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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01547299
First received: February 27, 2012
Last updated: April 21, 2015
Last verified: April 2015
Results First Received: March 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Leuprolide
Drug: Dutasteride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 Alone Enzalutamide 160 mg, orally, once daily

Participant Flow:   Overall Study
    Enzalutamide & Leuprolide & Dutasteride     Enzalutamide Alone  
STARTED     25     27  
COMPLETED     23     25  
NOT COMPLETED     2     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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 Alone Enzalutamide 160 mg, orally, once daily
Total Total of all reporting groups

Baseline Measures
    Enzalutamide & Leuprolide & Dutasteride     Enzalutamide Alone     Total  
Number of Participants  
[units: participants]
  25     27     52  
Age  
[units: years]
Mean (Standard Deviation)
  60.8  (6.95)     61.4  (7.65)     61.1  (7.26)  
Age, Customized  
[units: patients]
     
< 65     17     15     32  
65 to 74     8     11     19  
>= 75     0     1     1  
Gender  
[units: patients]
     
Female     0     0     0  
Male     25     27     52  



  Outcome Measures
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1.  Primary:   Pathologic Complete Response Rate   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Patients With Positive Surgical Margins   [ Time Frame: 6 months ]

3.  Secondary:   Percentage of Patients With Extracapsular Extension: Local Review   [ Time Frame: 6 months ]

4.  Secondary:   Percentage of Patients With Extracapsular Extension: Central Review   [ Time Frame: 6 months ]

5.  Secondary:   Percentage of Patients With Positive Seminal Vesicles   [ Time Frame: 6 months ]

6.  Secondary:   Percentage of Patients With Positive Lymph Nodes   [ Time Frame: 6 months ]

7.  Secondary:   Prostate-Specific Antigen (PSA) Nadir   [ Time Frame: 6 months ]

8.  Secondary:   Time to Prostate-Specific Antigen (PSA) Nadir   [ Time Frame: 6 months ]

9.  Secondary:   Percentage of Patients With Reduction in Prostate-Specific Antigen (PSA)   [ Time Frame: 6 months ]

10.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score   [ Time Frame: 6 months ]

11.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score   [ Time Frame: 6 months ]

12.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score   [ Time Frame: 6 months ]

13.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score   [ Time Frame: 6 months ]

14.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score   [ Time Frame: 6 months ]

15.  Secondary:   Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score   [ Time Frame: 6 months ]

16.  Secondary:   Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 General Health Domain Score   [ Time Frame: 6 months ]

17.  Secondary:   Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Physical Functioning Domain Score   [ Time Frame: 6 months ]

18.  Secondary:   Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Role-Emotional Domain Score   [ Time Frame: 6 months ]

19.  Secondary:   Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Mental Component Summary   [ Time Frame: 6 months ]

20.  Secondary:   Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)   [ Time Frame: 6 months ]

21.  Secondary:   Pharmacodynamic Effects: Tissue Testosterone   [ Time Frame: 6 months ]

22.  Secondary:   Serum Dihydrotestosterone (DHT): Baseline   [ Time Frame: Baseline ]

23.  Secondary:   Serum Dihydrotestosterone (DHT): 6 Months Postbaseline   [ Time Frame: 6 months ]

24.  Secondary:   Change From Baseline in Serum Dihydrotestosterone (DHT)   [ Time Frame: Baseline, 6 months ]

25.  Secondary:   Serum Testosterone: Baseline   [ Time Frame: Baseline ]

26.  Secondary:   Serum Testosterone: 6 Months Postbaseline   [ Time Frame: 6 months ]

27.  Secondary:   Change From Baseline in Serum Testosterone   [ Time Frame: Baseline, 6 months ]

28.  Secondary:   Number of Patients With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation   [ Time Frame: 6 months ]

29.  Secondary:   Pharmacodynamic Effects: Assessment of Apoptosis   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

30.  Secondary:   Pharmacodynamic Effects: Assessment of Mitotic Index   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2015   Safety Issue:   No

31.  Secondary:   Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: William Novotny, MD, Sr. Director, Clinical Development
Organization: Medivation, Inc.
phone: 415- 983-3066
e-mail: william.novotny@medivation.com


No publications provided


Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01547299     History of Changes
Other Study ID Numbers: MDV3100-07
Study First Received: February 27, 2012
Results First Received: March 30, 2015
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration