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: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 29, 2010
Last Updated Date	January 29, 2013
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 30, 2010)	Overall Survival Progression-free Survival
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01212991 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 30, 2010)	Time to first skeletal-related event Time to initiation of cytotoxic chemotherapy
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: MDV3100 Drug: Placebo
Study Arm (s)	Experimental: MDV3100 Intervention: Drug: MDV3100 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	1680
Completion Date	Not Provided
Estimated Primary Completion Date	September 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01212991
Other Study ID Numbers ^ICMJE	MDV3100-03
Has Data Monitoring Committee	Yes
Responsible Party	Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Astellas Pharma Inc
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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