A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01212991
First received: September 29, 2010
Last updated: May 27, 2014
Last verified: May 2014
  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 3

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:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Designated as safety issue: No ]
  • Progression-free Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first skeletal-related event [ Designated as safety issue: No ]
  • Time to initiation of cytotoxic chemotherapy [ Designated as safety issue: No ]
  • Prostate-specific antigen (PSA) progression [ Designated as safety issue: No ]
  • Prostate-specific antigen (PSA) response > 50% [ Designated as safety issue: No ]
  • Best overall soft tissue response [ Designated as safety issue: No ]

Estimated Enrollment: 1680
Study Start Date: September 2010
Primary Completion Date: September 2013 (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

Randomized, Double Blind Treatment Period:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Beverly Hills, California, United States, 90211
Los Angeles, California, United States, 90024
Los Angeles, California, United States, 90033
Sacramento, California, United States, 95817
San Diego, California, United States, 92123
Stanford, California, United States, 94305
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Boca Raton, Florida, United States, 33486
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Kentucky
Louisville, Kentucky, United States, 40245
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 2115
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas, Nevada, United States, 89135
United States, New York
New York, New York, United States, 11201
New York, New York, United States, 10029
United States, North Carolina
Cary, North Carolina, United States, 27518
Charlotte, North Carolina, United States, 28211
Durham, North Carolina, United States, 27710
Raleigh, North Carolina, United States, 27607
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Dallas, Texas, United States, 75235
United States, Virginia
Newport News, Virginia, United States, 23502
Norfolk, Virginia, United States, 23502
Virginia Beach, Virginia, United States, 23456
United States, Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Concord, New South Wales, Australia
Hornsby, New South Wales, Australia, 2077
Kogarah, New South Wales, Australia
Lismore, New South Wales, Australia
Liverpool, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
St. Leonards, New South Wales, Australia, 2065
Tamworth, New South Wales, Australia, 2340
Wahroonga, New South Wales, Australia
Waratah, New South Wales, Australia
Westmead, New South Wales, Australia
Australia, Queensland
Herston, Queensland, Australia
South Brisbane, Queensland, Australia
Australia, South Australia
Kurralta Park, South Australia, Australia
Australia, Victoria
Bendigo, Victoria, Australia
Box Hill, Victoria, Australia
East Bentleigh, Victoria, Australia, 3144
East Melbourne, Victoria, Australia
Footscray, Victoria, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Malvern, Victoria, Australia, 3144
Parkville, Victoria, Australia
Australia
New South Wales, Australia
Austria
Wien, Vienna, Austria
Graz, Austria
Linz, Austria
Salzburg, Austria, 5020
Salzburg, Austria
Wien, Austria
Belgium
Bruxelles, Belgium
Gent, Belgium
Hasselt, Belgium
Kortrijk, Belgium
Leuven, Belgium
Liege, Belgium
Roeselare, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 1M9
Victoria, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M
Quebec City, Quebec, Canada, G1R 3S3
Sherbrooke, Quebec, Canada
Denmark
Aalborg, Denmark
Aarhus, Denmark
Copenhagen, Denmark
Frederiksberg, Denmark
Herlev, Denmark
Roskilde, Denmark
Finland
Helsinki, Finland
Oulu, Finland
Tampere, Finland
France
Angers, France
Avignon, France
Bordeaux, France
Bordeaux, France, 33075
La Roche sur Yon, France
Le Mans, France
Lyon, France
Paris, France
Paris, France, 75475
Paris, France, 75005
Paris, France, 75230
Paris Cedex 15, France
Rennes, France
Saint Herblain, France
Saint Priest en Jarez, France
Strasbourg, France
Toulouse, France
Villejuif, France
Germany
Berlin, Germany, 12203
Braunschweig, Germany
Dresden, Germany
Hamburg, Germany, 20246
Hamburg, Germany, 22399
Hannover, Germany, 98109
Heidelberg, Germany
Homburg, Germany, 66421
Mannheim, Germany
Munster, Germany, 48149
Tubingen, Germany, 72076
Ulm, Germany
Weiden, Germany, 92637
Israel
Beer-Sheva, Israel
Haifa, Israel
Petah Tiqva, Israel
Ramat Gan, Israel
Zerifin, Israel
Italy
Arezzo, Italy
Cremona, Italy
Meldola, Italy
Orbassano, Italy, 10043
Ravenna, Italy, 5-48121
Rimini, Italy
Roma, Italy
Japan
Chiba, Japan
Fukuoka, Japan, 812-0033
Fukuoka, Japan, 812-8582
Hokkaido, Japan, 060-8543
Kanagawa, Japan
Kyoto, Japan, 6068507
Kyoto, Japan
Miyagi, Japan, 980-8574
Nagasaki, Japan, 8528501
Niigata, Japan
Osaka, Japan, 5458586
Osaka, Japan, 5378511
Osaka, Japan
Osaka, Japan, 565-0871
Shizuoka, Japan, 4313192
Tokushima, Japan, 7708503
Tokyo, Japan
Tokyo, Japan, 1358550
Tokyo, Japan, 181-8619
Tokyo, Japan, 113-8603
Tokyo, Japan, 160-8582
Tokyo, Japan, 142-8666
Yamagata, Japan
Yamaguchi, Japan, 755-8505
Korea, Republic of
Gyenoggi-do, Korea, Republic of, 410-769
Gyeonggi-do, Korea, Republic of, 410-769
Jeonnam, Korea, Republic of
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 135-720
Lithuania
Klaipeda, Lithuania
Vilnius, Lithuania
Netherlands
Amsterdam, Netherlands
Eindhoven, Netherlands, 5623 EJ
Groningen, Netherlands
RB Groningen, Netherlands, 9713 GZ
Poland
Gdansk, Poland, 80-211
Lodz, Poland, 93-509
Myslowice, Poland
Poznan, Poland
Wroclaw, Poland
Wroclaw, Poland, 54-144
Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
St. Petersburg, Russian Federation, 197022
Singapore
Singapore, Singapore
Singapore, Singapore, 119074
Slovakia
Banska Bystrica, Slovakia
Bratislava, Slovakia
Martin, Slovakia
Nitra, Slovakia
Presov, Slovakia
Spain
Barcelona, Cataluna, Spain
Sabadell, Cataluna, Spain
Pamplona, Navarra, Spain
Badalona, Spain
Barcelona, Spain
Barcelona, Spain, 08036
La Coruna, Spain
Madrid, Spain, 28034
Madrid, Spain
Manresa, Spain
Palma de Mallorca, Spain
Sweden
Goteborg, Sweden
Malmo, Sweden
Orebro, Sweden
Stockholm, Sweden
Umea, Sweden
United Kingdom
Brighton, United Kingdom
Bristol, United Kingdom
Cardiff, United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
London, United Kingdom, W12 0NN
London, United Kingdom, SE1 9RT
Merseyside, United Kingdom
Newcastle upon Tyne, United Kingdom
Northwood, United Kingdom
Oxford, United Kingdom
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided by Medivation, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01212991     History of Changes
Other Study ID Numbers: MDV3100-03
Study First Received: September 29, 2010
Last Updated: May 27, 2014
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 August 27, 2014