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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02319837




Registration number
NCT02319837
Ethics application status
Date submitted
14/12/2014
Date registered
18/12/2014

Titles & IDs
Public title
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Scientific title
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Secondary ID [1] 0 0
C3431004
Secondary ID [2] 0 0
MDV3100-13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone Sensitive Prostate Cancer 0 0
Prostate Cancer 0 0
Cancer of the Prostate 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo (No longer applicable in Open Label study period)

Experimental: Enzalutamide plus leuprolide - Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks

Experimental: Enzalutamide monotherapy - Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Active comparator: Leuprolide plus placebo - Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks.

The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.


Treatment: Drugs: Placebo (No longer applicable in Open Label study period)
Sugar pill to mimic enzalutamide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide
Timepoint [1] 0 0
From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Secondary outcome [1] 0 0
Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide
Timepoint [1] 0 0
From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Secondary outcome [2] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [2] 0 0
From randomization until first PSA progression (up to Month 98)
Secondary outcome [3] 0 0
Time to First Use of New Antineoplastic Therapy
Timepoint [3] 0 0
From randomization until first use of new antineoplastic therapy (up to Month 98)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From randomization until death due to any cause (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Secondary outcome [5] 0 0
Time to Distant Metastasis
Timepoint [5] 0 0
From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
Secondary outcome [6] 0 0
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug
Timepoint [6] 0 0
At Week 36
Secondary outcome [7] 0 0
Percentage of Participants Who Remained Treatment-free 2 Years After Suspension of Study Treatment at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
Timepoint [7] 0 0
From randomization until 2 years after Week 37 (up to Month 34)
Secondary outcome [8] 0 0
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA
Timepoint [8] 0 0
From randomization until 2 years after Week 37 (up to Month 34)
Secondary outcome [9] 0 0
Time to Resumption of Any Hormonal Therapy Following Suspension at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
Timepoint [9] 0 0
From treatment suspension at Week 37 until resumption of any hormonal therapy (up to Month 98)
Secondary outcome [10] 0 0
Time to Castration Resistance
Timepoint [10] 0 0
From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone (up to Month 98)
Secondary outcome [11] 0 0
Time to Symptomatic Progression
Timepoint [11] 0 0
From randomization until the first development of events defined as symptomatic progression (up to Month 98)
Secondary outcome [12] 0 0
Time to First Symptomatic Skeletal Event (SSE)
Timepoint [12] 0 0
From randomization until the first development of events defined as SSE (up to Month 98)
Secondary outcome [13] 0 0
Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score
Timepoint [13] 0 0
From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)
Secondary outcome [14] 0 0
Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score
Timepoint [14] 0 0
From randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)
Secondary outcome [15] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (All-causality) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
Timepoint [15] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [16] 0 0
Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023
Timepoint [16] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [17] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Treatment-related) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
Timepoint [17] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [18] 0 0
Number of Participants With SAEs (All-causality) During On-treatment Period, Modified Treatment Period and Treatment Reinitiation Period and SAEs (Treatment-related) During On-treatment period-at PCD Cut-off 31 Jan 2023
Timepoint [18] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [19] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023
Timepoint [19] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [20] 0 0
Number of Participants With Shifts From Grade =2 at Baseline to Grade 3 or Grade 4 Post-baseline in Hematology Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
Timepoint [20] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [21] 0 0
Number of Participants With Shifts From Grade =2 at Baseline to Grade 3 or Grade 4 Post-baseline in Chemistry Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
Timepoint [21] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Secondary outcome [22] 0 0
Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023
Timepoint [22] 0 0
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
* Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
* PSA doubling time = 9 months;
* Screening PSA by the central laboratory = 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
* Serum testosterone = 150 ng/dL (5.2 nmol/L).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
* Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer = 36 months in duration and = 9 months before randomization, or a single dose or a short course (= 6 months) of hormonal therapy given for rising PSA = 9 months before randomization is allowed.;
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
* Major surgery within 4 weeks before randomization;
* Treatment with 5-a reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/09/2026
Actual
Sample size
Target
Accrual to date
Final
1068
Recruitment in Australia
Recruitment state(s)
NSW,NEWQLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Genesis Cancer Care NSW - Gateshead
Recruitment hospital [2] 0 0
Lismore Base hospital - Lismore
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Macquarie University - North Ryde
Recruitment hospital [5] 0 0
Genesis Cancer Care - North Sydney
Recruitment hospital [6] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [7] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [8] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [9] 0 0
Australian Clinical Trials Pty Ltd - Wahroonga
Recruitment hospital [10] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [11] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [12] 0 0
Westmead Hospital - Westmead
Recruitment hospital [13] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [14] 0 0
Crown Princess Mary Cancer Centre - Westmead
Recruitment hospital [15] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [16] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [17] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [18] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [19] 0 0
Icon Cancer Centre Southport - Southport
Recruitment hospital [20] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [21] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [22] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [23] 0 0
Austin Health - Heidelberg
Recruitment hospital [24] 0 0
Australian Urology Associates - Malvern
Recruitment hospital [25] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [26] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2109 - North Ryde
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment postcode(s) [8] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 0 0
2076 - Wahroonga
Recruitment postcode(s) [10] 0 0
2298 - Waratah
Recruitment postcode(s) [11] 0 0
2145 - Westmead
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment postcode(s) [13] 0 0
4066 - Auchenflower
Recruitment postcode(s) [14] 0 0
4032 - Chermside
Recruitment postcode(s) [15] 0 0
4101 - South Brisbane
Recruitment postcode(s) [16] 0 0
4215 - Southport
Recruitment postcode(s) [17] 0 0
5000 - Adelaide
Recruitment postcode(s) [18] 0 0
3128 - Box Hill
Recruitment postcode(s) [19] 0 0
3168 - Clayton
Recruitment postcode(s) [20] 0 0
3084 - Heidelberg
Recruitment postcode(s) [21] 0 0
3144 - Malvern
Recruitment postcode(s) [22] 0 0
3021 - St Albans
Recruitment postcode(s) [23] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Alaska
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Austria
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Upper Austria
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Brazil
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BA
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Brazil
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Parana
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Brazil
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RS
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Brazil
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SP
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British Columbia
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Manitoba
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Canada
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Nova Scotia
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Ontario
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Quebec
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Denmark
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Arhus N
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Copenhagen N
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Denmark
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Copenhagen
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Denmark
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Odense C
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Denmark
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Vejle
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Finland
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Helsinki
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Finland
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Oulu
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Finland
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Pori
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Seinaejoki
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Finland
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Tampere
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Angers cedex 09
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Brest
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LA ROCHE SUR YON cedex 9
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France
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Lille cedex
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France
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Montpellier Cedex 5
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France
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Nantes
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France
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Paris cedex 10
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France
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Paris Cedex 14
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France
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Saint-Gregoire
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France
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Saint-Herblain cedex
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France
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Saint-Mande
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Suresnes
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Villejuif cedex
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France
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Villejuif
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Italy
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Cremona
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Italy
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Faenza RA
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Italy
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Lugo RA
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Italy
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Meldola (FC)
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Italy
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Napoli
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Italy
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Orbassano (TO)
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Italy
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Ravenna
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Italy
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Rimini
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Roma
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Italy
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Trento
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Ede
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Eindhoven
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Groningen
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Leeuwarden
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Maastricht
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Sneek
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Poland
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Gdansk
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Slupsk
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Torun
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Wroclaw
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Presov
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Slovakia
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Zilina
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Barcelona
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Spain
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Islas Baleares
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Spain
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LA Coruna
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Spain
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Cadiz
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Spain
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Girona
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Spain
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Madrid
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Spain
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Manresa
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Spain
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Orense
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Spain
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Sabadell
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Malmo
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Sweden
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Orebro
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [121] 0 0
United Kingdom
State/province [121] 0 0
CITY OF Glasgow
Country [122] 0 0
United Kingdom
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Devon
Country [123] 0 0
United Kingdom
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Greater London
Country [124] 0 0
United Kingdom
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Surrey
Country [125] 0 0
United Kingdom
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WEST Midlands
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Bristol
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Astellas Pharma Inc
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02319837