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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
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United States of America
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Alabama
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Arizona
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Michigan
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Minnesota
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Missouri
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Nevada
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New Mexico
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New York
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France
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Pierre Benite
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Muenster
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Tuebingen
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Modena
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TO
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Cremona
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Rome
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Rotterdam
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Poland
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Gdansk
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Grudziadz
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Lodz
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Slupsk
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Durban
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South Africa
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Port Elizabeth
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South Africa
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Sandton
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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United Kingdom
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Middlesex
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Surrey
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Belfast
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Birmingham
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Bristol
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Cambridge
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Glasgow
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London
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Manchester
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Newcastle upon Tyne
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United Kingdom
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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
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT00974311
Trial related presentations / publications
Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.
Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.
Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.
Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.
Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.
Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21. Erratum In: Clin Genitourin Cancer. 2019 Jun;17(3):240. doi: 10.1016/j.clgc.2018.12.008.
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.
Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.
Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.
Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum In: Lancet Oncol. 2014 Oct;15(11):e475.
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.
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/study/NCT00974311