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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02003924




Registration number
NCT02003924
Ethics application status
Date submitted
3/12/2013
Date registered
6/12/2013
Date last updated
23/04/2024

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients
with non metastatic prostate cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02003924
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02003924