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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02003924




Registration number
NCT02003924
Ethics application status
Date submitted
3/12/2013
Date registered
6/12/2013

Titles & IDs
Public title
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
Scientific title
PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Secondary ID [1] 0 0
C3431005
Secondary ID [2] 0 0
MDV3100-14
Universal Trial Number (UTN)
Trial acronym
PROSPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonmetastatic Castration-Resistant 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 - Enzalutamide
Treatment: Drugs - Placebo

Sham comparator: Placebo - Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Experimental: Enzalutamide - 160 mg by mouth once daily


Treatment: Drugs: Enzalutamide
160 mg by mouth once daily

Treatment: Drugs: Placebo
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)
Timepoint [1] 0 0
From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [1] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [1] 0 0
From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [2] 0 0
Time to First Use of New Antineoplastic Therapy
Timepoint [2] 0 0
From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
From randomization until death (up to a maximum of 68.8 months)
Secondary outcome [4] 0 0
Time to Pain Progression
Timepoint [4] 0 0
From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [5] 0 0
Time to First Use of Cytotoxic Chemotherapy
Timepoint [5] 0 0
From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [6] 0 0
Chemotherapy-Free Disease Specific Survival
Timepoint [6] 0 0
From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [7] 0 0
Chemotherapy-Free Survival
Timepoint [7] 0 0
From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [8] 0 0
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Timepoint [8] 0 0
From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [9] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Timepoint [9] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [10] 0 0
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
Timepoint [10] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [11] 0 0
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
Timepoint [11] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [12] 0 0
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
Timepoint [12] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [13] 0 0
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
Timepoint [13] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [14] 0 0
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
Timepoint [14] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [15] 0 0
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
Timepoint [15] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [16] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
Timepoint [16] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [17] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
Timepoint [17] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [18] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
Timepoint [18] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [19] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
Timepoint [19] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [20] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
Timepoint [20] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [21] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
Timepoint [21] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [22] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
Timepoint [22] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [23] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
Timepoint [23] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [24] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39
Timepoint [24] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [25] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40
Timepoint [25] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [26] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41
Timepoint [26] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [27] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42
Timepoint [27] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [28] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43
Timepoint [28] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [29] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44
Timepoint [29] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [30] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45
Timepoint [30] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [31] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46
Timepoint [31] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [32] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47
Timepoint [32] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [33] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48
Timepoint [33] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [34] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49
Timepoint [34] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [35] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50
Timepoint [35] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [36] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51
Timepoint [36] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [37] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52
Timepoint [37] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [38] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53
Timepoint [38] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [39] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54
Timepoint [39] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [40] 0 0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55
Timepoint [40] 0 0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Secondary outcome [41] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [41] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [42] 0 0
Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0
Timepoint [42] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [43] 0 0
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
Timepoint [43] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [44] 0 0
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
Timepoint [44] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [45] 0 0
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry
Timepoint [45] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary outcome [46] 0 0
Number of Participants With Clinically Significant Vital Signs
Timepoint [46] 0 0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
* Testosterone = 50 ng/dL (= 1.73 nmol/L) at screening;
* Progressive disease on androgen deprivation therapy at enrollment;
* PSA and the screening PSA assessed by the central laboratory (central PSA) should be = 2 µg/L (2 ng/mL:
* PSA doubling time = 10 months;
* No prior or present evidence of metastatic disease;
* Asymptomatic prostate cancer;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Estimated life expectancy = 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior cytotoxic chemotherapy;
* Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years of randomization;
* Absolute neutrophil count < 1000/µL, platelet count < 100,000/µL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
* Total bilirubin = 1.5 times the upper limit of normal;
* Creatinine > 2 mg/dL (177 µmol/L) at screening;
* Albumin < 3.0 g/dL (30 g/L) at screening;
* History of seizure or any condition that may predispose to seizure;
* Clinically significant cardiovascular disease;
* Gastrointestinal disorder affecting absorption;
* Major surgery within 4 weeks of randomization;
* Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
* Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

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
31/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
Accrual to date
Final
1402
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [3] 0 0
The Border Cancer Hospital Dispensary - Albury
Recruitment hospital [4] 0 0
The Border Cancer Hospital - Albury
Recruitment hospital [5] 0 0
Sydney cancer centre - Concord
Recruitment hospital [6] 0 0
Epic pharmacy - Lismore
Recruitment hospital [7] 0 0
North Coast Cancer Institute - Lismore
Recruitment hospital [8] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [9] 0 0
Macquarie University - North Ryde
Recruitment hospital [10] 0 0
Epic Pharmacy Port Macquarie base hospital - Port Macquarie
Recruitment hospital [11] 0 0
Mid North Coast Cancer Institute - Port Macquarie
Recruitment hospital [12] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [13] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [14] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [15] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [16] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [17] 0 0
Westmead Hospital - Westmead
Recruitment hospital [18] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [19] 0 0
River City Pharmacy - APHS - Auchenflower
Recruitment hospital [20] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [21] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [22] 0 0
Integrated Clinical Oncology Network (ICON) - South Brisbane
Recruitment hospital [23] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [24] 0 0
Tasman Oncology Research Pty Ltd - Southport
Recruitment hospital [25] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [26] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [27] 0 0
Ashford Cancer Centre Research - Kurralta park
Recruitment hospital [28] 0 0
Cancer Care SA Pty Ltd - Kurralta Park
Recruitment hospital [29] 0 0
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson - Kurralta Park
Recruitment hospital [30] 0 0
Box Hill Hospital (Eastern health) - Box Hill
Recruitment hospital [31] 0 0
Eastern Clinical Research Unit (Eastern Health) - Box Hill
Recruitment hospital [32] 0 0
Cabrini Hospital Brighton - Brighton
Recruitment hospital [33] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [34] 0 0
Austin Health, Austin Hospital - Heidelberg
Recruitment hospital [35] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [36] 0 0
Cabrini Hospital- Education and Research Precinct - Malvern
Recruitment hospital [37] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [38] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2640 - Albury
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2109 - North Ryde
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
4066 - Auchenflower
Recruitment postcode(s) [13] 0 0
4032 - Chermside
Recruitment postcode(s) [14] 0 0
4101 - South Brisbane
Recruitment postcode(s) [15] 0 0
4215 - Southport
Recruitment postcode(s) [16] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [17] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [18] 0 0
5037 - Kurralta park
Recruitment postcode(s) [19] 0 0
3128 - Box Hill
Recruitment postcode(s) [20] 0 0
3186 - Brighton
Recruitment postcode(s) [21] 0 0
3168 - Clayton
Recruitment postcode(s) [22] 0 0
3084 - Heidelberg
Recruitment postcode(s) [23] 0 0
3144 - Malvern
Recruitment postcode(s) [24] 0 0
3000 - Melbourne
Recruitment postcode(s) [25] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa FE
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Argentina
State/province [23] 0 0
La Rioja
Country [24] 0 0
Austria
State/province [24] 0 0
Upper Austria
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Belgium
State/province [26] 0 0
West-vlaanderen
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Gent
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Brazil
State/province [31] 0 0
Bahia
Country [32] 0 0
Brazil
State/province [32] 0 0
Parana
Country [33] 0 0
Brazil
State/province [33] 0 0
RIO Grande DO SUL
Country [34] 0 0
Brazil
State/province [34] 0 0
RJ
Country [35] 0 0
Brazil
State/province [35] 0 0
SAO Paulo
Country [36] 0 0
Brazil
State/province [36] 0 0
SP
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
State/province [41] 0 0
Nova Scotia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Chile
State/province [44] 0 0
Santiago
Country [45] 0 0
Chile
State/province [45] 0 0
Temuco
Country [46] 0 0
Chile
State/province [46] 0 0
Vina del Mar
Country [47] 0 0
China
State/province [47] 0 0
Beijing
Country [48] 0 0
China
State/province [48] 0 0
Chongqing
Country [49] 0 0
China
State/province [49] 0 0
Guangdong
Country [50] 0 0
China
State/province [50] 0 0
Hubei
Country [51] 0 0
China
State/province [51] 0 0
Jiangsu
Country [52] 0 0
China
State/province [52] 0 0
Shandong
Country [53] 0 0
China
State/province [53] 0 0
Shanghai
Country [54] 0 0
China
State/province [54] 0 0
Shanxi
Country [55] 0 0
China
State/province [55] 0 0
Zhejiang
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China
State/province [56] 0 0
Hong Kong
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China
State/province [57] 0 0
Tianjin
Country [58] 0 0
Denmark
State/province [58] 0 0
Norrebro
Country [59] 0 0
Denmark
State/province [59] 0 0
N
Country [60] 0 0
Denmark
State/province [60] 0 0
Arhus N
Country [61] 0 0
Denmark
State/province [61] 0 0
Copenhagen
Country [62] 0 0
Denmark
State/province [62] 0 0
Frederiksberg
Country [63] 0 0
Denmark
State/province [63] 0 0
Herlev
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Denmark
State/province [64] 0 0
Odense C
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Denmark
State/province [65] 0 0
Vejle
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Finland
State/province [66] 0 0
Helsinki
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Finland
State/province [67] 0 0
Oulu
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Finland
State/province [68] 0 0
Pori
Country [69] 0 0
Finland
State/province [69] 0 0
Tampere
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France
State/province [70] 0 0
Alsace
Country [71] 0 0
France
State/province [71] 0 0
Bas-rhin
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France
State/province [72] 0 0
Paris
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France
State/province [73] 0 0
Rhone
Country [74] 0 0
France
State/province [74] 0 0
VAL DE Marne
Country [75] 0 0
France
State/province [75] 0 0
Angers Cedex 2
Country [76] 0 0
France
State/province [76] 0 0
Avignon, Cedex 9
Country [77] 0 0
France
State/province [77] 0 0
Bordeaux Cedex
Country [78] 0 0
France
State/province [78] 0 0
Brest
Country [79] 0 0
France
State/province [79] 0 0
Colmar Cedex
Country [80] 0 0
France
State/province [80] 0 0
Colmar
Country [81] 0 0
France
State/province [81] 0 0
Dijon
Country [82] 0 0
France
State/province [82] 0 0
Le Mans,Cedex
Country [83] 0 0
France
State/province [83] 0 0
Lille
Country [84] 0 0
France
State/province [84] 0 0
Lyon Cedex 03
Country [85] 0 0
France
State/province [85] 0 0
Lyon Cedex
Country [86] 0 0
France
State/province [86] 0 0
Lyon
Country [87] 0 0
France
State/province [87] 0 0
Marseille
Country [88] 0 0
France
State/province [88] 0 0
Montpellier Cedex
Country [89] 0 0
France
State/province [89] 0 0
Paris, Cedex 15
Country [90] 0 0
France
State/province [90] 0 0
Pierre Benite
Country [91] 0 0
France
State/province [91] 0 0
Poitiers, Cedex
Country [92] 0 0
France
State/province [92] 0 0
Saint-Herblain Cedex
Country [93] 0 0
France
State/province [93] 0 0
Toulouse Cedex 3
Country [94] 0 0
France
State/province [94] 0 0
Toulouse Cedex 9
Country [95] 0 0
France
State/province [95] 0 0
Toulouse
Country [96] 0 0
Germany
State/province [96] 0 0
Baden-wuerttemberg
Country [97] 0 0
Germany
State/province [97] 0 0
Baden-wurttemberg
Country [98] 0 0
Germany
State/province [98] 0 0
Niedersachsen
Country [99] 0 0
Germany
State/province [99] 0 0
Nordrhein-westfalen
Country [100] 0 0
Germany
State/province [100] 0 0
Saxony
Country [101] 0 0
Germany
State/province [101] 0 0
Berlin
Country [102] 0 0
Germany
State/province [102] 0 0
Hamburg
Country [103] 0 0
Germany
State/province [103] 0 0
Kirchheim
Country [104] 0 0
Greece
State/province [104] 0 0
Crete
Country [105] 0 0
Greece
State/province [105] 0 0
Athens
Country [106] 0 0
Greece
State/province [106] 0 0
Larissa
Country [107] 0 0
Greece
State/province [107] 0 0
Patra
Country [108] 0 0
Greece
State/province [108] 0 0
Thessaloniki
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Hong Kong
Country [110] 0 0
Hong Kong
State/province [110] 0 0
Shatin
Country [111] 0 0
Italy
State/province [111] 0 0
FC
Country [112] 0 0
Italy
State/province [112] 0 0
Cremona
Country [113] 0 0
Italy
State/province [113] 0 0
Faenza (RA)
Country [114] 0 0
Italy
State/province [114] 0 0
Lugo (RA)
Country [115] 0 0
Italy
State/province [115] 0 0
Meldola (FC)
Country [116] 0 0
Italy
State/province [116] 0 0
Milano
Country [117] 0 0
Italy
State/province [117] 0 0
Modena
Country [118] 0 0
Italy
State/province [118] 0 0
Napoli
Country [119] 0 0
Italy
State/province [119] 0 0
Orbassano (TO)
Country [120] 0 0
Italy
State/province [120] 0 0
Padova
Country [121] 0 0
Italy
State/province [121] 0 0
Ravenna
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Italy
State/province [122] 0 0
Roma
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Italy
State/province [123] 0 0
Trento
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State/province [124] 0 0
Gyeonggi-do
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Korea, Republic of
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Jeonnam
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Korea, Republic of
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Korea, Republic of
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Kuala Lumpur
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Malaysia
State/province [129] 0 0
Sarawak
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Malaysia
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Selangor Darul Ehsan
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AZ
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Netherlands
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Noord-brabant
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Dordrecht
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Groningen
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Netherlands
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Nijmegen
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Canterbury
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New Zealand
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Manawatu
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Poland
State/province [141] 0 0
Gdansk
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Poland
State/province [142] 0 0
Kielce
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Poland
State/province [143] 0 0
Krakow
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Poland
State/province [144] 0 0
Lublin
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Poland
State/province [145] 0 0
Slupsk
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Poland
State/province [146] 0 0
Wroclaw
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Russian Federation
State/province [147] 0 0
Moscow
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Russian Federation
State/province [148] 0 0
Saint-Petersburg
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Russian Federation
State/province [149] 0 0
Ufa
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Serbia
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Belgrade
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Singapore
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
State/province [154] 0 0
Kosice
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Slovakia
State/province [155] 0 0
Martin
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Slovakia
State/province [156] 0 0
Nitra
Country [157] 0 0
Slovakia
State/province [157] 0 0
Presov
Country [158] 0 0
Slovakia
State/province [158] 0 0
Ruzomberok
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Slovakia
State/province [159] 0 0
Skalica
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Slovakia
State/province [160] 0 0
Trnava
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Slovakia
State/province [161] 0 0
Zilina
Country [162] 0 0
Spain
State/province [162] 0 0
A Coruna
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Spain
State/province [163] 0 0
Baleares
Country [164] 0 0
Spain
State/province [164] 0 0
Barcelona
Country [165] 0 0
Spain
State/province [165] 0 0
Cataluna
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Spain
State/province [166] 0 0
Navarra
Country [167] 0 0
Spain
State/province [167] 0 0
Madrid
Country [168] 0 0
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State/province [168] 0 0
Goteborg
Country [169] 0 0
Sweden
State/province [169] 0 0
Malmo
Country [170] 0 0
Sweden
State/province [170] 0 0
Molnlycke
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Sweden
State/province [171] 0 0
Solna
Country [172] 0 0
Sweden
State/province [172] 0 0
Stockholm
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Sweden
State/province [173] 0 0
Umea
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Sweden
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Örebro
Country [175] 0 0
Taiwan
State/province [175] 0 0
Chiayi County
Country [176] 0 0
Taiwan
State/province [176] 0 0
Kaohsiung
Country [177] 0 0
Taiwan
State/province [177] 0 0
Keelung City
Country [178] 0 0
Taiwan
State/province [178] 0 0
Taichung
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Taiwan
State/province [179] 0 0
Tainan City
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taipei
Country [181] 0 0
Taiwan
State/province [181] 0 0
Taoyuan County
Country [182] 0 0
Thailand
State/province [182] 0 0
Chiang MAI
Country [183] 0 0
Thailand
State/province [183] 0 0
Songkla
Country [184] 0 0
Thailand
State/province [184] 0 0
Bangkok
Country [185] 0 0
Turkey
State/province [185] 0 0
Adana
Country [186] 0 0
Turkey
State/province [186] 0 0
Ankara
Country [187] 0 0
Turkey
State/province [187] 0 0
Istanbul
Country [188] 0 0
Turkey
State/province [188] 0 0
Izmir
Country [189] 0 0
Turkey
State/province [189] 0 0
Manisa
Country [190] 0 0
Ukraine
State/province [190] 0 0
Chernivtsi
Country [191] 0 0
Ukraine
State/province [191] 0 0
Dnipropetrovsk
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kharkiv
Country [193] 0 0
Ukraine
State/province [193] 0 0
Kyiv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Uzhgorod
Country [195] 0 0
Ukraine
State/province [195] 0 0
Zaporizhzhia
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Middlesex
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Northern Ireland
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Surrey
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Tyne and Wear
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Birmingham
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Bristol
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Cambridge
Country [203] 0 0
United Kingdom
State/province [203] 0 0
London
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Manchester
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Oxford

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 are available at https://clinicaltrials.gov/study/NCT02003924