Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
NCT ID: NCT01547299
Last Updated: 2018-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2012-03-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enzalutamide alone
Enzalutamide 160 mg, orally, once daily
Enzalutamide
Enzalutamide & Leuprolide & Dutasteride
Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
Enzalutamide
Leuprolide
Dutasteride
Interventions
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Enzalutamide
Leuprolide
Dutasteride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Histologically confirmed adenocarcinoma of the prostate
* Must be a candidate for radical prostatectomy and considered surgically resectable
Exclusion Criteria
* Treatment with an investigational agent within 4 weeks prior to randomization
* Received therapy for other neoplastic disorders within 5 years
* Hypogonadism or severe androgen deficiency
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Boston, Massachusetts, United States
Seattle, Washington, United States
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Countries
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Other Identifiers
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C3431019
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-07
Identifier Type: -
Identifier Source: org_study_id
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