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Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

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NCT01547299

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Boston, Massachusetts, 02215 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Willing to provide informed consent

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Stage T4 prostate cancer by clinical or radiologic evaluation

- 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

NCT01547299
Pfizer
Completed
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

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[email protected]

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Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer
The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Enzalutamide
    Other Name: MDV3100
  • Drug: Leuprolide
  • Drug: Dutasteride
  • Experimental: Enzalutamide alone
    Enzalutamide 160 mg, orally, once daily
    Intervention: Drug: Enzalutamide
  • Experimental: 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
    Interventions:
    • Drug: Enzalutamide
    • Drug: Leuprolide
    • Drug: Dutasteride
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 30, 2013
November 30, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing to provide informed consent
  • 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:

  • Stage T4 prostate cancer by clinical or radiologic evaluation
  • 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
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01547299
MDV3100-07
C3431019 ( Other Identifier: Alias Study Number )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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