Trial Outcomes & Findings for Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement (NCT NCT01294592)

Last Updated: 2018-08-20

Results Overview

The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

742 participants

Primary outcome timeframe

Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Results posted on

2018-08-20

Participant Flow

Treatment-naïve men with symptomatic benign prostatic hyperplasia (BPH) meeting eligibility criteria were enrolled and were randomized in a 1:1 ratio to receive dutasteride plus tamsulosin once daily plus lifestyle advice or watchful waiting plus lifestyle advice.

Participant milestones

Participant milestones
Measure	Dutasteride Plus Tamsulosin Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Study STARTED	369	373
Overall Study COMPLETED	292	300
Overall Study NOT COMPLETED	77	73

Reasons for withdrawal

Reasons for withdrawal
Measure	Dutasteride Plus Tamsulosin Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Study Adverse Event	28	13
Overall Study Lack of Efficacy	7	5
Overall Study Protocol Violation	1	7
Overall Study Lost to Follow-up	7	9
Overall Study Physician Decision	6	11
Overall Study Withdrawal by Subject	28	28

Baseline Characteristics

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dutasteride Plus Tamsulosin n=369 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Total n=742 Participants Total of all reporting groups
Age, Continuous	66.3 Years STANDARD_DEVIATION 7.78 • n=5 Participants	66.2 Years STANDARD_DEVIATION 7.34 • n=7 Participants	66.2 Years STANDARD_DEVIATION 7.56 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	369 Participants n=5 Participants	373 Participants n=7 Participants	742 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	357 Participants n=5 Participants	363 Participants n=7 Participants	720 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=368 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 1, n=358, 367	-3.2 Scores on a scale Standard Error 0.21	-0.9 Scores on a scale Standard Error 0.20	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 3, n=359, 368	-4.5 Scores on a scale Standard Error 0.22	-2.4 Scores on a scale Standard Error 0.22	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 6, n=359, 368	-4.6 Scores on a scale Standard Error 0.23	-3.2 Scores on a scale Standard Error 0.22	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 9, n=359, 368	-5.1 Scores on a scale Standard Error 0.22	-3.6 Scores on a scale Standard Error 0.22	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 12, n=359, 368	-5.2 Scores on a scale Standard Error 0.23	-3.6 Scores on a scale Standard Error 0.23	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 15, n=359, 368	-5.2 Scores on a scale Standard Error 0.25	-3.6 Scores on a scale Standard Error 0.24	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 18, n=359, 368	-5.1 Scores on a scale Standard Error 0.25	-3.3 Scores on a scale Standard Error 0.25	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 21, n=359, 368	-5.5 Scores on a scale Standard Error 0.25	-3.6 Scores on a scale Standard Error 0.24	—
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach Month 24, n=359, 368	-5.4 Scores on a scale Standard Error 0.25	-3.6 Scores on a scale Standard Error 0.25	—

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.

Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: \>=1 point through \>=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: \>0 percent, \>=10 percent, \>=20 percent, \>=25 percent, \>=30 percent, \>=40 percent, and \>=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: \>=2 points, \>=3 points, and percent change \>=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=368 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, >=2 points, n=358, 367	225 Participants	149 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, >=3 points, n=358, 367	182 Participants	90 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, >=25 percent, n=358, 367	161 Participants	76 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, >=2 points, n=359, 368	277 Participants	221 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, >=3 points, n=359, 368	233 Participants	172 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, >=25 percent, n= 359, 368	218 Participants	150 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, >=2 points, n=359, 368	277 Participants	250 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, >=3 points, n=359, 368	245 Participants	208 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, >=25 percent, n=359, 368	229 Participants	189 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, >=2 points, n=359, 368	286 Participants	276 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, >=3 points, n=359, 368	257 Participants	222 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, >=25 percent, n=359, 368	247 Participants	207 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, >=2 points, n=359, 368	291 Participants	273 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, >=3 points, n=359, 368	261 Participants	229 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, >=25 percent, n= 359, 368	249 Participants	214 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, >=2 points, n=359, 368	289 Participants	275 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, >=3 points, n=359, 368	259 Participants	243 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, >=25 percent, n=359, 368	245 Participants	231 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, >=2 points, n=359, 368	288 Participants	268 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, >=3 points, n=359, 368	262 Participants	229 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, >=25 percent, 359, 368	245 Participants	212 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, >=2 points, n=359, 368	292 Participants	274 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, >=3 points, n=359, 368	267 Participants	237 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, >=25 percent, n= 359, 368	253 Participants	224 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, >=2 points, n=359, 368	295 Participants	279 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, >=3points, n=359, 368	277 Participants	234 Participants	—
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, >=25 percent, n= 359, 368	261 Participants	221 Participants	—

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.

The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=368 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, n=357, 366	-1.3 Scores on a scale Standard Error 0.11	-0.4 Scores on a scale Standard Error 0.11	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, n=359, 368	-1.8 Scores on a scale Standard Error 0.11	-1.0 Scores on a scale Standard Error 0.11	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, n=359, 368	-1.9 Scores on a scale Standard Error 0.11	-1.3 Scores on a scale Standard Error 0.11	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, n=359, 368	-2.1 Scores on a scale Standard Error 0.11	-1.5 Scores on a scale Standard Error 0.11	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, n=359, 368	-2.1 Scores on a scale Standard Error 0.12	-1.5 Scores on a scale Standard Error 0.12	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, n=359, 368	-2.2 Scores on a scale Standard Error 0.12	-1.5 Scores on a scale Standard Error 0.12	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, n=359, 368	-2.2 Scores on a scale Standard Error 0.12	-1.4 Scores on a scale Standard Error 0.12	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, n=359, 368	-2.4 Scores on a scale Standard Error 0.12	-1.6 Scores on a scale Standard Error 0.12	—
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, n=359, 368	-2.4 Scores on a scale Standard Error 0.12	-1.6 Scores on a scale Standard Error 0.12	—

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.

Each participant was asked the following question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". This response was rated from 0 ("delighted") to 6 ("terrible"). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=368 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, n=358, 367	-0.8 Scores on a scale Standard Error 0.06	-0.3 Scores on a scale Standard Error 0.05	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, n=359, 368	-1.1 Scores on a scale Standard Error 0.06	-0.7 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, n=359, 368	-1.2 Scores on a scale Standard Error 0.06	-0.9 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, n=359, 368	-1.3 Scores on a scale Standard Error 0.06	-1.0 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, n=359, 368	-1.3 Scores on a scale Standard Error 0.06	-1.1 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, n=359, 368	-1.4 Scores on a scale Standard Error 0.06	-1.1 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, n=359, 368	-1.4 Scores on a scale Standard Error 0.06	-1.1 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, n=359, 368	-1.5 Scores on a scale Standard Error 0.06	-1.1 Scores on a scale Standard Error 0.06	—
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, n=359, 368	-1.5 Scores on a scale Standard Error 0.06	-1.1 Scores on a scale Standard Error 0.06	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT Population. Only those participants at risk for CP at the specified visit were analyzed.

The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS \>=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=369 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Events of Clinical Progression (CP) of BPH Year 1, n=369, 373	48 Events	94 Events	—
Number of Events of Clinical Progression (CP) of BPH Year 2, n=276, 251	17 Events	14 Events	—

SECONDARY outcome

Timeframe: Up to Month 24

Population: ITT Population

CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS \>=3 points from Baseline \[Visit 2\]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components ("Tied for first component"), and the number of participants with multiple first-occurring components were summarized by treatment group.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=369 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Participants with CP of BPH, n=369, 373	65 Participants	108 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH BPH symptom progression, n=65, 108	59 Participants	97 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH BPH-related AUR, n=65, 108	2 Participants	4 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH BPH-related incontinence, n=65, 108	4 Participants	3 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Recurrent BPH-related UTI, n=65, 108	0 Participants	4 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH BPH-related renal insufficiency, n=65, 108	0 Participants	0 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Tied for first component, n=65, 108	0 Participants	0 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Multiple components (2 components), n=65, 108	4 Participants	9 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Multiple components (3 components), n=65, 108	0 Participants	1 Participants	—
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Multiple components (>=4 components), n=65, 108	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to Month 24

Population: ITT Population

BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate \[TURP\], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=369 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with >=3 surgeries	0 Participants	0 Participants	—
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with any BPH-related surgery	6 Participants	3 Participants	—
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with cystoscopy	5 Participants	1 Participants	—
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with TURP	2 Participants	1 Participants	—
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with prostatectomy	0 Participants	1 Participants	—
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Participants with 2 surgeries	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.

The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: "Overall, how satisfied are you with the treatment and its effect on your urinary problems?" There were seven possible responses, including: "very satisfied," "satisfied," "somewhat satisfied," neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied." Response categories were created by grouping together "very satisfied," "satisfied," and "somewhat satisfied" responses into the category of "Any Satisfaction (AS)," and separately grouping "neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied" responses into the category of "Neutral or Any Dissatisfaction (N/AD)." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=364 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Baseline, Any Satisfaction, n=315, 328	119 Participants	122 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Baseline, Neutral/Any Dissatisfaction, n=315, 328	196 Participants	206 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, Any Satisfaction, n=358, 349	272 Participants	209 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, Neutral/Any Dissatisfaction, n=358, 349	86 Participants	140 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, Any Satisfaction, n= 359, 359	300 Participants	265 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, Neutral/Any Dissatisfaction, n=359, 359	59 Participants	94 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, Any Satisfaction, n=359, 361	301 Participants	285 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, Neutral /Any Dissatisfaction, n=359, 361	58 Participants	76 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, Any Satisfaction, n=359, 361	304 Participants	293 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, Neutral/Any Dissatisfaction, n= 359, 361	55 Participants	68 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, Any Satisfaction, n=359, 363	311 Participants	305 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, Neutral/Any Dissatisfaction, n=359, 363	48 Participants	58 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, Any Satisfaction, n=359, 364	311 Participants	299 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, Neutral/Any Dissatisfaction, n=359, 364	48 Participants	65 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, Any Satisfaction, n=359, 364	305 Participants	298 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, Neutral/Any Dissatisfaction, n=359, 364	54 Participants	66 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, Any Satisfaction, n=359, 364	310 Participants	300 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, Neutral/Any Dissatisfaction, n=359, 364	49 Participants	64 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, Any Satisfaction, n=359, 364	312 Participants	312 Participants	—
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, Neutral/Any Dissatisfaction, n=359, 364	47 Participants	52 Participants	—

SECONDARY outcome

Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.

The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: "Would you ask your doctor for the treatment you received in this study?" There were three possible responses, including: "Yes," "No," and "Not sure." Response categories included "Yes" and "No or Not Sure," created by grouping together "No" and "Not sure." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=359 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=364 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, Yes, n=359, 360	232 Participants	227 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, Yes, n=359, 361	238 Participants	231 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Baseline, Yes, n=315, 328	109 Participants	103 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Baseline, No or Not Sure, n=315, 328	206 Participants	225 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, Yes, n=358, 347	224 Participants	166 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 1, No or Not Sure, n=358, 347	134 Participants	181 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, Yes, n=359, 357	232 Participants	207 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 3, No or Not Sure, n=359, 357	127 Participants	150 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 6, No or Not Sure, n=359, 360	127 Participants	133 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 9, No or Not Sure, n=359, 361	121 Participants	130 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, Yes, n=359, 363	240 Participants	229 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 12, No or Not Sure, n=359, 363	119 Participants	134 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, Yes, n=359, 364	246 Participants	239 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 15, No or Not Sure, n=359, 364	113 Participants	125 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, Yes, n=359, 364	235 Participants	236 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 18, No or Not Sure, n=359, 364	124 Participants	128 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, Yes, n=359, 364	249 Participants	234 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 21, No or Not Sure, n=359, 364	110 Participants	130 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, Yes, n=359, 364	243 Participants	236 Participants	—
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Month 24, No or Not Sure, n=359, 364	116 Participants	128 Participants	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date

Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=368 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=229 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Exposure to Study Drug	639.8 days Standard Deviation 215.49	566.3 days Standard Deviation 195.13	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT Population

A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of \>=5%) and SAEs.

Outcome measures

Outcome measures
Measure	Dutasteride Plus Tamsulosin n=369 Participants Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 Participants All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).	Watchful Waiting Escalated=Yes n=229 Participants All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization Any AE	190 Participants	119 Participants	95 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization Any SAE	38 Participants	25 Participants	19 Participants

Adverse Events

Dutasteride Plus Tamsulosin

Serious events: 38 serious events

Other events: 43 other events

Deaths: 0 deaths

Watchful Waiting All: Escalated Yes and No

Serious events: 25 serious events

Other events: 13 other events

Deaths: 0 deaths

Watchful Waiting Escalated=Yes

Serious events: 19 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dutasteride Plus Tamsulosin n=369 participants at risk Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.	Watchful Waiting All: Escalated Yes and No n=373 participants at risk All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.	Watchful Waiting Escalated=Yes n=229 participants at risk All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Reproductive system and breast disorders Erectile dysfunction	8.4% 31/369 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.	1.1% 4/373 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.	1.3% 3/229 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.
Reproductive system and breast disorders Retrograde ejaculation	5.1% 19/369 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.	2.7% 10/373 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.	4.4% 10/229 • Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years). SAEs and non-serious AEs are reported for members of the ITT Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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