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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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ClinicalTrials.gov Identifier: NCT01547299
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : April 10, 2015
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Enzalutamide
Drug: Leuprolide
Drug: Dutasteride

  Participant Flow

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 Participants were administered 160 milligram (mg) of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
Enzalutamide Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.

Participant Flow:   Overall Study
    Enzalutamide + Leuprolide + Dutasteride   Enzalutamide
STARTED   25   27 
COMPLETED   23   25 
NOT COMPLETED   2   2 
Withdrawal by Subject                2                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Enzalutamide + Leuprolide + Dutasteride Participants were administered 160 mg of Enzalutamide orally once daily, 22.5 mg of Leuprolide every 3 months through intramuscular injection and 0.5 mg of Dutasteride orally once daily for up to 180 days.
Enzalutamide Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Total Total of all reporting groups

Baseline Measures
   Enzalutamide + Leuprolide + Dutasteride   Enzalutamide   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   27   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (6.95)   61.4  (7.65)   61.1  (7.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      25 100.0%      27 100.0%      52 100.0% 


  Outcome Measures

1.  Primary:   Pathologic Complete Response Rate   [ Time Frame: Day 180 ]

2.  Secondary:   Percentage of Participants With Positive Surgical Margins   [ Time Frame: Day 180 ]

3.  Secondary:   Percentage of Participants With Extracapsular Extension: Local Review   [ Time Frame: Day 180 ]

4.  Secondary:   Percentage of Participants With Extracapsular Extension: Central Review   [ Time Frame: Day 180 ]

5.  Secondary:   Percentage of Participants With Positive Seminal Vesicles   [ Time Frame: Day 180 ]

6.  Secondary:   Percentage of Participants With Positive Lymph Nodes   [ Time Frame: Day 180 ]

7.  Secondary:   Prostate-Specific Antigen (PSA) Nadir   [ Time Frame: Day 195 ]

8.  Secondary:   Time to Prostate-Specific Antigen (PSA) Nadir   [ Time Frame: Day 195 ]

9.  Secondary:   Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)   [ Time Frame: Day 195 ]

10.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score   [ Time Frame: Day 180 ]

11.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score   [ Time Frame: Day 180 ]

12.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score   [ Time Frame: Day 180 ]

13.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score   [ Time Frame: Day 180 ]

14.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score   [ Time Frame: Day 180 ]

15.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score   [ Time Frame: Day 180 ]

16.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score   [ Time Frame: Day 180 ]

17.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score   [ Time Frame: Day 180 ]

18.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score   [ Time Frame: Day 180 ]

19.  Secondary:   Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary   [ Time Frame: Day 180 ]

20.  Secondary:   Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)   [ Time Frame: Day 180 ]

21.  Secondary:   Pharmacodynamic Effects: Tissue Testosterone   [ Time Frame: Day 180 ]

22.  Secondary:   Pharmacodynamic Effects: Assessment of Apoptosis   [ Time Frame: Day 180 ]

23.  Secondary:   Pharmacodynamic Effects: Assessment of Mitotic Index   [ Time Frame: Day 180 ]

24.  Secondary:   Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining   [ Time Frame: Day 180 ]

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

26.  Secondary:   Serum Dihydrotestosterone (DHT): Day 180   [ Time Frame: Day 180 ]

27.  Secondary:   Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180   [ Time Frame: Day 180 ]

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

29.  Secondary:   Serum Testosterone: Day 180   [ Time Frame: Day 180 ]

30.  Secondary:   Change From Baseline in Serum Testosterone at Day 180   [ Time Frame: Day 180 ]

31.  Secondary:   Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation   [ Time Frame: From baseline up to 210 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01547299     History of Changes
Other Study ID Numbers: MDV3100-07
C3431019 ( Other Identifier: Alias Study Number )
First Submitted: February 27, 2012
First Posted: March 7, 2012
Results First Submitted: March 30, 2015
Results First Posted: April 10, 2015
Last Update Posted: December 20, 2017