The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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)
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
State/province [34] 0 0
Vienna
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussels
Country [36] 0 0
Belgium
State/province [36] 0 0
Ghent
Country [37] 0 0
Belgium
State/province [37] 0 0
Hasselt
Country [38] 0 0
Belgium
State/province [38] 0 0
Kortrijk
Country [39] 0 0
Belgium
State/province [39] 0 0
Leuven
Country [40] 0 0
Belgium
State/province [40] 0 0
Roeselare
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Nova Scotia
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Chile
State/province [46] 0 0
Santiago
Country [47] 0 0
Chile
State/province [47] 0 0
Temuco
Country [48] 0 0
Chile
State/province [48] 0 0
Vina del Mar
Country [49] 0 0
France
State/province [49] 0 0
Angers Cedex 9
Country [50] 0 0
France
State/province [50] 0 0
Bordeaux cedex
Country [51] 0 0
France
State/province [51] 0 0
Caen Cedex
Country [52] 0 0
France
State/province [52] 0 0
Cannes Cedex
Country [53] 0 0
France
State/province [53] 0 0
Creteil
Country [54] 0 0
France
State/province [54] 0 0
Frejus Cedex
Country [55] 0 0
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
Country [59] 0 0
France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Pierre Benite
Country [62] 0 0
France
State/province [62] 0 0
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
State/province [70] 0 0
Aachen
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Braunschweig
Country [73] 0 0
Germany
State/province [73] 0 0
Dresden
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Germany
State/province [75] 0 0
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
State/province [80] 0 0
Modena
Country [81] 0 0
Italy
State/province [81] 0 0
TO
Country [82] 0 0
Italy
State/province [82] 0 0
Cremona
Country [83] 0 0
Italy
State/province [83] 0 0
Rome
Country [84] 0 0
Netherlands
State/province [84] 0 0
Amsterdam
Country [85] 0 0
Netherlands
State/province [85] 0 0
Nijmegen
Country [86] 0 0
Netherlands
State/province [86] 0 0
Rotterdam
Country [87] 0 0
Poland
State/province [87] 0 0
Gdansk
Country [88] 0 0
Poland
State/province [88] 0 0
Grudziadz
Country [89] 0 0
Poland
State/province [89] 0 0
Lodz
Country [90] 0 0
Poland
State/province [90] 0 0
Slupsk
Country [91] 0 0
South Africa
State/province [91] 0 0
Durban
Country [92] 0 0
South Africa
State/province [92] 0 0
Port Elizabeth
Country [93] 0 0
South Africa
State/province [93] 0 0
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
State/province [102] 0 0
Bristol
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Cambridge
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Glasgow
Country [105] 0 0
United Kingdom
State/province [105] 0 0
London
Country [106] 0 0
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.