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Trial record 49 of 117 for:    DUTASTERIDE

ARTS - AVODART After Radical Therapy For Prostate Cancer Study (ARTS)

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ClinicalTrials.gov Identifier: NCT00558363
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : December 13, 2011
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neoplasms, Prostate
Prostate Cancer After a Radical Treatment
Interventions Drug: Avodart
Other: placebo
Enrollment 294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Period Title: Overall Study
Started 147 147
Completed 76 111
Not Completed 71 36
Reason Not Completed
Physician Decision             18             4
Withdrawal by Subject             11             4
Adverse Event             5             5
Lack of Efficacy             2             2
Protocol Violation             2             1
Lost to Follow-up             0             1
Met Protocol-defined Stopping Criteria             32             16
Randomized in Error             1             2
Hospitalized; Unable to Continue             0             1
Arm/Group Title Placebo Dutasteride 0.5 mg Total
Hide Arm/Group Description Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years Oral dose of 0.5 mg dutasteride capsule once daily for 2 years Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 147 participants 294 participants
68.6  (6.53) 69.7  (5.76) 69.1  (6.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
147
 100.0%
147
 100.0%
294
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
White – Caucasian/European Heritage 145 147 292
White – Arabic/North African Heritage 1 0 1
Asian – Central/Soth Asian Heritage 1 0 1
1.Primary Outcome
Title Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)
Hide Description Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants randomized to study treatment. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm; 1 in dutasteride arm). Only participants who experienced PSA doubling (82 in placebo, 41 in dutasteride) contributed to summary statistics.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Median (Full Range)
Unit of Measure: days
Participants (par.) with PSA doubling; n=82, 41
365.5
(90 to 736)
458.0
(91 to 736)
Par. without PSA doubling (censored); n=62, 105
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data were not summarized for participants with censored time.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk (Hazard Ratio)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.23 to 0.50
Estimation Comments Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy
2.Primary Outcome
Title Number of Participants With PSA Doubling From Baseline
Hide Description PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
With PSA doubling 82 41
Without PSA doubling 62 105
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparing percentages of participants with PSA doubling: 57% versus 28%
Method Mantel-Haenszel Chi-Square
Comments [Not Specified]
3.Primary Outcome
Title Time to PSA Doubling From Baseline (in Days) Within Year 1
Hide Description Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.
Time Frame up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Only participants with PSA doubling within Year 1 (50 in placebo, 15 in dutasteride) contributed to summary statistics.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Median (Full Range)
Unit of Measure: days
Participants with PSA doubling in Y1; n=50, 15
273.5
(90 to 486)
183.0
(91 to 383)
Participants without PSA doubling in Y1: n=94, 131
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data were not summarized for participants with censored time.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk (Hazard Ratio)
Estimated Value 0.25
Confidence Interval 95%
0.14 to 0.45
Estimation Comments Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy
4.Primary Outcome
Title Number of Participants With PSA Doubling From Baseline During Year 1
Hide Description PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
Time Frame up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
With PSA doubling 50 15
Without PSA doubling 94 131
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparing percentages of participants with PSA doubling: 35% versus 10%
Method Mantel-Haenszel Chi-Square
Comments [Not Specified]
5.Secondary Outcome
Title Time to Disease Progression From Baseline (in Days)
Hide Description Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)<=91 days, PSA value is at least 50% more than baseline value (>20 nanogram/milliliter [ng/ml] for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with disease progression have been summarized.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 49 25
Median (Full Range)
Unit of Measure: days
365.0
(39 to 824)
285.0
(22 to 808)
6.Secondary Outcome
Title Number of Participants With Disease Progression
Hide Description Disease progression is defined as the first occurrence of any of the following: PSADT<=91 days, PSA value is at least 50% more than baseline value (>20 ng/ml for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
With disease progression 49 25
Without disease progression 95 121
7.Secondary Outcome
Title Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Description Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase <=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.
Time Frame Months 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Par. not having a post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Different par. may contribute data at different time points (TP); the number of par. analyzed at each TP are those with BL as well as post-baseline data at the particular TP.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
Month 3, n=141, 141 64 117
Month 6, n=131, 135 36 105
Month 9, n=121, 129 22 95
Month 12, n=110, 124 13 87
Month 15, n=100, 121 10 82
Month 18, n=95, 120 8 76
Month 21, n=83, 112 7 70
Month 24, n=76, 110 6 62
8.Secondary Outcome
Title Time to PSA Rise From Baseline (in Days)
Hide Description A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with PSA rise have been summarized.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 127 72
Median (Full Range)
Unit of Measure: days
100.0
(39 to 729)
279.0
(22 to 805)
9.Secondary Outcome
Title Number of Participants With a PSA Rise From Baseline
Hide Description A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
With PSA rise 127 72
Without PSA rise 17 74
10.Secondary Outcome
Title Time to PSA Progression (in Days)
Hide Description A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy and PSA >=1.5 times the baseline PSA value, or 0<PSADT<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with PSA progression have been summarized.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 25 19
Median (Full Range)
Unit of Measure: days
368.0
(90 to 736)
368.0
(22 to 735)
11.Secondary Outcome
Title Number of Participants With PSA Progression
Hide Description A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (>10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy) and PSA >=1.5 times the baseline PSA value), or 0<PSADT<=91 days, and all subsequent PSA values satisfied either of these criteria.
Time Frame up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Measure Type: Number
Unit of Measure: participants
With PSA progression 25 19
Without PSA progression 119 127
12.Secondary Outcome
Title Change in Total PSA From Baseline at Months 12 and 24
Hide Description Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time Frame Baseline; Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/ml)
Month 12 2.3  (4.86) 0.9  (7.25)
Month 24 3.9  (6.09) 2.3  (7.60)
13.Secondary Outcome
Title Percent Change in Total PSA From Baseline at Months 12 and 24
Hide Description Percent change in PSA from baseline at Month X = 100*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time Frame Baseline; Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Mean (Standard Deviation)
Unit of Measure: percent change
Month 12 93.1  (115.02) 11.8  (103.41)
Month 24 197.3  (282.41) 86.2  (193.95)
14.Secondary Outcome
Title Change in PSA From Nadir PSA at Months 12 and 24
Hide Description Change from nadir PSA at Month X = Month X PSA – nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time Frame Baseline; Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 146
Mean (Standard Deviation)
Unit of Measure: ng/ml
Month 12 4.7  (6.31) 3.5  (9.04)
Month 24 6.3  (7.34) 4.9  (9.65)
15.Secondary Outcome
Title Percent Change in PSA From Nadir PSA at Months 12 and 24
Hide Description Percent change from nadir PSA at Month X = 100*(Month X PSA – nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time Frame Baseline; Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 94 98
Mean (Standard Deviation)
Unit of Measure: percent change
Month 12 2810.3  (4062.48) 2120.7  (5284.72)
Month 24 4036.1  (5860.98) 2927.2  (6146.34)
16.Secondary Outcome
Title Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)
Hide Description Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.
Time Frame Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants having no baseline (BL) PSADT (due to incomplete PSA data or no rise in PSA at BL) or no post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 3 in dutasteride arm). Participants with missing PSA data at a specific visit were excluded from that visit’s analysis .
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 144
Measure Type: Number
Unit of Measure: participants
Month 12, Worsening; n=110, 123 20 7
Month 12, No change; n=110, 123 0 0
Month 12, Improvement; n=110, 123 90 116
Month 24, Worsening; n=76, 110 7 3
Month 24, No change; n=76, 110 0 0
Month 24, Improvement; n=76, 110 69 107
End-of treatment, Worsening; n=144, 144 37 19
End-of treatment, No change; n=144, 144 0 0
End-of treatment, Improvement; n=144, 144 107 125
17.Secondary Outcome
Title Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Hide Description MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.
Time Frame Baseline; Months 3, 6, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having a baseline value or not having any post-baseline value could not be evaluated for this endpoint and were hence excluded from this analysis (3 in placebo arm, 4 in dutasteride arm). Participants were excluded from a specific visit analysis if the value for the visit (after LOCF application) was missing.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 144 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 3, n=144, 141 -1.6  (0.63) -1.4  (0.63)
Month 6, n=144, 143 -2.2  (0.63) -3.1  (0.62)
Month 12, n=144, 143 -0.8  (0.72) -2.9  (0.72)
Month 18, n=144, 143 -1.1  (0.79) -2.2  (0.78)
Month 24, n=144, 143 -0.4  (0.78) -1.4  (0.77)
18.Secondary Outcome
Title Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study
Hide Description A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.
Time Frame Baseline; up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having any baseline measurements, or having a baseline but no post-baseline measurements of at least one of the same parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 140 138
Measure Type: Number
Unit of Measure: participants
74 64
19.Secondary Outcome
Title Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline
Hide Description Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory’s normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.
Time Frame Baseline; up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one laboratory parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 140 138
Measure Type: Number
Unit of Measure: participants
Threshold at BL 5 9
Non-threshold at BL; threshold at any time post-BL 11 5
20.Secondary Outcome
Title Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline
Hide Description Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
Time Frame Baseline; up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with PBT at baseline or PBT at any time post-baseline were measured for clinical significance.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
BL; PBT, n=147, 147 6 4
BL; Clinically significant (CS) PBT, n=6, 4 0 0
No BL PBT, but PBT at any time post-BL, n=147,147 10 21
CS change in PBT; BL to any time post-BL, n=10, 21 0 4
21.Secondary Outcome
Title Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline
Hide Description Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
Time Frame Baseline; up to 28 months
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Hide Analysis Population Description
ITT Population. Only those participants with NT at baseline or NT at any time post-baseline were measured for clinical significance.
Arm/Group Title Placebo Dutasteride 0.5 mg
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Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
BL; NT, n=147, 147 0 3
BL; Clinically significant (CS) NT, n=0, 3 0 0
No NT at BL, but NT at any time post-BL, n=147,147 8 11
CS change in NT; BL to any time post-BL, n=8, 11 0 1
22.Secondary Outcome
Title Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline
Hide Description Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.
Time Frame Baseline; up to 28 months
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Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
10 8
23.Secondary Outcome
Title Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline
Hide Description Threshold vital signs are defined as follows: < 80 mmHg or > 165 mmHg for systolic blood pressure; < 40 mmHg or > 105 mm Hg for diastolic blood pressure, < 40 beats per minute (bpm) or > 100 bpm for heart rate.
Time Frame Baseline; up to 28 months
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Hide Analysis Population Description
ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one vital sign parameter were excluded from this analysis (6 in placebo arm, 4 in dutasteride arm).
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Overall Number of Participants Analyzed 141 143
Measure Type: Number
Unit of Measure: participants
Baseline 18 15
Any time post-baseline 37 36
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to the End of Study (up to 28 months after treatment start).
Adverse Event Reporting Description All safety analyses were performed using the ITT Population.
 
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
All-Cause Mortality
Placebo Dutasteride 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dutasteride 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   16/147 (10.88%)   16/147 (10.88%) 
Blood and lymphatic system disorders     
Anaemia  1  0/147 (0.00%)  1/147 (0.68%) 
Cardiac disorders     
Arrhythmia  1  1/147 (0.68%)  1/147 (0.68%) 
Atrial fibrillation  1  1/147 (0.68%)  1/147 (0.68%) 
Cardiac failure congestive  1  0/147 (0.00%)  1/147 (0.68%) 
Myocardial infarction  1  0/147 (0.00%)  1/147 (0.68%) 
Sinus bradycardia  1  0/147 (0.00%)  1/147 (0.68%) 
Ventricular tachycardia  1  1/147 (0.68%)  0/147 (0.00%) 
Acute coronary syndrome  1  1/147 (0.68%)  0/147 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  1/147 (0.68%)  0/147 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/147 (0.00%)  1/147 (0.68%) 
Gastric ulcer  1  1/147 (0.68%)  0/147 (0.00%) 
Inguinal hernia  1  0/147 (0.00%)  1/147 (0.68%) 
Abdominal wall haematoma  1  0/147 (0.00%)  1/147 (0.68%) 
General disorders     
Gait disturbance  1  1/147 (0.68%)  0/147 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  0/147 (0.00%)  1/147 (0.68%) 
Infections and infestations     
Gastroenteritis  1  0/147 (0.00%)  1/147 (0.68%) 
Hepatitis C  1  0/147 (0.00%)  1/147 (0.68%) 
Skin infection  1  1/147 (0.68%)  0/147 (0.00%) 
Urethral abscess  1  1/147 (0.68%)  0/147 (0.00%) 
Bacterial infection  1  1/147 (0.68%)  0/147 (0.00%) 
Respiratory tract infection  1  0/147 (0.00%)  1/147 (0.68%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/147 (0.00%)  1/147 (0.68%) 
Spinal fracture  1  1/147 (0.68%)  0/147 (0.00%) 
Subdural haematoma  1  1/147 (0.68%)  0/147 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/147 (0.68%)  0/147 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to liver  1  1/147 (0.68%)  1/147 (0.68%) 
Bladder cancer  1  1/147 (0.68%)  0/147 (0.00%) 
Bladder cancer recurrent  1  1/147 (0.68%)  0/147 (0.00%) 
Bladder neoplasm  1  0/147 (0.00%)  1/147 (0.68%) 
Hepatic neoplasm malignant  1  0/147 (0.00%)  1/147 (0.68%) 
Metastases to bone  1  1/147 (0.68%)  0/147 (0.00%) 
Neoplasm malignant  1  0/147 (0.00%)  1/147 (0.68%) 
Prostate cancer metastatic  1  1/147 (0.68%)  0/147 (0.00%) 
Lung cancer metastatic  1  1/147 (0.68%)  0/147 (0.00%) 
Non-small cell lung cancer  1  1/147 (0.68%)  0/147 (0.00%) 
Nervous system disorders     
Dizziness  1  1/147 (0.68%)  0/147 (0.00%) 
Intracranial aneurysm  1  1/147 (0.68%)  0/147 (0.00%) 
Transient ischaemic attack  1  0/147 (0.00%)  1/147 (0.68%) 
Balance disorder  1  0/147 (0.00%)  1/147 (0.68%) 
Central nervous system lesion  1  1/147 (0.68%)  0/147 (0.00%) 
Cognitive disorder  1  1/147 (0.68%)  0/147 (0.00%) 
Renal and urinary disorders     
Bladder neck sclerosis  1  1/147 (0.68%)  0/147 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/147 (0.00%)  1/147 (0.68%) 
Chronic obstructive pulmonary disease  1  0/147 (0.00%)  1/147 (0.68%) 
Dyspnoea  1  0/147 (0.00%)  1/147 (0.68%) 
Pulmonary embolism  1  0/147 (0.00%)  1/147 (0.68%) 
Vascular disorders     
Shock  1  0/147 (0.00%)  1/147 (0.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dutasteride 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   31/147 (21.09%)   32/147 (21.77%) 
Infections and infestations     
Nasopharyngitis  1  10/147 (6.80%)  14/147 (9.52%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  11/147 (7.48%)  4/147 (2.72%) 
Renal and urinary disorders     
Urinary incontinence  1  4/147 (2.72%)  8/147 (5.44%) 
Reproductive system and breast disorders     
Gynaecomastia  1  4/147 (2.72%)  10/147 (6.80%) 
Vascular disorders     
Hypertension  1  10/147 (6.80%)  4/147 (2.72%) 
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: NCT00558363     History of Changes
Other Study ID Numbers: ARI109924
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: November 10, 2011
Results First Posted: December 13, 2011
Last Update Posted: March 21, 2012