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

NCT01547299

Last updated date
Study Location
Boston, Massachusetts, 02215, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Official Title  ICMJE A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer
Brief Summary The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    Other Name: MDV3100
  • Drug: Leuprolide
  • Drug: Dutasteride
Study Arms  ICMJE
  • 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2012)
50
Actual Study Completion Date  ICMJE November 30, 2013
Actual Primary Completion Date November 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547299
Other Study ID Numbers  ICMJE MDV3100-07
C3431019 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP