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

Primary Purpose

Progressive Metastatic Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

Enzalutamide

Placebo

Placebo followed by Enzalutamide

Arm Description

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.

Outcomes

Primary Outcome Measures

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. PSA progression at the time of the data analysis cutoff date could only be declared on or after week 13. Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censored.

Secondary Outcome Measures

Duration of Overall Survival
Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive or data analysis cutoff date, whichever occurred first.
Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment
Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.
Time to First Skeletal-Related Event
Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.
Time to Initiation of Cytotoxic Chemotherapy
Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.
Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)
Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.
Best Overall Soft Tissue Response
Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1.
Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2
Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2
AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2
N is the number of participants with available data at this time point.
Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2
N is the number of participants with available data at this time point.
Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)
Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2
AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Number of Participants With Adverse Events (AE)
The Treatment-Emergent Adverse Events are defined as AEs with a possible or probable relationship to study drug. If participant was still on study drug at the analysis data cutoff date, then the length of the treatment-emergent period was calculated through the cutoff date.

Full Information

First Posted
November 13, 2014
Last Updated
September 15, 2023
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02294461
Brief Title
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2014 (Actual)
Primary Completion Date
September 20, 2015 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Metastatic Prostate Cancer
Keywords
Enzalutamide, Androgen receptor, Prostate cancer, Xtandi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo followed by Enzalutamide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi, MDV3100
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
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. PSA progression at the time of the data analysis cutoff date could only be declared on or after week 13. Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censored.
Time Frame
From randomization up to data cut off date of 20 Sept 2015; median follow-up time is 7.33 months for enzalutamide and 3.02 months for placebo
Secondary Outcome Measure Information:
Title
Duration of Overall Survival
Description
Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive or data analysis cutoff date, whichever occurred first.
Time Frame
From randomization up to data cutoff date of 04 Nov 2020; median follow-up time is 21.9 months for enzalutamide and 7.29 months for placebo
Title
Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment
Description
Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.
Time Frame
From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo
Title
Time to First Skeletal-Related Event
Description
Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.
Time Frame
From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo
Title
Time to Initiation of Cytotoxic Chemotherapy
Description
Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.
Time Frame
From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 4.93 months for placebo
Title
Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)
Description
Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.
Time Frame
Baseline up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo
Title
Best Overall Soft Tissue Response
Description
Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1.
Time Frame
From randomization up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo
Title
Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85
Title
Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85
Title
AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1
Title
Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Description
N is the number of participants with available data at this time point.
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85
Title
Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Description
N is the number of participants with available data at this time point.
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169
Title
Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85
Title
Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85
Title
AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2
Time Frame
From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85
Title
Number of Participants With Adverse Events (AE)
Description
The Treatment-Emergent Adverse Events are defined as AEs with a possible or probable relationship to study drug. If participant was still on study drug at the analysis data cutoff date, then the length of the treatment-emergent period was calculated through the cutoff date.
Time Frame
From first dose of study drug up to data cut off date of 04 Nov. 2020(up to 18.6 months for 'Placebo'; up to 4 weeks after last dose of enzalutamide-up to 84.7 months for 'Enzalutamide' and up to 54.8 months for 'Placebo followed by Enzalutamide')

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
CN00103
City
Beijing
Country
China
Facility Name
CN00104
City
Beijing
Country
China
Facility Name
CN00106
City
Beijing
Country
China
Facility Name
CN00111
City
Beijing
Country
China
Facility Name
CN00112
City
Beijing
Country
China
Facility Name
CN00114
City
Beijing
Country
China
Facility Name
CN00115
City
Beijing
Country
China
Facility Name
CN00127
City
Beijing
Country
China
Facility Name
CN00121
City
Changsha
Country
China
Facility Name
CN00107
City
Hangzhou
Country
China
Facility Name
CN00110
City
Nanjing
Country
China
Facility Name
CN00117
City
Nanjing
Country
China
Facility Name
CN00102
City
Shanghai
Country
China
Facility Name
CN00105
City
Shanghai
Country
China
Facility Name
CN00108
City
Shanghai
Country
China
Facility Name
CN00113
City
Shanghai
Country
China
Facility Name
CN00126
City
Shanghai
Country
China
Facility Name
CN00119
City
Soochow
Country
China
Facility Name
CN00125
City
Tianjin
Country
China
Facility Name
CN00118
City
Wenzhou
Country
China
Facility Name
CN00109
City
Wu Han
Country
China
Facility Name
CN00124
City
Xi'an
Country
China
Facility Name
HK00402
City
Hong Kong
Country
Hong Kong
Facility Name
KR00214
City
Anyang
Country
Korea, Republic of
Facility Name
KR00205
City
Busan
Country
Korea, Republic of
Facility Name
KR00207
City
Busan
Country
Korea, Republic of
Facility Name
KR00212
City
Cheongju
Country
Korea, Republic of
Facility Name
KR00203
City
Daegu
Country
Korea, Republic of
Facility Name
KR00213
City
Daejeon
Country
Korea, Republic of
Facility Name
KR00201
City
Incheon
Country
Korea, Republic of
Facility Name
KR00202
City
Seongnam-si
Country
Korea, Republic of
Facility Name
KR00204
City
Seoul
Country
Korea, Republic of
Facility Name
KR00206
City
Seoul
Country
Korea, Republic of
Facility Name
KR00208
City
Seoul
Country
Korea, Republic of
Facility Name
KR00209
City
Seoul
Country
Korea, Republic of
Facility Name
KR00210
City
Seoul
Country
Korea, Republic of
Facility Name
KR00211
City
Seoul
Country
Korea, Republic of
Facility Name
KR00215
City
Seoul
Country
Korea, Republic of
Facility Name
TW00309
City
Kaohsiung
Country
Taiwan
Facility Name
TW00302
City
Taichung
Country
Taiwan
Facility Name
TW00303
City
Taichung
Country
Taiwan
Facility Name
TW00307
City
Tainan
Country
Taiwan
Facility Name
TW00308
City
Tainan
Country
Taiwan
Facility Name
TW00301
City
Taipei
Country
Taiwan
Facility Name
TW00304
City
Taipei
Country
Taiwan
Facility Name
TW00306
City
Taipei
Country
Taiwan
Facility Name
TW00305
City
Taoyuan County
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
35397772
Citation
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.
Results Reference
derived

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

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