Trial Outcomes & Findings for Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men (NCT NCT00363311)
NCT ID: NCT00363311
Last Updated: 2017-01-18
Results Overview
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.
COMPLETED
PHASE4
302 participants
Year 1.5 and Overall (Years 0-3)
2017-01-18
Participant Flow
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.
Participant milestones
| Measure |
Matching Placebo 0.5 mg Once Daily
Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
147
|
|
Overall Study
COMPLETED
|
79
|
102
|
|
Overall Study
NOT COMPLETED
|
76
|
45
|
Reasons for withdrawal
| Measure |
Matching Placebo 0.5 mg Once Daily
Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
6
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Sponsor Terminated Study
|
2
|
2
|
|
Overall Study
Disease Progression
|
46
|
26
|
|
Overall Study
Non-Compliance
|
1
|
1
|
|
Overall Study
Participant Refused Biopsy
|
1
|
0
|
|
Overall Study
Prostate Volume/PSA Doubled
|
1
|
0
|
|
Overall Study
Participant Opted for Treatment
|
1
|
0
|
|
Overall Study
Participant Moved to Another Country
|
1
|
0
|
|
Overall Study
Participant Withdrew Waiting for Surgery
|
0
|
1
|
|
Overall Study
Withdrawn per Instructions of Monitor
|
0
|
1
|
|
Overall Study
Participant Moved to Louisiana
|
0
|
1
|
Baseline Characteristics
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
Baseline characteristics by cohort
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 Years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 7.13 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
155 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
141 participants
n=5 Participants
|
132 participants
n=7 Participants
|
273 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White and American Indian/Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Year 1.5 and Overall (Years 0-3)Population: 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.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
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
Year 1.5, n=144, 142
|
50 participants
|
32 participants
|
|
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
Overall (Years 0-3), n= 155, 147
|
71 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Year 1.5 and Overall (Years 0-3)Population: ITT Population
Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Participants With Therapeutic Progression
Overall (Years 0-3)
|
20 participants
|
11 participants
|
|
Number of Participants With Therapeutic Progression
Year 1.5
|
11 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Year 1.5 and Overall (Years 0-3)Population: 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.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=136 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Participants With Pathologic Progression
Year 1.5, n= 136, 139
|
39 participants
|
27 participants
|
|
Number of Participants With Pathologic Progression
Overall (Years 0-3) n=136, 140
|
51 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=136 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
Participants with a PCa diagnosis
|
111 participants
|
111 participants
|
|
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
Participants with no PCa diagnosis
|
25 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Years 0-3Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=136 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
Participants with a PCa diagnosis
|
105 participants
|
90 participants
|
|
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
Participants with no PCa diagnosis
|
31 participants
|
50 participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Cancer-positive Cores in a 12-core Biopsy
Years 0-3 (Final biopsy), n=105, 90
|
3.0 cores
Standard Deviation 2.03
|
2.5 cores
Standard Deviation 1.25
|
|
Number of Cancer-positive Cores in a 12-core Biopsy
Baseline, n=155, 147
|
1.6 cores
Standard Deviation 0.74
|
1.6 cores
Standard Deviation 0.72
|
|
Number of Cancer-positive Cores in a 12-core Biopsy
Year 1.5, n=87, 99
|
2.8 cores
Standard Deviation 1.82
|
2.2 cores
Standard Deviation 1.25
|
|
Number of Cancer-positive Cores in a 12-core Biopsy
Year 3, n=52, 54
|
2.0 cores
Standard Deviation 1.17
|
2.0 cores
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=105 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=90 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Year 3, n=52, 54
|
2.0 cores
Standard Deviation 1.17
|
2.0 cores
Standard Deviation 0.95
|
|
Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Year 1.5, n= 87, 99
|
1.1 cores
Standard Deviation 1.63
|
0.6 cores
Standard Deviation 1.36
|
|
Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Years 0-3 (Final biopsy), n=105, 90
|
3.0 cores
Standard Deviation 2.03
|
2.5 cores
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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).
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Baseline, n= 155, 147
|
14.3 percentage of cores
Standard Deviation 7.30
|
14.5 percentage of cores
Standard Deviation 6.95
|
|
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Year 1.5, n=87, 99
|
23.7 percentage of cores
Standard Deviation 15.76
|
19.0 percentage of cores
Standard Deviation 10.66
|
|
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Year 3, n=52, 54
|
16.5 percentage of cores
Standard Deviation 9.71
|
17.3 percentage of cores
Standard Deviation 8.44
|
|
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Years 0-3 (Final biopsy), n=105, 90
|
24.7 percentage of cores
Standard Deviation 15.66
|
21.7 percentage of cores
Standard Deviation 10.76
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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).
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=105 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=90 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Year 3, n=52, 54
|
4.1 percentage of cores
Standard Deviation 9.84
|
1.5 percentage of cores
Standard Deviation 10.03
|
|
Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Year 1.5, n= 87, 99
|
8.4 percentage of cores
Standard Deviation 13.73
|
3.7 percentage of cores
Standard Deviation 11.97
|
|
Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
Years 0-3 (Final biopsy), n=105, 90
|
10.0 percentage of cores
Standard Deviation 13.88
|
6.0 percentage of cores
Standard Deviation 11.40
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Cumulative Length of Cancer Tumor Core
Year 3, n=52, 54
|
3.7 millimeters
Standard Deviation 3.82
|
3.8 millimeters
Standard Deviation 3.51
|
|
Cumulative Length of Cancer Tumor Core
Baseline, n= 155, 147
|
2.0 millimeters
Standard Deviation 1.86
|
2.1 millimeters
Standard Deviation 2.04
|
|
Cumulative Length of Cancer Tumor Core
Year 1.5, n=87, 99
|
6.2 millimeters
Standard Deviation 5.99
|
4.8 millimeters
Standard Deviation 6.34
|
|
Cumulative Length of Cancer Tumor Core
Years 0-3 (Final biopsy), n=105, 90
|
7.0 millimeters
Standard Deviation 7.02
|
6.1 millimeters
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=105 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=90 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
Year 1.5, n= 87, 99
|
3.9 millimeters
Standard Deviation 5.71
|
2.5 millimeters
Standard Deviation 6.59
|
|
Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
Year 3, n=52, 54
|
1.8 millimeters
Standard Deviation 3.94
|
1.5 millimeters
Standard Deviation 3.58
|
|
Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
Years 0-3 (Final biopsy), n=105, 90
|
4.8 millimeters
Standard Deviation 6.70
|
3.8 millimeters
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Year 1.5Population: ITT Population. As the study progressed, participants dropped out of the study.
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).
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=81 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=100 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
Improvement
|
6 participants
|
21 participants
|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
No change
|
51 participants
|
58 participants
|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
Worsening
|
24 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Years 0-3 (Final Biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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).
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=136 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
Worsening
|
22 participants
|
19 participants
|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
Improvement
|
31 participants
|
50 participants
|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
No cancer, GS 0
|
31 participants
|
50 participants
|
|
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
No change
|
83 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Years 0-3 (Final Biopsy)Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=136 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Participants With the Indicated Total Gleason Score
GS 7, 3 (primary grade) + 4 (secondary grade)
|
15 participants
|
13 participants
|
|
Number of Participants With the Indicated Total Gleason Score
Missing (No Cancer)
|
31 participants
|
50 participants
|
|
Number of Participants With the Indicated Total Gleason Score
GS 5
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Total Gleason Score
GS 6
|
83 participants
|
71 participants
|
|
Number of Participants With the Indicated Total Gleason Score
GS 7, 4 (primary grade) + 3 (secondary grade)
|
4 participants
|
4 participants
|
|
Number of Participants With the Indicated Total Gleason Score
GS 8
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Total Gleason Score
GS 9-10
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT Population
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
T2c
|
0 biopsies
|
1 biopsies
|
|
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
T1c
|
125 biopsies
|
117 biopsies
|
|
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
T2a
|
30 biopsies
|
29 biopsies
|
SECONDARY outcome
Timeframe: Months 0-18Population: ITT Population. As the study progressed, participants dropped out of the study.
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."
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=66 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=58 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
No Worsening (same/lower stage)
|
53 biopsies
|
53 biopsies
|
|
Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
Worsening (higher stage)
|
13 biopsies
|
5 biopsies
|
SECONDARY outcome
Timeframe: Baseline and Years 1.5 and 3Population: ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=133 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=126 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Prostate Volume (PV) LOCF
Baseline, n=133, 126
|
44.2 cubic centimeters (cc)
Standard Deviation 19.17
|
43.2 cubic centimeters (cc)
Standard Deviation 15.32
|
|
Prostate Volume (PV) LOCF
Year 1.5, n=117, 117
|
43.1 cubic centimeters (cc)
Standard Deviation 17.97
|
43.3 cubic centimeters (cc)
Standard Deviation 15.12
|
|
Prostate Volume (PV) LOCF
Year 3, n=118, 118
|
43.0 cubic centimeters (cc)
Standard Deviation 17.94
|
43.1 cubic centimeters (cc)
Standard Deviation 15.24
|
SECONDARY outcome
Timeframe: Baseline and Years 1.5 and 3Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=118 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=118 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in Prostate Volume at Years 1.5 and 3
Year 1.5, n=117, 117
|
0.7 cc
Standard Deviation 11.70
|
-9.5 cc
Standard Deviation 10.51
|
|
Change From Baseline in Prostate Volume at Years 1.5 and 3
Year 3, n=118, 118
|
3.3 cc
Standard Deviation 11.95
|
-8.6 cc
Standard Deviation 10.89
|
SECONDARY outcome
Timeframe: Baseline and Years 1.5 and 3Population: ITT Population. As the study progressed, participants dropped out of the study.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=118 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=118 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
Year 1.5, n=117, 117
|
3.7 percent change
Standard Deviation 25.24
|
-19.8 percent change
Standard Deviation 26.90
|
|
Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
Year 3, n=118, 118
|
7.7 percent change
Standard Deviation 25.64
|
-18.0 percent change
Standard Deviation 27.98
|
SECONDARY outcome
Timeframe: Baseline and Month 3, 6, 12, 18, and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=151 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=146 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Baseline, n=151, 146
|
11.0 points on a scale
Standard Deviation 9.28
|
11.3 points on a scale
Standard Deviation 8.84
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 3, n=150, 144
|
11.4 points on a scale
Standard Deviation 8.80
|
11.4 points on a scale
Standard Deviation 9.71
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 6, n=152, 144
|
10.9 points on a scale
Standard Deviation 9.01
|
10.4 points on a scale
Standard Deviation 9.33
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 12, n=152, 144
|
10.7 points on a scale
Standard Deviation 8.82
|
9.7 points on a scale
Standard Deviation 8.93
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 18, n=152, 144
|
10.5 points on a scale
Standard Deviation 8.96
|
9.5 points on a scale
Standard Deviation 9.43
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 18 Take-Home, n=152, 144
|
11.4 points on a scale
Standard Deviation 9.53
|
10.6 points on a scale
Standard Deviation 9.98
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 36, n=152, 144
|
11.3 points on a scale
Standard Deviation 9.56
|
9.6 points on a scale
Standard Deviation 9.75
|
|
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Month 36 Take-Home, n=152, 144
|
11.5 points on a scale
Standard Deviation 9.68
|
9.4 points on a scale
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 36Population: 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.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=148 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=143 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 18, n=148, 143
|
-0.3 points on a scale
Standard Deviation 7.57
|
-1.6 points on a scale
Standard Deviation 8.25
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 3, n=146, 143
|
0.4 points on a scale
Standard Deviation 5.86
|
0.3 points on a scale
Standard Deviation 7.04
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 6, n=148, 143
|
-0.0 points on a scale
Standard Deviation 6.79
|
-0.8 points on a scale
Standard Deviation 7.15
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 12, n=148, 143
|
-0.1 points on a scale
Standard Deviation 7.20
|
-1.4 points on a scale
Standard Deviation 7.58
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 18 Take-Home, n=148, 143
|
0.6 points on a scale
Standard Deviation 8.39
|
-0.6 points on a scale
Standard Deviation 8.45
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 36, n=148, 143
|
0.5 points on a scale
Standard Deviation 8.17
|
-1.5 points on a scale
Standard Deviation 8.30
|
|
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Month 36 Take-Home, n=148, 143
|
0.7 points on a scale
Standard Deviation 8.66
|
-1.8 points on a scale
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=154 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 36, n=152,144
|
7.3 points on a scale
Standard Deviation 6.58
|
6.5 points on a scale
Standard Deviation 6.72
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Baseline, n=154, 147
|
7.1 points on a scale
Standard Deviation 6.55
|
7.3 points on a scale
Standard Deviation 6.35
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 3, n=152, 144
|
7.5 points on a scale
Standard Deviation 6.16
|
7.5 points on a scale
Standard Deviation 6.95
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 6, n=152, 144
|
7.0 points on a scale
Standard Deviation 6.49
|
6.9 points on a scale
Standard Deviation 6.60
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 12, n=152, 144
|
7.0 points on a scale
Standard Deviation 6.27
|
6.6 points on a scale
Standard Deviation 6.46
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 18, n=152, 144
|
6.7 points on a scale
Standard Deviation 6.25
|
6.4 points on a scale
Standard Deviation 6.78
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 18 Take-Home, n=152, 144
|
7.2 points on a scale
Standard Deviation 6.75
|
7.1 points on a scale
Standard Deviation 7.10
|
|
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Month 36 Take-Home, n=152, 144
|
7.4 points on a scale
Standard Deviation 6.64
|
6.2 points on a scale
Standard Deviation 6.95
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=151 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=144 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 3
|
0.7 points on a scale
Standard Deviation 4.51
|
0.3 points on a scale
Standard Deviation 5.12
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 6
|
0.1 points on a scale
Standard Deviation 5.08
|
-0.3 points on a scale
Standard Deviation 5.53
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 12
|
0.1 points on a scale
Standard Deviation 5.28
|
-0.6 points on a scale
Standard Deviation 5.76
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 18
|
-0.2 points on a scale
Standard Deviation 5.40
|
-0.8 points on a scale
Standard Deviation 6.08
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 18 Take-Home
|
0.3 points on a scale
Standard Deviation 6.10
|
-0.1 points on a scale
Standard Deviation 6.32
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 36
|
0.4 points on a scale
Standard Deviation 5.80
|
-0.7 points on a scale
Standard Deviation 5.97
|
|
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Month 36 Take-Home
|
0.5 points on a scale
Standard Deviation 5.99
|
-1.0 points on a scale
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=152 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=144 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Total MAX-PC Fear of Recurrence Subscale Score
Baseline, n=151, 146
|
3.4 points on a scale
Standard Deviation 2.51
|
3.4 points on a scale
Standard Deviation 2.40
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 3, n=150, 144
|
3.2 points on a scale
Standard Deviation 2.59
|
3.3 points on a scale
Standard Deviation 2.66
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 6, n=152, 144
|
3.3 points on a scale
Standard Deviation 2.57
|
2.9 points on a scale
Standard Deviation 2.39
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 12, n=152, 144
|
3.2 points on a scale
Standard Deviation 2.51
|
2.6 points on a scale
Standard Deviation 2.37
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 18, n=152, 144
|
3.3 points on a scale
Standard Deviation 2.52
|
2.7 points on a scale
Standard Deviation 2.50
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 18 Take-Home, n=152, 144
|
3.4 points on a scale
Standard Deviation 2.49
|
3.0 points on a scale
Standard Deviation 2.70
|
|
Total MAX-PC Fear of Recurrence Subscale Score
Month 36, n=152, 144
|
3.4 points on a scale
Standard Deviation 2.67
|
2.7 points on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, and 36Population: 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.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=148 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=143 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 36 Take-Home, n=148, 143
|
0.0 points on a scale
Standard Deviation 2.56
|
-0.7 points on a scale
Standard Deviation 2.55
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 3, n=146, 143
|
-0.2 points on a scale
Standard Deviation 2.07
|
-0.0 points on a scale
Standard Deviation 2.19
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 6, n= 148, 143
|
-0.2 points on a scale
Standard Deviation 2.15
|
-0.5 points on a scale
Standard Deviation 2.13
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 12, n=148, 143
|
-0.1 points on a scale
Standard Deviation 2.38
|
-0.7 points on a scale
Standard Deviation 2.24
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 18, n=148, 143
|
-0.1 points on a scale
Standard Deviation 2.34
|
-0.7 points on a scale
Standard Deviation 2.31
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 18 Take-Home, n=148, 143
|
0.0 points on a scale
Standard Deviation 2.35
|
-0.3 points on a scale
Standard Deviation 2.56
|
|
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Month 36, n=148, 143
|
0.0 points on a scale
Standard Deviation 2.32
|
-0.6 points on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=154 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=145 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Baseline, n=154, 145
|
129.9 points on a scale
Standard Deviation 17.45
|
131.3 points on a scale
Standard Deviation 15.07
|
|
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Month 18, n=145, 140
|
126.9 points on a scale
Standard Deviation 16.03
|
130.2 points on a scale
Standard Deviation 16.29
|
|
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Month 36, n=149, 140
|
126.6 points on a scale
Standard Deviation 17.00
|
129.0 points on a scale
Standard Deviation 16.85
|
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: 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.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=148 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in Total FACT-P Score (LOCF)
Month 18, n=144, 140
|
-4.2 points on a scale
Standard Deviation 11.89
|
-1.2 points on a scale
Standard Deviation 14.61
|
|
Change From Baseline in Total FACT-P Score (LOCF)
Month 36, n=148, 140
|
-3.7 points on a scale
Standard Deviation 15.55
|
-2.3 points on a scale
Standard Deviation 15.74
|
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=148 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total FACT-P Score (LOCF)
Month 18, n=144, 140
|
-2.8 points on a scale
Standard Deviation 10.49
|
-0.2 points on a scale
Standard Deviation 13.44
|
|
Percent Change From Baseline in Total FACT-P Score (LOCF)
Month 36, n=148, 140
|
-1.8 points on a scale
Standard Deviation 16.39
|
-1.0 points on a scale
Standard Deviation 14.16
|
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=149 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
Month 18, n=148, 140
|
-0.4 points on a scale
Standard Deviation 2.48
|
-0.2 points on a scale
Standard Deviation 2.28
|
|
Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
Month 36, n=149, 140
|
-0.3 points on a scale
Standard Deviation 2.65
|
-0.3 points on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline and Months 18 and 36Population: ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.
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.
Outcome measures
| Measure |
Matching Placebo 0.5 mg Once Daily
n=149 Participants
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=140 Participants
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
Month 18, n=148, 140
|
-1.4 points on a scale
Standard Deviation 5.32
|
-0.6 points on a scale
Standard Deviation 5.95
|
|
Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
Month 36, n=149, 140
|
-1.1 points on a scale
Standard Deviation 6.04
|
-1.2 points on a scale
Standard Deviation 6.59
|
Adverse Events
Matching Placebo 0.5 mg Once Daily
Dutasteride 0.5 mg Once Daily
Serious adverse events
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 participants at risk
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 participants at risk
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/155
|
0.68%
1/147
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/155
|
0.68%
1/147
|
|
Cardiac disorders
Atrioventricular block complete
|
0.65%
1/155
|
0.00%
0/147
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/155
|
0.68%
1/147
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/155
|
0.68%
1/147
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/155
|
0.68%
1/147
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/155
|
0.68%
1/147
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/155
|
0.68%
1/147
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/155
|
0.68%
1/147
|
|
Nervous system disorders
Dementia
|
0.65%
1/155
|
0.00%
0/147
|
|
Nervous system disorders
Syncope
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0 with cancer in situ
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/155
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.65%
1/155
|
0.00%
0/147
|
|
Vascular disorders
Peripheral ischaemia
|
0.65%
1/155
|
0.00%
0/147
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/155
|
0.68%
1/147
|
|
Vascular disorders
Thrombosis
|
0.00%
0/155
|
0.68%
1/147
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/155
|
0.68%
1/147
|
|
Vascular disorders
Infarction
|
0.65%
1/155
|
0.00%
0/147
|
|
Infections and infestations
Appendicitis perforated
|
0.65%
1/155
|
0.00%
0/147
|
|
Infections and infestations
Celulitis
|
0.00%
0/155
|
0.68%
1/147
|
|
Infections and infestations
Pneumonia
|
0.65%
1/155
|
0.00%
0/147
|
|
Infections and infestations
Urospepsis
|
0.00%
0/155
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.65%
1/155
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.65%
1/155
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.65%
1/155
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.65%
1/155
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/155
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.65%
1/155
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.65%
1/155
|
0.00%
0/147
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/155
|
1.4%
2/147
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/155
|
0.00%
0/147
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.65%
1/155
|
0.00%
0/147
|
|
Metabolism and nutrition disorders
Gout
|
0.65%
1/155
|
0.00%
0/147
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.65%
1/155
|
0.00%
0/147
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/155
|
0.00%
0/147
|
|
Psychiatric disorders
Depression
|
0.00%
0/155
|
0.68%
1/147
|
|
Psychiatric disorders
Bipoplar disorder
|
0.65%
1/155
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/155
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/155
|
0.68%
1/147
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/155
|
0.00%
0/147
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
1/155
|
0.00%
0/147
|
|
Investigations
Cardiac murmur
|
0.65%
1/155
|
0.00%
0/147
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/155
|
0.68%
1/147
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/155
|
0.68%
1/147
|
|
Cardiac disorders
Cardiac pacemaker replacement
|
0.65%
1/155
|
0.00%
0/147
|
Other adverse events
| Measure |
Matching Placebo 0.5 mg Once Daily
n=155 participants at risk
Matching placebo 0.5 mg administered orally once daily for 156 weeks
|
Dutasteride 0.5 mg Once Daily
n=147 participants at risk
Dutasteride 0.5 mg administered orally once daily for 156 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
9.0%
14/155
|
8.8%
13/147
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
15/155
|
5.4%
8/147
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
9/155
|
8.8%
13/147
|
|
Infections and infestations
Urinary tract infection
|
7.1%
11/155
|
4.8%
7/147
|
|
General disorders
Fatigue
|
5.8%
9/155
|
4.8%
7/147
|
|
Reproductive system and breast disorders
Libido decreased
|
3.9%
6/155
|
6.8%
10/147
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
7/155
|
5.4%
8/147
|
|
Vascular disorders
Hypertension
|
6.5%
10/155
|
3.4%
5/147
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
9/155
|
2.7%
4/147
|
|
Infections and infestations
Sinusitis
|
2.6%
4/155
|
5.4%
8/147
|
|
Renal and urinary disorders
Pollakiuria
|
5.2%
8/155
|
2.0%
3/147
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER