Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT01212991




Registration number
NCT01212991
Ethics application status
Date submitted
29/09/2010
Date registered
1/10/2010
Date last updated
17/03/2020

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
Recruitment hospital [10] 0 0
SAN Pathology - Wahroonga
Recruitment hospital [11] 0 0
SAN Radiology - Wahroonga
Recruitment hospital [12] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [13] 0 0
Westmead Hospital - Westmead
Recruitment hospital [14] 0 0
Heart Care Partners - Auchenflower
Recruitment hospital [15] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [16] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [17] 0 0
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
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment postcode(s) [8] 0 0
2076 - Sydney
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
4006 - Herston
Recruitment postcode(s) [15] 0 0
4029 - Herston
Recruitment postcode(s) [16] 0 0
4101 - South Brisbane
Recruitment postcode(s) [17] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [18] 0 0
5037 - Kurralta park
Recruitment postcode(s) [19] 0 0
3550 - Bendigo
Recruitment postcode(s) [20] 0 0
3552 - Bendigo
Recruitment postcode(s) [21] 0 0
3128 - Box Hill
Recruitment postcode(s) [22] 0 0
3186 - Brighton
Recruitment postcode(s) [23] 0 0
3168 - Clayton
Recruitment postcode(s) [24] 0 0
3002 - East Melbourne
Recruitment postcode(s) [25] 0 0
3220 - Geelong
Recruitment postcode(s) [26] 0 0
3084 - Heidelberg
Recruitment postcode(s) [27] 0 0
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
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
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
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
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
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
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Austria
State/province [23] 0 0
Salzburg
Country [24] 0 0
Austria
State/province [24] 0 0
Wien
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Ghent
Country [27] 0 0
Belgium
State/province [27] 0 0
Hasselt
Country [28] 0 0
Belgium
State/province [28] 0 0
Kortrijk
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
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Nova Scotia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Denmark
State/province [37] 0 0
Aalborg
Country [38] 0 0
Denmark
State/province [38] 0 0
Aarhus N
Country [39] 0 0
Denmark
State/province [39] 0 0
Copenhagen
Country [40] 0 0
Denmark
State/province [40] 0 0
Frederiksberg
Country [41] 0 0
Denmark
State/province [41] 0 0
Herlev
Country [42] 0 0
Denmark
State/province [42] 0 0
Roskilde
Country [43] 0 0
Finland
State/province [43] 0 0
Helsinki
Country [44] 0 0
Finland
State/province [44] 0 0
Oulu
Country [45] 0 0
Finland
State/province [45] 0 0
Tampere
Country [46] 0 0
France
State/province [46] 0 0
Alsace
Country [47] 0 0
France
State/province [47] 0 0
Bretagne
Country [48] 0 0
France
State/province [48] 0 0
Nouvelle Aquitaine
Country [49] 0 0
France
State/province [49] 0 0
Angers
Country [50] 0 0
France
State/province [50] 0 0
Avignon
Country [51] 0 0
France
State/province [51] 0 0
Bordeaux
Country [52] 0 0
France
State/province [52] 0 0
La Roche sur Yon Cedex
Country [53] 0 0
France
State/province [53] 0 0
Le Mans
Country [54] 0 0
France
State/province [54] 0 0
Lyon
Country [55] 0 0
France
State/province [55] 0 0
Paris Cedex 15
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Saint Herblain Cedex
Country [58] 0 0
France
State/province [58] 0 0
Saint-Mande
Country [59] 0 0
France
State/province [59] 0 0
Saint-Priest en Jarez
Country [60] 0 0
France
State/province [60] 0 0
Toulouse
Country [61] 0 0
France
State/province [61] 0 0
Villejuif
Country [62] 0 0
Germany
State/province [62] 0 0
Niedersachsen
Country [63] 0 0
Germany
State/province [63] 0 0
Berlin
Country [64] 0 0
Germany
State/province [64] 0 0
Braunschweig
Country [65] 0 0
Germany
State/province [65] 0 0
Dresden
Country [66] 0 0
Germany
State/province [66] 0 0
Hamburg
Country [67] 0 0
Germany
State/province [67] 0 0
Heidelberg
Country [68] 0 0
Germany
State/province [68] 0 0
Homburg/Saar
Country [69] 0 0
Germany
State/province [69] 0 0
Mannheim
Country [70] 0 0
Germany
State/province [70] 0 0
Muenster
Country [71] 0 0
Germany
State/province [71] 0 0
Tuebingen
Country [72] 0 0
Germany
State/province [72] 0 0
Ulm
Country [73] 0 0
Germany
State/province [73] 0 0
Weiden In Der Oberpfalz
Country [74] 0 0
Israel
State/province [74] 0 0
Beer Sheva
Country [75] 0 0
Israel
State/province [75] 0 0
Beer Yaakov
Country [76] 0 0
Israel
State/province [76] 0 0
Haifa
Country [77] 0 0
Israel
State/province [77] 0 0
Petach Tikva
Country [78] 0 0
Israel
State/province [78] 0 0
Ramat Gan
Country [79] 0 0
Italy
State/province [79] 0 0
CR
Country [80] 0 0
Italy
State/province [80] 0 0
FC
Country [81] 0 0
Italy
State/province [81] 0 0
TO
Country [82] 0 0
Italy
State/province [82] 0 0
Arezzo
Country [83] 0 0
Italy
State/province [83] 0 0
Forli
Country [84] 0 0
Italy
State/province [84] 0 0
Rome
Country [85] 0 0
Japan
State/province [85] 0 0
Fukuoka
Country [86] 0 0
Japan
State/province [86] 0 0
Kanagawa-ken
Country [87] 0 0
Japan
State/province [87] 0 0
Miyagi
Country [88] 0 0
Japan
State/province [88] 0 0
Nagasaki
Country [89] 0 0
Japan
State/province [89] 0 0
Osaka
Country [90] 0 0
Japan
State/province [90] 0 0
Tokushima
Country [91] 0 0
Japan
State/province [91] 0 0
Tokyo
Country [92] 0 0
Japan
State/province [92] 0 0
Yamaguchi
Country [93] 0 0
Japan
State/province [93] 0 0
Chiba
Country [94] 0 0
Japan
State/province [94] 0 0
Kyoto
Country [95] 0 0
Japan
State/province [95] 0 0
Niigata
Country [96] 0 0
Japan
State/province [96] 0 0
Yamagata
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Gyeonggi-do
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Jeonnam
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Seoul
Country [100] 0 0
Lithuania
State/province [100] 0 0
Klaipeda
Country [101] 0 0
Lithuania
State/province [101] 0 0
Vilnius
Country [102] 0 0
Netherlands
State/province [102] 0 0
Amsterdam
Country [103] 0 0
Netherlands
State/province [103] 0 0
Eindhoven
Country [104] 0 0
Netherlands
State/province [104] 0 0
Groningen
Country [105] 0 0
Netherlands
State/province [105] 0 0
Nijmegen
Country [106] 0 0
Poland
State/province [106] 0 0
Dolnoslaskie
Country [107] 0 0
Poland
State/province [107] 0 0
Lodzkie
Country [108] 0 0
Poland
State/province [108] 0 0
Pomorskie
Country [109] 0 0
Poland
State/province [109] 0 0
Slaskie
Country [110] 0 0
Poland
State/province [110] 0 0
Wielkopolskie
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Moscow
Country [112] 0 0
Russian Federation
State/province [112] 0 0
St-Petersburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
St.-Petersburg
Country [114] 0 0
Singapore
State/province [114] 0 0
Singapore
Country [115] 0 0
Slovakia
State/province [115] 0 0
Banska Bystrica
Country [116] 0 0
Slovakia
State/province [116] 0 0
Bratislava
Country [117] 0 0
Slovakia
State/province [117] 0 0
Martin
Country [118] 0 0
Slovakia
State/province [118] 0 0
Nitra
Country [119] 0 0
Slovakia
State/province [119] 0 0
Presov
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Islas Baleares
Country [122] 0 0
Spain
State/province [122] 0 0
Navarra
Country [123] 0 0
Spain
State/province [123] 0 0
A Coruna
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Sabadell(Barcelona)
Country [126] 0 0
Sweden
State/province [126] 0 0
Gothenburg
Country [127] 0 0
Sweden
State/province [127] 0 0
Malmo
Country [128] 0 0
Sweden
State/province [128] 0 0
Orebro
Country [129] 0 0
Sweden
State/province [129] 0 0
Stockholm
Country [130] 0 0
Sweden
State/province [130] 0 0
Umea
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Middlesex
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Oxfordshire
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Surrey
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Tyne and Wear
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Wales
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Wirral, Merseyside
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Brighton, East Sussex
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Bristol
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Edinburgh
Country [140] 0 0
United Kingdom
State/province [140] 0 0
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
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT01212991
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.
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, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.
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.
Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung D, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.
Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.
Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung D, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.
Kim CS, Choi YD, Lee SE, Lee HM, Ueda T, Yonese J, Fukagai T, Chiong E, Lau W, Abhyankar S, Theeuwes A, Tombal B, Beer TM, Kimura G. Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer. Medicine (Baltimore). 2017 Jul;96(27):e7223. doi: 10.1097/MD.0000000000007223.
Devlin N, Herdman M, Pavesi M, Phung D, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. doi: 10.1186/s12955-017-0704-y.
Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.
Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.
Kim CS, Theeuwes A, Kwon DD, Choi YD, Chung BH, Lee HM, Lee KH, Lee SE. The PREVAIL trial of enzalutamide in men with chemotherapy-naive, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investig Clin Urol. 2016 May;57(3):174-83. doi: 10.4111/icu.2016.57.3.174. Epub 2016 May 10.
Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW, Forer D, Parli T, Phung D, Tombal B, Beer TM, Sternberg CN. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Ann Oncol. 2016 Feb;27(2):286-94. doi: 10.1093/annonc/mdv542. Epub 2015 Nov 16.
Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.
Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01212991