taiwan

TW00306

Taipei, , Taiwan

TW00305

Taoyuan, , Taiwan

Countries

China; Hong Kong; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 35397772 (View on PubMed)

Related Links

https://www.clinicaltrials.astellas.com/study/9785-CL-0232

Link to results and other applicable study documents on the Astellas Clinical Trials website.

https://www.trialsummaries.com/Study/StudyDetails?id=14501&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website.

Other Identifiers

CTR20140131

Identifier Type: REGISTRY

Identifier Source: secondary_id

9785-CL-0232

Identifier Type: -

Identifier Source: org_study_id