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Trial record 96 of 117 for:    DUTASTERIDE

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 : October 23, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer 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
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description 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. Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Period Title: Overall Study
Started 25 27
Completed 23 25
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2             2
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide Total
Hide Arm/Group Description 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. Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days. Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
60.8  (6.95) 61.4  (7.65) 61.1  (7.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
27
 100.0%
52
 100.0%
1.Primary Outcome
Title Pathologic Complete Response Rate
Hide Description Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Local pathologist
8.7
(1.1 to 28.0)
0.0
(0.0 to 13.7)
Central pathologist
4.3
(0.1 to 21.9)
0.0
(0.0 to 13.7)
2.Secondary Outcome
Title Percentage of Participants With Positive Surgical Margins
Hide Description To determine the percentage of participants with positive surgical margins at prostatectomy as assessed by the local and central pathologist. Surgical margin, also known as tumor free margin referred to the visible normal tissue or skin margin that was removed with the surgical excision of a tumor, growth, or malignancy. The margin was described as positive when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Local pathologist
4.3
(0.1 to 21.9)
12.0
(2.5 to 31.2)
Central pathologist
21.7
(7.5 to 43.7)
16.0
(4.5 to 36.1)
3.Secondary Outcome
Title Percentage of Participants With Extracapsular Extension: Local Review
Hide Description To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the local pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.1
(10.2 to 48.4)
36.0
(18.0 to 57.5)
4.Secondary Outcome
Title Percentage of Participants With Extracapsular Extension: Central Review
Hide Description To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the central pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment with a prostatectomy sample evaluated by the central pathologist. One participant in the Enzalutamide treatment arm was excluded from the analysis because the result reported by the central lab was indeterminate. Here, "N" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.5
(34.5 to 76.8)
70.8
(48.9 to 87.4)
5.Secondary Outcome
Title Percentage of Participants With Positive Seminal Vesicles
Hide Description To determine the percentage of participants with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist. Seminal vesicles or seminal glands, were defined as a pair of simple tubular glands located within the pelvis. They secrete fluid that partly composes the semen. Seminal vesicles with cancer cells in them were called positive seminal vesicles.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Local pathologist
30.4
(13.2 to 52.9)
36.0
(18.0 to 57.5)
Central pathologist
30.4
(13.2 to 52.9)
36.0
(18.0 to 57.5)
6.Secondary Outcome
Title Percentage of Participants With Positive Lymph Nodes
Hide Description To determine the percentage of participants with positive lymph nodes at prostatectomy as assessed by the local and central pathologist. Lymph nodes were small clumps of immune cells that act as filters for the lymphatic system. Lymph nodes with cancer cells in them were called positive lymph nodes.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Local pathologist
26.1
(10.2 to 48.4)
4.0
(0.1 to 20.4)
Central pathologist
26.1
(10.2 to 48.4)
4.0
(0.1 to 20.4)
7.Secondary Outcome
Title Prostate-Specific Antigen (PSA) Nadir
Hide Description To determine the effects on PSA as measured by the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant’s lowest observed post baseline PSA value.
Time Frame Day 195
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 24 25
Median (Full Range)
Unit of Measure: microgram per liter (mcg/L)
0.04
(0.01 to 0.53)
0.51
(0.02 to 8.80)
8.Secondary Outcome
Title Time to Prostate-Specific Antigen (PSA) Nadir
Hide Description To determine the effects on PSA as measured by the time to the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant’s lowest observed post baseline PSA value.
Time Frame Day 195
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 27
Median (Full Range)
Unit of Measure: days
5.09
(2.79 to 6.44)
6.01
(2.89 to 6.64)
9.Secondary Outcome
Title Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)
Hide Description To determine the effects on PSA as measured by the percentage of participants with PSA less than (<) 0.2 nanogram per milliliter (ng/mL), and a 50 percent (%) and 90% decrease in PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland.
Time Frame Day 195
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PSA < 0.2 ng/mL
92.0
(74.0 to 99.0)
29.6
(13.8 to 50.2)
50% decrease in PSA
100.0
(86.3 to 100.0)
100.0
(87.2 to 100.0)
90% decrease in PSA
100.0
(86.3 to 100.0)
63.0
(42.4 to 80.6)
10.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score
Hide Description EPIC sexual domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. Sexual domain summary score was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function and satisfaction. Best change from baseline category in EPIC sexual domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
Worsened 11 10
Stable 4 6
Improved 1 0
11.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score
Hide Description EPIC sexual function subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual function subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function. Best change from baseline category in EPIC sexual function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 15 17
Measure Type: Number
Unit of Measure: participants
Worsened 11 12
Stable 4 5
Improved 0 0
12.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score
Hide Description EPIC sexual bother subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual bother subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing less sexual bother and difficulty. Best change from baseline category in EPIC sexual bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
Worsened 7 5
Stable 9 7
Improved 0 4
13.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score
Hide Description EPIC Hormonal Domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 10 10
Stable 3 7
Improved 3 1
14.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score
Hide Description EPIC hormonal function subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal function subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 11 11
Stable 2 7
Improved 3 0
15.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score
Hide Description EPIC hormonal bother subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal bother subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing less hormonal bothering. Best change from baseline category in EPIC hormonal bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 9 6
Stable 5 11
Improved 2 1
16.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score
Hide Description The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The general health domain score contained 1 item scored on a scale of 1 to 5 where 1=excellent to 5=poor health, where higher score indicated worse health status. Best change from baseline category in general health domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 5 5
Stable 9 6
Improved 2 7
17.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score
Hide Description The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The physical functioning domain score contained 2 items each scored on a scale of 1 to 5 where 1=excellent physical functioning to 5=poor physical functioning. Physical functioning domain total score ranged from 1 to 10, where higher scores indicated poor physical functioning. Best change from baseline category in physical functioning domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 3 2
Stable 12 15
Improved 1 1
18.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score
Hide Description The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5, where higher scores indicated worse mental status. The total score ranged from 1 to 10, where higher scores indicated worse mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 18
Measure Type: Number
Unit of Measure: participants
Worsened 3 1
Stable 9 10
Improved 4 7
19.Secondary Outcome
Title Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary
Hide Description The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5 where for 1 item 1=all of the time person felt calm and peaceful to 5=none of the time person felt calm and peaceful. The score ranged from 1 to 5, where higher scores meant worse mental status. For other item 1=all of the time person felt downhearted and blue to 5=none of the time person felt downhearted and blue. The score ranged from 1 to 5, where higher scores meant better mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: participants
Worsened 4 1
Stable 8 11
Improved 4 5
20.Secondary Outcome
Title Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)
Hide Description To determine pharmacodynamic effects as measured by the amount of tissue DHT in prostatectomy specimens following radical prostatectomy.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: picogram per milligram
0.04  (0.01) 3.34  (1.57)
21.Secondary Outcome
Title Pharmacodynamic Effects: Tissue Testosterone
Hide Description To determine pharmacodynamic effects as measured by the amount of tissue testosterone in prostatectomy specimens following radical prostatectomy.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: picogram per milligram
0.18  (0.13) 0.90  (0.86)
22.Secondary Outcome
Title Pharmacodynamic Effects: Assessment of Apoptosis
Hide Description To determine the effects of triplet therapy and enzalutamide alone on apoptosis in prostatectomy specimens. Apoptosis was a process of biochemical events that lead to characteristic cell changes and death.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected as assessment of apoptosis was not performed due to limited amounts of tissue samples available.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Pharmacodynamic Effects: Assessment of Mitotic Index
Hide Description Assessment was performed to determine the effects of triplet therapy and enzalutamide alone on mitotic index. Mitotic index was defined as the ratio between the numbers of cells in a population undergoing mitosis to the number of cells in a population not undergoing mitosis in prostatectomy specimens.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: ratio
0.9  (1.51) 2.6  (2.81)
24.Secondary Outcome
Title Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining
Hide Description To determine the effects of triplet therapy and enzalutamide alone on androgen receptor signaling in prostatectomy specimens. Androgen receptor (AR) was a type of nuclear receptor that was activated by binding either of the androgenic hormones, testosterone, or dihydrotestosterone in the cytoplasm and then translocating into the nucleus. Androgen receptor (AR) signaling represented the major therapeutic target for treating metastatic prostate cancer. Assessment of androgen receptor signaling was measured by intensity of androgen receptor IHC staining and were graded as 0 (absent), 1 (weak), 2 (moderate) and 3 (strong). Percentage of participants within each grade are reported below.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 27
Measure Type: Number
Unit of Measure: percentage of participants
0 0.0 0.0
1 5.6 0.0
2 27.8 5.3
3 66.7 94.7
25.Secondary Outcome
Title Serum Dihydrotestosterone (DHT): Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum DHT result. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 27
Median (Full Range)
Unit of Measure: ng/mL
0.34
(0.08 to 0.58)
0.29
(0.16 to 0.85)
26.Secondary Outcome
Title Serum Dihydrotestosterone (DHT): Day 180
Hide Description [Not Specified]
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with 180 days post baseline serum DHT result. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 25
Median (Full Range)
Unit of Measure: ng/mL
0.01
(0.01 to 0.04)
0.51
(0.10 to 1.10)
27.Secondary Outcome
Title Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180
Hide Description To determine serum hormone effects as measured by change in DHT values from baseline to the completion of therapy.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a serum DHT result at baseline and 180 days post baseline. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Median (Full Range)
Unit of Measure: ng/mL
-0.33
(-0.57 to -0.07)
0.25
(-0.16 to 0.71)
28.Secondary Outcome
Title Serum Testosterone: Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum testosterone result. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 27
Median (Full Range)
Unit of Measure: ng/mL
4.10
(0.77 to 6.77)
3.69
(2.00 to 7.91)
29.Secondary Outcome
Title Serum Testosterone: Day 180
Hide Description [Not Specified]
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a 180 days post baseline serum testosterone result. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 25
Median (Full Range)
Unit of Measure: ng/mL
0.12
(0.05 to 0.29)
9.76
(1.99 to 16.63)
30.Secondary Outcome
Title Change From Baseline in Serum Testosterone at Day 180
Hide Description To determine serum hormone effects as measured by change in testosterone at baseline and at completion of therapy.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to study treatment (intent-to-treat population) with a serum testosterone result at baseline and 180 days post baseline. Here, "N" signifies number of participants evaluable for this specified outcome measure.
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 23 25
Median (Full Range)
Unit of Measure: ng/mL
-4.00
(-6.67 to -0.67)
5.74
(-1.94 to 12.29)
31.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame From baseline up to 210 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 partial dose of enzalutamide (safety population).
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description:
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.
Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
Overall Number of Participants Analyzed 25 27
Measure Type: Number
Unit of Measure: participants
Permanent Discontinuation of Enzalutamide 0 0
Temporary Interruption of Enzalutamide 3 0
Dose Reduction of Enzalutamide 0 0
Study Drug Discontinuation 0 0
Time Frame From baseline to 30 days after the last dose of study drug, up to 210 days.
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all participants who received at least one partial dose of study drug.
 
Arm/Group Title Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Hide Arm/Group Description 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. Participants were administered 160 mg of Enzalutamide orally once daily for up to 180 days.
All-Cause Mortality
Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   3/25 (12.00%)   2/27 (7.41%) 
Infections and infestations     
Pelvic abscess  1  0/25 (0.00%)  1/27 (3.70%) 
Clostridial infection  1  1/25 (4.00%)  0/27 (0.00%) 
Injury, poisoning and procedural complications     
Postoperative ileus  1  1/25 (4.00%)  0/27 (0.00%) 
Vascular disorders     
Lymphocele  1  1/25 (4.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enzalutamide + Leuprolide + Dutasteride Enzalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   25/25 (100.00%)   27/27 (100.00%) 
Gastrointestinal disorders     
Diarrhoea  1  6/25 (24.00%)  5/27 (18.52%) 
Constipation  1  4/25 (16.00%)  2/27 (7.41%) 
Nausea  1  4/25 (16.00%)  2/27 (7.41%) 
Abdominal pain  1  2/25 (8.00%)  0/27 (0.00%) 
Haematochezia  1  0/25 (0.00%)  2/27 (7.41%) 
Rectal haemorrhage  1  0/25 (0.00%)  2/27 (7.41%) 
General disorders     
Fatigue  1  15/25 (60.00%)  19/27 (70.37%) 
Oedema peripheral  1  2/25 (8.00%)  2/27 (7.41%) 
Pyrexia  1  2/25 (8.00%)  2/27 (7.41%) 
Chills  1  2/25 (8.00%)  1/27 (3.70%) 
Infections and infestations     
Nasopharyngitis  1  4/25 (16.00%)  2/27 (7.41%) 
Sinusitis  1  3/25 (12.00%)  1/27 (3.70%) 
Urinary tract infection  1  3/25 (12.00%)  1/27 (3.70%) 
Diverticulitis  1  2/25 (8.00%)  1/27 (3.70%) 
Upper respiratory tract infection  1  2/25 (8.00%)  1/27 (3.70%) 
Injury, poisoning and procedural complications     
Incision site pain  1  4/25 (16.00%)  5/27 (18.52%) 
Investigations     
Oestradiol increased  1  0/25 (0.00%)  3/27 (11.11%) 
Weight decreased  1  1/25 (4.00%)  2/27 (7.41%) 
Alanine aminotransferase increased  1  2/25 (8.00%)  0/27 (0.00%) 
Aspartate aminotransferase increased  1  2/25 (8.00%)  0/27 (0.00%) 
Blood creatinine increased  1  0/25 (0.00%)  2/27 (7.41%) 
Weight increased  1  0/25 (0.00%)  2/27 (7.41%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/25 (8.00%)  3/27 (11.11%) 
Hypokalaemia  1  1/25 (4.00%)  3/27 (11.11%) 
Hyperglycaemia  1  1/25 (4.00%)  2/27 (7.41%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  4/25 (16.00%)  0/27 (0.00%) 
Musculoskeletal pain  1  2/25 (8.00%)  1/27 (3.70%) 
Arthralgia  1  2/25 (8.00%)  0/27 (0.00%) 
Nervous system disorders     
Headache  1  3/25 (12.00%)  3/27 (11.11%) 
Memory impairment  1  3/25 (12.00%)  3/27 (11.11%) 
Restless leg syndrome  1  3/25 (12.00%)  3/27 (11.11%) 
Amnesia  1  0/25 (0.00%)  3/27 (11.11%) 
Mental impairment  1  1/25 (4.00%)  2/27 (7.41%) 
Psychiatric disorders     
Insomnia  1  9/25 (36.00%)  6/27 (22.22%) 
Libido decreased  1  8/25 (32.00%)  4/27 (14.81%) 
Anxiety  1  4/25 (16.00%)  1/27 (3.70%) 
Depression  1  2/25 (8.00%)  1/27 (3.70%) 
Renal and urinary disorders     
Pollakiuria  1  6/25 (24.00%)  4/27 (14.81%) 
Urinary incontinence  1  2/25 (8.00%)  5/27 (18.52%) 
Incontinence  1  3/25 (12.00%)  3/27 (11.11%) 
Nocturia  1  3/25 (12.00%)  1/27 (3.70%) 
Dysuria  1  0/25 (0.00%)  2/27 (7.41%) 
Micturition urgency  1  2/25 (8.00%)  0/27 (0.00%) 
Urinary retention  1  0/25 (0.00%)  2/27 (7.41%) 
Reproductive system and breast disorders     
Gynaecomastia  1  3/25 (12.00%)  17/27 (62.96%) 
Breast tenderness  1  2/25 (8.00%)  9/27 (33.33%) 
Erectile dysfunction  1  2/25 (8.00%)  6/27 (22.22%) 
Breast pain  1  0/25 (0.00%)  7/27 (25.93%) 
Nipple pain  1  1/25 (4.00%)  3/27 (11.11%) 
Penile pain  1  2/25 (8.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/25 (4.00%)  2/27 (7.41%) 
Nasal congestion  1  0/25 (0.00%)  2/27 (7.41%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  0/25 (0.00%)  3/27 (11.11%) 
Vascular disorders     
Hot flush  1  24/25 (96.00%)  7/27 (25.93%) 
Hypertension  1  3/25 (12.00%)  3/27 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.0
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.
PI agrees not to independently publish the results before the publication of the multi-center PI paper. Sponsor shall review and comment 30 days prior to submission or disclosure. If publication or disclosure contains Sponsor Confidential Information, other than study data, PI agrees to remove Confidential Information from publication or disclosure. Sponsor may request that PI delay such publication for an additional 60 days to protect the patentability of any invention described.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Novotny, MD, Sr. Director, Clinical Development
Organization: Medivation, Inc.
Phone: 415- 983-3066
EMail: william.novotny@medivation.com
Layout table for additonal information
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: October 23, 2018