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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00974311




Registration number
NCT00974311
Ethics application status
Date submitted
9/09/2009
Date registered
10/09/2009
Date last updated
11/12/2018

Titles & IDs
Public title
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Scientific title
Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
Secondary ID [1] 0 0
2009-013174-41
Secondary ID [2] 0 0
CRPC2
Universal Trial Number (UTN)
Trial acronym
AFFIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant 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 - Formerly MDV3100

Placebo comparator: Placebo -


Treatment: Drugs: Enzalutamide
MDV3100, 160 mg orally per day

Treatment: Drugs: Placebo
Placebo comparator
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 101 months)
Secondary outcome [1] 0 0
Radiographic Progression-free Survival
Timepoint [1] 0 0
During DB phase (up to 24 months)
Secondary outcome [2] 0 0
Time to First Skeletal-related Event
Timepoint [2] 0 0
During DB Phase (up to 24 months)
Secondary outcome [3] 0 0
Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Timepoint [3] 0 0
Baseline up to 24 months
Secondary outcome [4] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [4] 0 0
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Secondary outcome [5] 0 0
Percentage of Participants With Pain Palliation
Timepoint [5] 0 0
Baseline up to 24 months
Secondary outcome [6] 0 0
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Timepoint [6] 0 0
During DB phase (up to 24 months)
Secondary outcome [7] 0 0
Percentage of Participants With Soft-tissue Objective Response
Timepoint [7] 0 0
During DB phase (up to 24 months)
Secondary outcome [8] 0 0
European Quality of Life Five-Domain (EQ-5D) Scale
Timepoint [8] 0 0
Week 13
Secondary outcome [9] 0 0
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
Timepoint [9] 0 0
Baseline up to 24 months

Eligibility
Key inclusion criteria
* Progressive prostate cancer
* Medical or surgical castration with testosterone less than 50 ng/dl
* One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow, hepatic, and renal function
* Able to swallow the study drug and comply with study requirements
* Informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Metastases in the brain or active epidural disease
* Another malignancy within the previous 5 years
* Clinically significant cardiovascular disease
* Gastrointestinal disorder affecting absorption

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
30/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2017
Sample size
Target
Accrual to date
Final
1199
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
North Coast Cancer Institute - Coffs Harbour
Recruitment hospital [2] 0 0
Sydney Cancer Centre - Concord
Recruitment hospital [3] 0 0
Mid North Coast Diagnostic Imaging - Port Macquarie
Recruitment hospital [4] 0 0
Port Macquarie Base Hospital Pharmacy - Port Macquarie
Recruitment hospital [5] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [6] 0 0
Prince of Wales Hospital, Department of Medical Oncology - Randwick
Recruitment hospital [7] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [8] 0 0
PRP Diagnostic Imaging - Wentworthville
Recruitment hospital [9] 0 0
Sydney West Cancer Trials Centre, Department of Medical Oncology - Westmead
Recruitment hospital [10] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [11] 0 0
Heart Care Partners - Auchenflower
Recruitment hospital [12] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [13] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [14] 0 0
Southern X-Ray Chermside - Chermside
Recruitment hospital [15] 0 0
Cancer Care Services - Herston
Recruitment hospital [16] 0 0
Icon Cancer Foundation - Milton
Recruitment hospital [17] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [18] 0 0
Mater Private Cardiology - South Brisbane
Recruitment hospital [19] 0 0
Queensland X-Ray - South Brisbane
Recruitment hospital [20] 0 0
XRadiology - Toowong
Recruitment hospital [21] 0 0
Department of Medical Oncology - Adelaide
Recruitment hospital [22] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [23] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [24] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [25] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [26] 0 0
Sir Charles Gairdner Hospital, Department of Medical Oncology - Nedlands
Recruitment hospital [27] 0 0
60 Eleanor St - Footscray
Recruitment hospital [28] 0 0
Western Hospital - Footscray
Recruitment hospital [29] 0 0
The Royal Melbourne Hospital - Victoria
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [6] 0 0
2145 - Wentworthville
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4064 - Auchenflower
Recruitment postcode(s) [9] 0 0
4066 - Auchenflower
Recruitment postcode(s) [10] 0 0
4032 - Chermside
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
4064 - Milton
Recruitment postcode(s) [13] 0 0
4101 - South Brisbane
Recruitment postcode(s) [14] 0 0
4066 - Toowong
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
7000 - Hobart
Recruitment postcode(s) [17] 0 0
3065 - Fitzroy
Recruitment postcode(s) [18] 0 0
3199 - Frankston
Recruitment postcode(s) [19] 0 0
3084 - Heidelberg
Recruitment postcode(s) [20] 0 0
6009 - Nedlands
Recruitment postcode(s) [21] 0 0
3011 - Footscray
Recruitment postcode(s) [22] 0 0
3050 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
AR
Country [28] 0 0
Argentina
State/province [28] 0 0
Provincia DE Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
Provincia DE Neuquen
Country [30] 0 0
Argentina
State/province [30] 0 0
Provincia DE RIO Negro
Country [31] 0 0
Argentina
State/province [31] 0 0
Provincia DE Santa FE
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autonoma de Buenos Aires
Country [33] 0 0
Austria
State/province [33] 0 0
Linz
Country [34] 0 0
Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Ghent
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Belgium
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Hasselt
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
State/province [41] 0 0
Alberta
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Canada
State/province [42] 0 0
British Columbia
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Canada
State/province [43] 0 0
Nova Scotia
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Canada
State/province [44] 0 0
Ontario
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Canada
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Quebec
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Vina del Mar
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France
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Angers Cedex 9
Country [50] 0 0
France
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Bordeaux cedex
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France
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Caen Cedex
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France
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Cannes Cedex
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France
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Creteil
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France
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Frejus Cedex
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France
State/province [55] 0 0
LA Roche sur Yon
Country [56] 0 0
France
State/province [56] 0 0
Le Mans
Country [57] 0 0
France
State/province [57] 0 0
Lyon Cedex 08
Country [58] 0 0
France
State/province [58] 0 0
Lyon Cedex 3
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France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
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Paris
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France
State/province [61] 0 0
Pierre Benite
Country [62] 0 0
France
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Poitiers Cedex
Country [63] 0 0
France
State/province [63] 0 0
Reims Cedex
Country [64] 0 0
France
State/province [64] 0 0
Saint Etienne Cedex 2
Country [65] 0 0
France
State/province [65] 0 0
Saint Priest en Jarez
Country [66] 0 0
France
State/province [66] 0 0
Saint-Etienne CEDEX 2
Country [67] 0 0
France
State/province [67] 0 0
SAINT-HERBLAIN Cedex
Country [68] 0 0
France
State/province [68] 0 0
Suresnes Cedex
Country [69] 0 0
France
State/province [69] 0 0
Villejuif
Country [70] 0 0
Germany
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Aachen
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Germany
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Berlin
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Germany
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Braunschweig
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Germany
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Dresden
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Germany
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Hamburg
Country [75] 0 0
Germany
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Hannover
Country [76] 0 0
Germany
State/province [76] 0 0
Heidelberg
Country [77] 0 0
Germany
State/province [77] 0 0
Mannheim
Country [78] 0 0
Germany
State/province [78] 0 0
Muenster
Country [79] 0 0
Germany
State/province [79] 0 0
Tuebingen
Country [80] 0 0
Italy
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Modena
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Italy
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TO
Country [82] 0 0
Italy
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Cremona
Country [83] 0 0
Italy
State/province [83] 0 0
Rome
Country [84] 0 0
Netherlands
State/province [84] 0 0
Amsterdam
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Netherlands
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Nijmegen
Country [86] 0 0
Netherlands
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Rotterdam
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Poland
State/province [87] 0 0
Gdansk
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Poland
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Grudziadz
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Poland
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Lodz
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Poland
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Slupsk
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South Africa
State/province [91] 0 0
Durban
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South Africa
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Port Elizabeth
Country [93] 0 0
South Africa
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Sandton
Country [94] 0 0
Spain
State/province [94] 0 0
Badalona
Country [95] 0 0
Spain
State/province [95] 0 0
Barcelona
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Pamplona
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Middlesex
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Surrey
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Belfast
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Birmingham
Country [102] 0 0
United Kingdom
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Bristol
Country [103] 0 0
United Kingdom
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Cambridge
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Glasgow
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United Kingdom
State/province [105] 0 0
London
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United Kingdom
State/province [106] 0 0
Manchester
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Newcastle upon Tyne
Country [108] 0 0
United Kingdom
State/province [108] 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

No information has been provided regarding IPD availability


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/NCT00974311