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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01212991




Registration number
NCT01212991
Ethics application status
Date submitted
29/09/2010
Date registered
1/10/2010

Titles & IDs
Public title
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Scientific title
PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Secondary ID [1] 0 0
2010-020821-41
Secondary ID [2] 0 0
MDV3100-03
Universal Trial Number (UTN)
Trial acronym
PREVAIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 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

Experimental: Enzalutamide -

Placebo comparator: Placebo -


Treatment: Drugs: Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.

Treatment: Drugs: Placebo
Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
During study period (up to 3 years)
Primary outcome [2] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [2] 0 0
During study period (up to 20 months)
Secondary outcome [1] 0 0
Time to First Skeletal-related Event
Timepoint [1] 0 0
During study period (up to 3 years)
Secondary outcome [2] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [2] 0 0
During study period (up to 3 years)
Secondary outcome [3] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [3] 0 0
During study period (up to 3 years)
Secondary outcome [4] 0 0
Percentage of Patients With Prostate Specific Antigen (PSA) Response = 50%
Timepoint [4] 0 0
During study period (up to 3 years)
Secondary outcome [5] 0 0
Best Overall Soft Tissue Response
Timepoint [5] 0 0
During study period (up to 3 years)

Eligibility
Key inclusion criteria
Randomized, Double Blind Treatment Period:



* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
* Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
* No prior treatment with cytotoxic chemotherapy
* Asymptomatic or mildly symptomatic from prostate cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease
* History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.

Eligible patients must meet all inclusion criteria.

* Received randomized double-blind treatment in PREVAIL;
* Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
* Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:

* Has taken commercially available enzalutamide (Xtandi);
* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease

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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/02/2019
Sample size
Target
Accrual to date
Final
1717
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [3] 0 0
Lismore Base Hospital, Lismore Cancer Care and Haematology Unit - Lismore
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
North Coast Cancer Institute - Port Macquarie
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital, Department of Medical Oncology - St Leonards
Recruitment hospital [8] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [9] 0 0
Australian Clinical Trials Pty Ltd - Wahroonga
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SAN Pathology - Wahroonga
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SAN Radiology - Wahroonga
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Calvary Mater Newcastle - Waratah
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Westmead Hospital - Westmead
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Heart Care Partners - Auchenflower
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Icon Cancer Care Wesley - Auchenflower
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River City Pharmacy - Auchenflower
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Icon Cancer Care Chermside - Chermside
Recruitment hospital [18] 0 0
University of Queensland Centre for Clinical Research (UQCCR) - Herston
Recruitment hospital [19] 0 0
Nuclear Medicine and Imaging Department - Herston
Recruitment hospital [20] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [21] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [22] 0 0
Mater Private Cardiology - South Brisbane
Recruitment hospital [23] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [24] 0 0
APHS Pharmacy - Kurralta Park
Recruitment hospital [25] 0 0
Ashford Cancer Centre Research - Kurralta park
Recruitment hospital [26] 0 0
Cancer Care SA Pty Ltd - Kurralta Park
Recruitment hospital [27] 0 0
Bendigo Health, Bendigo Hospital - Bendigo
Recruitment hospital [28] 0 0
Bendigo Health Medical Imaging - Bendigo
Recruitment hospital [29] 0 0
Eastern Health - Box Hill
Recruitment hospital [30] 0 0
MIA Box Hill Radiology - Box Hill
Recruitment hospital [31] 0 0
Oncology Eastern Clinical Research Unit (ECRU) - Box Hill
Recruitment hospital [32] 0 0
Pharmacy Department - Box Hill
Recruitment hospital [33] 0 0
Cabrini Hospital Brighton - Brighton
Recruitment hospital [34] 0 0
Monash Health Translation Precinct - Clayton
Recruitment hospital [35] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [36] 0 0
Barwon Health, Geelong Hospital - Geelong
Recruitment hospital [37] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [38] 0 0
Cabrini Hospital Malvern - Malvern,
Recruitment hospital [39] 0 0
Cabrini Radiology - Malvern
Recruitment hospital [40] 0 0
MDI Chemer - Malvern
Recruitment hospital [41] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [42] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2139 - Concord
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2217 - Kogarah
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2480 - Lismore
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2170 - Liverpool
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2444 - Port Macquarie
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2031 - Randwick
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2065 - St Leonards
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2076 - Sydney
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2076 - Wahroonga
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2298 - Waratah
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2145 - Westmead
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4066 - Auchenflower
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4032 - Chermside
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4006 - Herston
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4029 - Herston
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4101 - South Brisbane
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5037 - Kurralta Park
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5037 - Kurralta park
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3550 - Bendigo
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3552 - Bendigo
Recruitment postcode(s) [21] 0 0
3128 - Box Hill
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3186 - Brighton
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3168 - Clayton
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3002 - East Melbourne
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3220 - Geelong
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3084 - Heidelberg
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3144 - Malvern,
Recruitment postcode(s) [28] 0 0
3144 - Malvern
Recruitment postcode(s) [29] 0 0
3000 - Melbourne
Recruitment postcode(s) [30] 0 0
3021 - St Albans
Recruitment outside Australia
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United States of America
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Arizona
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Michigan
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Minnesota
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Missouri
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Nebraska
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Wisconsin
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Austria
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Linz
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Homburg/Saar
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London

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 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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01212991