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Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

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ClinicalTrials.gov Identifier: NCT00363311
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : June 14, 2011
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Neoplasms, Prostate
Interventions Drug: Dutasteride
Drug: Matching placebo
Enrollment 302
Recruitment Details  
Pre-assignment Details A completed participant is defined as one who completed the 36-month treatment phase of the study and the 4-month safety follow-up phase.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks Dutasteride 0.5 mg administered orally once daily for 156 weeks
Period Title: Overall Study
Started 155 147
Completed 79 102
Not Completed 76 45
Reason Not Completed
Adverse Event             6             4
Lost to Follow-up             3             0
Protocol Violation             1             2
Withdrawal by Subject             12             6
Physician Decision             1             1
Sponsor Terminated Study             2             2
Disease Progression             46             26
Non-Compliance             1             1
Participant Refused Biopsy             1             0
Prostate Volume/PSA Doubled             1             0
Participant Opted for Treatment             1             0
Participant Moved to Another Country             1             0
Participant Withdrew Waiting for Surgery             0             1
Withdrawn per Instructions of Monitor             0             1
Participant Moved to Louisiana             0             1
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily Total
Hide Arm/Group Description Matching placebo 0.5 mg administered orally once daily for 156 weeks Dutasteride 0.5 mg administered orally once daily for 156 weeks Total of all reporting groups
Overall Number of Baseline Participants 155 147 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 147 participants 302 participants
65.0  (7.56) 65.1  (7.13) 65.0  (7.34)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 147 participants 302 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
155
 100.0%
147
 100.0%
302
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 147 participants 302 participants
White 141 132 273
African American 12 8 20
Asian 1 4 5
American Indian or Alaskan Native 0 1 1
Native Hawaiian or Other Pacific Islander 1 1 2
White and American Indian/Alaskan Native 0 1 1
1.Primary Outcome
Title Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
Hide Description PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
Time Frame Year 1.5 and Overall (Years 0-3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Measure Type: Number
Unit of Measure: participants
Year 1.5, n=144, 142 50 32
Overall (Years 0-3), n= 155, 147 71 54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Statistical data are for Year 1.5
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.56
Confidence Interval 95%
0.36 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Statistical data are for Overall (Years 0-3)
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.61
Confidence Interval 95%
0.43 to 0.88
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Therapeutic Progression
Hide Description Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.
Time Frame Year 1.5 and Overall (Years 0-3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Measure Type: Number
Unit of Measure: participants
Year 1.5 11 5
Overall (Years 0-3) 20 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments Statistical data are for Year 1.5
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.46
Confidence Interval 95%
0.16 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments Statistical data are for Overall (Years 0-3)
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.48
Confidence Interval 95%
0.22 to 1.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Pathologic Progression
Hide Description Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.
Time Frame Year 1.5 and Overall (Years 0-3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 136 140
Measure Type: Number
Unit of Measure: participants
Year 1.5, n= 136, 139 39 27
Overall (Years 0-3) n=136, 140 51 43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Statistical data are for Year 1.5
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.59
Confidence Interval 95%
0.36 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments Statistical data are for Overall (Years 0-3)
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Estimate
Estimated Value 0.70
Confidence Interval 95%
0.46 to 1.05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
Hide Description All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.
Time Frame Baseline to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 136 140
Measure Type: Number
Unit of Measure: participants
Participants with a PCa diagnosis 111 111
Participants with no PCa diagnosis 25 29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
Time Frame Years 0-3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 136 140
Measure Type: Number
Unit of Measure: participants
Participants with a PCa diagnosis 105 90
Participants with no PCa diagnosis 31 50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Number of Cancer-positive Cores in a 12-core Biopsy
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: cores
Baseline, n=155, 147 1.6  (0.74) 1.6  (0.72)
Year 1.5, n=87, 99 2.8  (1.82) 2.2  (1.25)
Year 3, n=52, 54 2.0  (1.17) 2.0  (0.95)
Years 0-3 (Final biopsy), n=105, 90 3.0  (2.03) 2.5  (1.25)
7.Secondary Outcome
Title Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 105 90
Mean (Standard Deviation)
Unit of Measure: cores
Year 1.5, n= 87, 99 1.1  (1.63) 0.6  (1.36)
Year 3, n=52, 54 2.0  (1.17) 2.0  (0.95)
Years 0-3 (Final biopsy), n=105, 90 3.0  (2.03) 2.5  (1.25)
8.Secondary Outcome
Title Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: percentage of cores
Baseline, n= 155, 147 14.3  (7.30) 14.5  (6.95)
Year 1.5, n=87, 99 23.7  (15.76) 19.0  (10.66)
Year 3, n=52, 54 16.5  (9.71) 17.3  (8.44)
Years 0-3 (Final biopsy), n=105, 90 24.7  (15.66) 21.7  (10.76)
9.Secondary Outcome
Title Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 105 90
Mean (Standard Deviation)
Unit of Measure: percentage of cores
Year 1.5, n= 87, 99 8.4  (13.73) 3.7  (11.97)
Year 3, n=52, 54 4.1  (9.84) 1.5  (10.03)
Years 0-3 (Final biopsy), n=105, 90 10.0  (13.88) 6.0  (11.40)
10.Secondary Outcome
Title Cumulative Length of Cancer Tumor Core
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline, n= 155, 147 2.0  (1.86) 2.1  (2.04)
Year 1.5, n=87, 99 6.2  (5.99) 4.8  (6.34)
Year 3, n=52, 54 3.7  (3.82) 3.8  (3.51)
Years 0-3 (Final biopsy), n=105, 90 7.0  (7.02) 6.1  (6.19)
11.Secondary Outcome
Title Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
Hide Description All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.
Time Frame Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 105 90
Mean (Standard Deviation)
Unit of Measure: millimeters
Year 1.5, n= 87, 99 3.9  (5.71) 2.5  (6.59)
Year 3, n=52, 54 1.8  (3.94) 1.5  (3.58)
Years 0-3 (Final biopsy), n=105, 90 4.8  (6.70) 3.8  (6.27)
12.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
Hide Description The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
Time Frame Year 1.5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 81 100
Measure Type: Number
Unit of Measure: participants
Improvement 6 21
No change 51 58
Worsening 24 21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
Hide Description The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
Time Frame Years 0-3 (Final Biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 136 140
Measure Type: Number
Unit of Measure: participants
Improvement 31 50
No cancer, GS 0 31 50
No change 83 71
Worsening 22 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With the Indicated Total Gleason Score
Hide Description All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.
Time Frame Years 0-3 (Final Biopsy)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 136 140
Measure Type: Number
Unit of Measure: participants
Missing (No Cancer) 31 50
GS 5 0 0
GS 6 83 71
GS 7, 3 (primary grade) + 4 (secondary grade) 15 13
GS 7, 4 (primary grade) + 3 (secondary grade) 4 4
GS 8 3 2
GS 9-10 0 0
15.Secondary Outcome
Title Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
Hide Description All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 155 147
Measure Type: Number
Unit of Measure: biopsies
T1c 125 117
T2a 30 29
T2c 0 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
Hide Description All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."
Time Frame Months 0-18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 66 58
Measure Type: Number
Unit of Measure: biopsies
No Worsening (same/lower stage) 53 53
Worsening (higher stage) 13 5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matching Placebo 0.5 mg Once Daily, Dutasteride 0.5 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Prostate Volume (PV) LOCF
Hide Description

Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

Time Frame Baseline and Years 1.5 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 133 126
Mean (Standard Deviation)
Unit of Measure: cubic centimeters (cc)
Baseline, n=133, 126 44.2  (19.17) 43.2  (15.32)
Year 1.5, n=117, 117 43.1  (17.97) 43.3  (15.12)
Year 3, n=118, 118 43.0  (17.94) 43.1  (15.24)
18.Secondary Outcome
Title Change From Baseline in Prostate Volume at Years 1.5 and 3
Hide Description

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.

Time Frame Baseline and Years 1.5 and 3
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Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
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Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 118 118
Mean (Standard Deviation)
Unit of Measure: cc
Year 1.5, n=117, 117 0.7  (11.70) -9.5  (10.51)
Year 3, n=118, 118 3.3  (11.95) -8.6  (10.89)
19.Secondary Outcome
Title Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
Hide Description

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

Time Frame Baseline and Years 1.5 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
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Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 118 118
Mean (Standard Deviation)
Unit of Measure: percent change
Year 1.5, n=117, 117 3.7  (25.24) -19.8  (26.90)
Year 3, n=118, 118 7.7  (25.64) -18.0  (27.98)
20.Secondary Outcome
Title Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Hide Description The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Time Frame Baseline and Month 3, 6, 12, 18, and 36
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Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline, n=151, 146 11.0  (9.28) 11.3  (8.84)
Month 3, n=150, 144 11.4  (8.80) 11.4  (9.71)
Month 6, n=152, 144 10.9  (9.01) 10.4  (9.33)
Month 12, n=152, 144 10.7  (8.82) 9.7  (8.93)
Month 18, n=152, 144 10.5  (8.96) 9.5  (9.43)
Month 18 Take-Home, n=152, 144 11.4  (9.53) 10.6  (9.98)
Month 36, n=152, 144 11.3  (9.56) 9.6  (9.75)
Month 36 Take-Home, n=152, 144 11.5  (9.68) 9.4  (9.85)
21.Secondary Outcome
Title Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Hide Description The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Time Frame Baseline and Months 3, 6, 12, 18, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 148 143
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 3, n=146, 143 0.4  (5.86) 0.3  (7.04)
Month 6, n=148, 143 -0.0  (6.79) -0.8  (7.15)
Month 12, n=148, 143 -0.1  (7.20) -1.4  (7.58)
Month 18, n=148, 143 -0.3  (7.57) -1.6  (8.25)
Month 18 Take-Home, n=148, 143 0.6  (8.39) -0.6  (8.45)
Month 36, n=148, 143 0.5  (8.17) -1.5  (8.30)
Month 36 Take-Home, n=148, 143 0.7  (8.66) -1.8  (8.22)
22.Secondary Outcome
Title Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Hide Description The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Time Frame Baseline and Months 3, 6, 12, 18, and 36
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Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 154 147
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline, n=154, 147 7.1  (6.55) 7.3  (6.35)
Month 3, n=152, 144 7.5  (6.16) 7.5  (6.95)
Month 6, n=152, 144 7.0  (6.49) 6.9  (6.60)
Month 12, n=152, 144 7.0  (6.27) 6.6  (6.46)
Month 18, n=152, 144 6.7  (6.25) 6.4  (6.78)
Month 18 Take-Home, n=152, 144 7.2  (6.75) 7.1  (7.10)
Month 36, n=152,144 7.3  (6.58) 6.5  (6.72)
Month 36 Take-Home, n=152, 144 7.4  (6.64) 6.2  (6.95)
23.Secondary Outcome
Title Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Hide Description The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Time Frame Baseline and Months 3, 6, 12, 18, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 151 144
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 3 0.7  (4.51) 0.3  (5.12)
Month 6 0.1  (5.08) -0.3  (5.53)
Month 12 0.1  (5.28) -0.6  (5.76)
Month 18 -0.2  (5.40) -0.8  (6.08)
Month 18 Take-Home 0.3  (6.10) -0.1  (6.32)
Month 36 0.4  (5.80) -0.7  (5.97)
Month 36 Take-Home 0.5  (5.99) -1.0  (5.91)
24.Secondary Outcome
Title Total MAX-PC Fear of Recurrence Subscale Score
Hide Description The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Time Frame Baseline and Months 3, 6, 12, 18, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 152 144
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline, n=151, 146 3.4  (2.51) 3.4  (2.40)
Month 3, n=150, 144 3.2  (2.59) 3.3  (2.66)
Month 6, n=152, 144 3.3  (2.57) 2.9  (2.39)
Month 12, n=152, 144 3.2  (2.51) 2.6  (2.37)
Month 18, n=152, 144 3.3  (2.52) 2.7  (2.50)
Month 18 Take-Home, n=152, 144 3.4  (2.49) 3.0  (2.70)
Month 36, n=152, 144 3.4  (2.67) 2.7  (2.65)
25.Secondary Outcome
Title Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Hide Description The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Time Frame Baseline and Months 3, 6, 12, 18, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 148 143
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 3, n=146, 143 -0.2  (2.07) -0.0  (2.19)
Month 6, n= 148, 143 -0.2  (2.15) -0.5  (2.13)
Month 12, n=148, 143 -0.1  (2.38) -0.7  (2.24)
Month 18, n=148, 143 -0.1  (2.34) -0.7  (2.31)
Month 18 Take-Home, n=148, 143 0.0  (2.35) -0.3  (2.56)
Month 36, n=148, 143 0.0  (2.32) -0.6  (2.64)
Month 36 Take-Home, n=148, 143 0.0  (2.56) -0.7  (2.55)
26.Secondary Outcome
Title Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Hide Description The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.
Time Frame Baseline and Months 18 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 154 145
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline, n=154, 145 129.9  (17.45) 131.3  (15.07)
Month 18, n=145, 140 126.9  (16.03) 130.2  (16.29)
Month 36, n=149, 140 126.6  (17.00) 129.0  (16.85)
27.Secondary Outcome
Title Change From Baseline in Total FACT-P Score (LOCF)
Hide Description The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Time Frame Baseline and Months 18 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 148 140
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 18, n=144, 140 -4.2  (11.89) -1.2  (14.61)
Month 36, n=148, 140 -3.7  (15.55) -2.3  (15.74)
28.Secondary Outcome
Title Percent Change From Baseline in Total FACT-P Score (LOCF)
Hide Description The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Time Frame Baseline and Months 18 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 148 140
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 18, n=144, 140 -2.8  (10.49) -0.2  (13.44)
Month 36, n=148, 140 -1.8  (16.39) -1.0  (14.16)
29.Secondary Outcome
Title Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
Hide Description The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.
Time Frame Baseline and Months 18 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 149 140
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 18, n=148, 140 -0.4  (2.48) -0.2  (2.28)
Month 36, n=149, 140 -0.3  (2.65) -0.3  (2.58)
30.Secondary Outcome
Title Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
Hide Description The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.
Time Frame Baseline and Months 18 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description:
Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg administered orally once daily for 156 weeks
Overall Number of Participants Analyzed 149 140
Mean (Standard Deviation)
Unit of Measure: points on a scale
Month 18, n=148, 140 -1.4  (5.32) -0.6  (5.95)
Month 36, n=149, 140 -1.1  (6.04) -1.2  (6.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Hide Arm/Group Description Matching placebo 0.5 mg administered orally once daily for 156 weeks Dutasteride 0.5 mg administered orally once daily for 156 weeks
All-Cause Mortality
Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   23/155 (14.84%)   22/147 (14.97%) 
Blood and lymphatic system disorders     
Anaemia  1  1/155 (0.65%)  0/147 (0.00%) 
Cardiac disorders     
Coronary artery disease  1  2/155 (1.29%)  1/147 (0.68%) 
Arrhythmia  1  0/155 (0.00%)  1/147 (0.68%) 
Atrioventricular block complete  1  1/155 (0.65%)  0/147 (0.00%) 
Coronary artery occlusion  1  0/155 (0.00%)  1/147 (0.68%) 
Myocardial infarction  1  0/155 (0.00%)  1/147 (0.68%) 
Myocardial ischaemia  1  0/155 (0.00%)  1/147 (0.68%) 
Cardiac pacemaker replacement  1  1/155 (0.65%)  0/147 (0.00%) 
Gastrointestinal disorders     
Rectal haemorrhage  1  0/155 (0.00%)  2/147 (1.36%) 
Abdominal pain  1  1/155 (0.65%)  0/147 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/155 (0.65%)  0/147 (0.00%) 
Infections and infestations     
Appendicitis perforated  1  1/155 (0.65%)  0/147 (0.00%) 
Celulitis  1  0/155 (0.00%)  1/147 (0.68%) 
Pneumonia  1  1/155 (0.65%)  0/147 (0.00%) 
Urospepsis  1  0/155 (0.00%)  1/147 (0.68%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/155 (0.65%)  0/147 (0.00%) 
Joint dislocation  1  1/155 (0.65%)  0/147 (0.00%) 
Post procedural haemorrhage  1  1/155 (0.65%)  0/147 (0.00%) 
Coronary artery restenosis  1  1/155 (0.65%)  0/147 (0.00%) 
Investigations     
Cardiac murmur  1  1/155 (0.65%)  0/147 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/155 (0.65%)  0/147 (0.00%) 
Gout  1  1/155 (0.65%)  0/147 (0.00%) 
Hyperglycaemia  1  1/155 (0.65%)  0/147 (0.00%) 
Hyponatraemia  1  1/155 (0.65%)  0/147 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/155 (0.65%)  1/147 (0.68%) 
Joint swelling  1  1/155 (0.65%)  0/147 (0.00%) 
Rheumatoid arthritis  1  1/155 (0.65%)  0/147 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/155 (0.00%)  1/147 (0.68%) 
Benign colonic neoplasm  1  0/155 (0.00%)  1/147 (0.68%) 
Bladder cancer  1  0/155 (0.00%)  1/147 (0.68%) 
Bladder cancer stage 0 with cancer in situ  1  0/155 (0.00%)  1/147 (0.68%) 
Bladder transitional cell carcinoma  1  0/155 (0.00%)  1/147 (0.68%) 
Renal cell carcinoma  1  1/155 (0.65%)  0/147 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  1/155 (0.65%)  1/147 (0.68%) 
Cerebral infarction  1  0/155 (0.00%)  1/147 (0.68%) 
Cerebrovascular accident  1  0/155 (0.00%)  1/147 (0.68%) 
Dementia  1  1/155 (0.65%)  0/147 (0.00%) 
Syncope  1  0/155 (0.00%)  1/147 (0.68%) 
Psychiatric disorders     
Depression  1  0/155 (0.00%)  1/147 (0.68%) 
Bipoplar disorder  1  1/155 (0.65%)  0/147 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/155 (0.00%)  1/147 (0.68%) 
Reproductive system and breast disorders     
Prostatitis  1  0/155 (0.00%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/155 (0.65%)  0/147 (0.00%) 
Pulmonary embolism  1  0/155 (0.00%)  1/147 (0.68%) 
Vascular disorders     
Peripheral ischaemia  1  1/155 (0.65%)  0/147 (0.00%) 
Peripheral vascular disorder  1  0/155 (0.00%)  1/147 (0.68%) 
Thrombosis  1  0/155 (0.00%)  1/147 (0.68%) 
Deep vein thrombosis  1  0/155 (0.00%)  1/147 (0.68%) 
Infarction  1  1/155 (0.65%)  0/147 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Matching Placebo 0.5 mg Once Daily Dutasteride 0.5 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   67/155 (43.23%)   56/147 (38.10%) 
General disorders     
Fatigue  1  9/155 (5.81%)  7/147 (4.76%) 
Infections and infestations     
Nasopharyngitis  1  15/155 (9.68%)  8/147 (5.44%) 
Urinary tract infection  1  11/155 (7.10%)  7/147 (4.76%) 
Sinusitis  1  4/155 (2.58%)  8/147 (5.44%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  9/155 (5.81%)  13/147 (8.84%) 
Arthralgia  1  7/155 (4.52%)  8/147 (5.44%) 
Musculoskeletal pain  1  9/155 (5.81%)  4/147 (2.72%) 
Renal and urinary disorders     
Pollakiuria  1  8/155 (5.16%)  3/147 (2.04%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  14/155 (9.03%)  13/147 (8.84%) 
Libido decreased  1  6/155 (3.87%)  10/147 (6.80%) 
Vascular disorders     
Hypertension  1  10/155 (6.45%)  5/147 (3.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363311    
Other Study ID Numbers: AVO105948
First Submitted: August 11, 2006
First Posted: August 15, 2006
Results First Submitted: March 31, 2011
Results First Posted: June 14, 2011
Last Update Posted: January 18, 2017