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A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)
This study is currently recruiting participants.
Verified February 2012 by Medivation, Inc.

First Received on September 29, 2010.   Last Updated on February 27, 2012   History of Changes
Sponsor: Medivation, Inc.
Collaborator: Astellas Pharma Inc
Information provided by: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01212991
  Purpose

The purpose of this study is to determine the benefit of MDV3100 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.


Condition Intervention Phase
Prostate Cancer
 Drug: MDV3100
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Overall Survival
  • Progression-free Survival

Secondary Outcome Measures:
  • Time to first skeletal-related event
  • Time to initiation of cytotoxic chemotherapy

Estimated Enrollment: 1680
Study Start Date: September 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212991

Contacts
Contact: William Novotny, MD 855-977-3825 info@PrevailTrial.com
Contact: Craig Berman, MD 855-977-3825 info@PrevailTrial.com

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Active, not recruiting
Tuscon, Arizona, United States, 85724
United States, California
Active, not recruiting
Los Angeles, California, United States, 90024
Recruiting
Los Angeles, California, United States, 90033
Recruiting
Sacramento, California, United States, 95817
Active, not recruiting
San Diego, California, United States, 92123
Active, not recruiting
Stanford, California, United States, 94305
United States, Florida
Active, not recruiting
Boca Raton, Florida, United States, 33486
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Kentucky
Active, not recruiting
Louisville, Kentucky, United States, 40245
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
Active, not recruiting
Omaha, Nebraska, United States, 68114
United States, New York
Active, not recruiting
New York, New York, United States, 11201
Active, not recruiting
New York, New York, United States, 10029
United States, North Carolina
Active, not recruiting
Cary, North Carolina, United States, 27518
Active, not recruiting
Durham, North Carolina, United States, 27710
Active, not recruiting
Raleigh, North Carolina, United States, 27607
United States, Oregon
Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Active, not recruiting
Dallas, Texas, United States, 75235
United States, Virginia
Active, not recruiting
Newport News, Virginia, United States, 23502
United States, Washington
Active, not recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
Active, not recruiting
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Recruiting
Concord, New South Wales, Australia
Recruiting
Kogarah, New South Wales, Australia
Recruiting
Lismore, New South Wales, Australia
Recruiting
Liverpool, New South Wales, Australia
Recruiting
Port Macquarie, New South Wales, Australia
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Randwick, New South Wales, Australia
Recruiting
Wahroonga, New South Wales, Australia
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Watarah, New South Wales, Australia
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Westmead, New South Wales, Australia
Australia, Queensland
Recruiting
Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
Australia, South Australia
Recruiting
Kurralta Park, South Australia, Australia
Australia, Victoria
Recruiting
Bendigo, Victoria, Australia
Recruiting
Box Hill, Victoria, Australia
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East Melbourne, Victoria, Australia
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Footscray, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
Australia
Recruiting
New South Wales, Australia
Austria
Recruiting
Wien, Vienna, Austria
Recruiting
Graz, Austria
Recruiting
Linz, Austria
Recruiting
Salzburg, Austria
Recruiting
Wien, Austria
Belgium
Recruiting
Bruxelles, Belgium
Recruiting
Gent, Belgium
Recruiting
Hasselt, Belgium
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Kortrijk, Belgium
Recruiting
Leuven, Belgium
Recruiting
Liege, Belgium
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Roeselare, Belgium
Canada, Alberta
Recruiting
Calgary, Alberta, Canada
Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Recruiting
Victoria, British Columbia, Canada
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
Recruiting
Toronto, Ontario, Canada, M4N 3M5
Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H2L 4M
Recruiting
Quebec City, Quebec, Canada, G1R 3S3
Recruiting
Sherbrooke, Quebec, Canada
Denmark
Recruiting
Aalborg, Denmark
Recruiting
Aarhus, Denmark
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Copenhagen, Denmark
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Frederiksberg, Denmark
Recruiting
Herlev, Denmark
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Roskilde, Denmark
Finland
Recruiting
Helsinki, Finland
Recruiting
Oulu, Finland
Recruiting
Tampere, Finland
France
Recruiting
Angers, France
Recruiting
Avignon, France
Recruiting
Bordeaux, France
Recruiting
Bordeaux, France, 33075
Recruiting
La Roche sur Yon, France
Recruiting
Le Mans, France
Recruiting
Lyon, France
Recruiting
Paris, France
Recruiting
Paris, France, 75475
Recruiting
Paris Cedex 15, France
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Rennes, France
Recruiting
Saint Herblain, France
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Saint Priest en Jarez, France
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Villejuif, France
Germany
Recruiting
Berlin, Germany, 12203
Recruiting
Braunschweig, Germany
Recruiting
Dresden, Germany
Recruiting
Hamburg, Germany, 20246
Recruiting
Hamburg, Germany, 22399
Recruiting
Hannover, Germany, 98109
Recruiting
Heidelberg, Germany
Recruiting
Homburg, Germany, 66421
Recruiting
Mannheim, Germany
Recruiting
Munster, Germany, 48149
Recruiting
Ulm, Germany
Recruiting
Weiden, Germany, 92637
Israel
Recruiting
Beer-Sheva, Israel
Recruiting
Haifa, Israel
Recruiting
Petah Tiqva, Israel
Recruiting
Ramat Gan, Israel
Recruiting
Zerifin, Israel
Italy
Recruiting
Arezzo, Italy
Recruiting
Cremona, Italy
Recruiting
Meldola, Italy
Recruiting
Rimini, Italy
Recruiting
Roma, Italy
Japan
Recruiting
Chiba, Japan
Recruiting
Fukuoka, Japan, 812-0033
Recruiting
Fukuoka, Japan, 812-8582
Recruiting
Hokkaido, Japan, 060-8543
Recruiting
Kanagawa, Japan
Recruiting
Kyoto, Japan, 6068507
Recruiting
Kyoto, Japan
Recruiting
Nagasaki, Japan, 8528501
Recruiting
Niigata, Japan
Recruiting
Osaka, Japan, 5458586
Recruiting
Osaka, Japan, 5378511
Recruiting
Osaka, Japan
Recruiting
Osaka, Japan, 565-0871
Recruiting
Shizuoka, Japan, 4313192
Recruiting
Tokushima, Japan, 7708503
Recruiting
Tokyo, Japan
Recruiting
Tokyo, Japan, 1358550
Recruiting
Tokyo, Japan, 181-8619
Recruiting
Tokyo, Japan, 113-8603
Recruiting
Tokyo, Japan, 142-8666
Recruiting
Tokyo, Japan, 160-8582
Recruiting
Yamagata, Japan
Recruiting
Yamaguchi, Japan, 755-8505
Korea, Republic of
Recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Recruiting
Jeonnam, Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Seoul, Korea, Republic of, 138-736
Recruiting
Seoul, Korea, Republic of, 137-701
Recruiting
Seoul, Korea, Republic of, 135-720
Lithuania
Terminated
Klaipeda, Lithuania
Recruiting
Vilnius, Lithuania
Netherlands
Recruiting
Amsterdam, Netherlands
Recruiting
Eindhoven, Netherlands, 5623 EJ
Recruiting
Groningen, Netherlands
Poland
Recruiting
Myslowice, Poland
Recruiting
Poznan, Poland
Recruiting
Wroclaw, Poland
Russian Federation
Recruiting
Moscow, Russian Federation
Recruiting
St. Petersburg, Russian Federation
Recruiting
St. Petersburg, Russian Federation, 197022
Singapore
Recruiting
Singapore, Singapore
Recruiting
Singapore, Singapore, 119074
Slovakia
Recruiting
Banska Bystrica, Slovakia
Recruiting
Bratislava, Slovakia
Recruiting
Martin, Slovakia
Recruiting
Nitra, Slovakia
Recruiting
Presov, Slovakia
Spain
Recruiting
Barcelona, Cataluna, Spain
Recruiting
Sabadell, Cataluna, Spain
Recruiting
Pamplona, Navarra, Spain
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Badalona, Spain
Recruiting
Barcelona, Spain
Recruiting
La Coruna, Spain
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Madrid, Spain
Recruiting
Manresa, Spain
Recruiting
Palma de Mallorca, Spain
Sweden
Recruiting
Goteborg, Sweden
Recruiting
Malmo, Sweden
Recruiting
Orebro, Sweden
Recruiting
Stockholm, Sweden
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Umea, Sweden
United Kingdom
Recruiting
Brighton, United Kingdom
Recruiting
Bristol, United Kingdom
Recruiting
Cardiff, United Kingdom
Recruiting
Edinburgh, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Merseyside, United Kingdom
Recruiting
Newcastle upon Tyne, United Kingdom
Recruiting
Northwood, United Kingdom
Recruiting
Oxford, United Kingdom
Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

Additional Information:
Trial Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hank Mansbach, MD, Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01212991     History of Changes
Other Study ID Numbers: MDV3100-03
Study First Received: September 29, 2010
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Progressive Metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 28, 2012



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