A Phase 4 interventional study of Dutasteride plus tamsulosin and tamsulosin in Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed at 80 sites in 8 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH).
Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.
After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
This will be a European, multicentre, randomised, open-label, parallel group study. The aim of the study is to investigate whether Dutasteride plus Tamulson treatment with lifestyle advice is more effective than watchful waiting treatment plus lifestyle advice plus step-up therapy with tamsulosin for improvement of symptoms and Acte Urinary Retention (AUR) and BPH-related prostatic surgery, in older men (≥50 yrs), with moderate symptoms of BPH (IPSS 8-19), enlarged prostates (≥30cc) and Prostate Specific Antigen (PSA) ≥1.5ng/mL.
Data from all participating centres will be pooled prior to analysis. Investigative centres will be pooled a priori into clusters based on geographic location; these clusters may be used in analyses to adjust for site effects. Clusters will be defined once all investigative centres have been identified and randomisation has been completed.
Subjects will be screened for inclusion into the study and eligible subjects will be randomised by investigative centre. Subjects will be allocated to one of two treatment groups, according to a pre-determined randomisation schedule (in a 1:1 ratio):
Approximately 760, treatment naive men with symptomatic BPH will be randomised into the study in order to achieve at least 592 evaluable subjects. 380 into the Dutasteride plus tamsulosin with lifestyle advice arm and 380 into the watchful waiting plus lifestyle advice arm.
Treatment naïve is defined as a man that has recently been diagnoses with BPH whom has received no prescribed therapeutic treatment. For example, medicines such as 5 α-reductase inhibitors (5-ARIs) or invasive procedures such as transurethral resection of the prostate (TURP) prescribed to directly treat the BPH symptoms are considered therapeutic treatments. As per the entry criteria, phytotherapy is allowed unless it was performed less than two weeks prior to the screening visit.
The anticipated recruitment period will be approximately 6 months. The study will be conducted in approximately 8 countries within Europe.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 742 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Note: If total serum PSA is >4 ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further Digital rectal examination (DRE), review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice
Exclusion Criteria:
Excluded medication and therapies Current or any prior use of the following prohibited medications
Current use of:
Have a known (immediate or delayed) hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GlaxoSmithKline contraindicates their participation.
Recent Medical Procedures
Medical history
Dutasteride plus tamsulosin arm + lifestyle advice
Drug: Dutasteride plus tamsulosin
Watchful waiting with escalation to tamsulosin
Drug: tamsulosin
Take 1 capsule daily
Take 1 capsule daily when escalation criteria met
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
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.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
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
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).
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
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
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.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
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
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.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Number of Events of Clinical Progression (CP) of BPH
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.
Time frame: Up to 2 years
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH
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.
Time frame: Up to Month 24
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
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.
Time frame: Up to Month 24
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
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.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
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
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.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Exposure to Study Drug
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.
Time frame: Up to 2 years
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization
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.
Time frame: Up to 2 years
| Milestone | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Started | 369 | 373 |
| Completed | 292 | 300 |
| Not completed | 77 | 73 |
| Withdrew: Adverse event | 28 | 13 |
| Withdrew: Lack of efficacy | 7 | 5 |
| Withdrew: Protocol violation | 1 | 7 |
| Withdrew: Lost to follow-up | 7 | 9 |
| Withdrew: Physician decision | 6 | 11 |
| Withdrew: Withdrawal by subject | 28 | 28 |
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.
| Scores on a scale | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Month 1, n=358, 367 | -3.2 ± 0.21 | -0.9 ± 0.20 |
| Month 3, n=359, 368 | -4.5 ± 0.22 | -2.4 ± 0.22 |
| Month 6, n=359, 368 | -4.6 ± 0.23 | -3.2 ± 0.22 |
| Month 9, n=359, 368 | -5.1 ± 0.22 | -3.6 ± 0.22 |
| Month 12, n=359, 368 | -5.2 ± 0.23 | -3.6 ± 0.23 |
| Month 15, n=359, 368 | -5.2 ± 0.25 | -3.6 ± 0.24 |
| Month 18, n=359, 368 | -5.1 ± 0.25 | -3.3 ± 0.25 |
| Month 21, n=359, 368 | -5.5 ± 0.25 | -3.6 ± 0.24 |
| Month 24, n=359, 368 | -5.4 ± 0.25 | -3.6 ± 0.25 |
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).
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Month 1, >=2 points, n=358, 367 | 225 | 149 |
| Month 1, >=3 points, n=358, 367 | 182 | 90 |
| Month 1, >=25 percent, n=358, 367 | 161 | 76 |
| Month 3, >=2 points, n=359, 368 | 277 | 221 |
| Month 3, >=3 points, n=359, 368 | 233 | 172 |
| Month 3, >=25 percent, n= 359, 368 | 218 | 150 |
| Month 6, >=2 points, n=359, 368 | 277 | 250 |
| Month 6, >=3 points, n=359, 368 | 245 | 208 |
| Month 6, >=25 percent, n=359, 368 | 229 | 189 |
| Month 9, >=2 points, n=359, 368 | 286 | 276 |
| Month 9, >=3 points, n=359, 368 | 257 | 222 |
| Month 9, >=25 percent, n=359, 368 | 247 | 207 |
| Month 12, >=2 points, n=359, 368 | 291 | 273 |
| Month 12, >=3 points, n=359, 368 | 261 | 229 |
| Month 12, >=25 percent, n= 359, 368 | 249 | 214 |
| Month 15, >=2 points, n=359, 368 | 289 | 275 |
| Month 15, >=3 points, n=359, 368 | 259 | 243 |
| Month 15, >=25 percent, n=359, 368 | 245 | 231 |
| Month 18, >=2 points, n=359, 368 | 288 | 268 |
| Month 18, >=3 points, n=359, 368 | 262 | 229 |
| Month 18, >=25 percent, 359, 368 | 245 | 212 |
| Month 21, >=2 points, n=359, 368 | 292 | 274 |
| Month 21, >=3 points, n=359, 368 | 267 | 237 |
| Month 21, >=25 percent, n= 359, 368 | 253 | 224 |
| Month 24, >=2 points, n=359, 368 | 295 | 279 |
| Month 24, >=3points, n=359, 368 | 277 | 234 |
| Month 24, >=25 percent, n= 359, 368 | 261 | 221 |
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.
| Scores on a scale | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Month 1, n=357, 366 | -1.3 ± 0.11 | -0.4 ± 0.11 |
| Month 3, n=359, 368 | -1.8 ± 0.11 | -1.0 ± 0.11 |
| Month 6, n=359, 368 | -1.9 ± 0.11 | -1.3 ± 0.11 |
| Month 9, n=359, 368 | -2.1 ± 0.11 | -1.5 ± 0.11 |
| Month 12, n=359, 368 | -2.1 ± 0.12 | -1.5 ± 0.12 |
| Month 15, n=359, 368 | -2.2 ± 0.12 | -1.5 ± 0.12 |
| Month 18, n=359, 368 | -2.2 ± 0.12 | -1.4 ± 0.12 |
| Month 21, n=359, 368 | -2.4 ± 0.12 | -1.6 ± 0.12 |
| Month 24, n=359, 368 | -2.4 ± 0.12 | -1.6 ± 0.12 |
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.
| Scores on a scale | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Month 1, n=358, 367 | -0.8 ± 0.06 | -0.3 ± 0.05 |
| Month 3, n=359, 368 | -1.1 ± 0.06 | -0.7 ± 0.06 |
| Month 6, n=359, 368 | -1.2 ± 0.06 | -0.9 ± 0.06 |
| Month 9, n=359, 368 | -1.3 ± 0.06 | -1.0 ± 0.06 |
| Month 12, n=359, 368 | -1.3 ± 0.06 | -1.1 ± 0.06 |
| Month 15, n=359, 368 | -1.4 ± 0.06 | -1.1 ± 0.06 |
| Month 18, n=359, 368 | -1.4 ± 0.06 | -1.1 ± 0.06 |
| Month 21, n=359, 368 | -1.5 ± 0.06 | -1.1 ± 0.06 |
| Month 24, n=359, 368 | -1.5 ± 0.06 | -1.1 ± 0.06 |
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.
| Events | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Year 1, n=369, 373 | 48 | 94 |
| Year 2, n=276, 251 | 17 | 14 |
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.
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Participants with CP of BPH, n=369, 373 | 65 | 108 |
| BPH symptom progression, n=65, 108 | 59 | 97 |
| BPH-related AUR, n=65, 108 | 2 | 4 |
| BPH-related incontinence, n=65, 108 | 4 | 3 |
| Recurrent BPH-related UTI, n=65, 108 | 0 | 4 |
| BPH-related renal insufficiency, n=65, 108 | 0 | 0 |
| Tied for first component, n=65, 108 | 0 | 0 |
| Multiple components (2 components), n=65, 108 | 4 | 9 |
| Multiple components (3 components), n=65, 108 | 0 | 1 |
| Multiple components (>=4 components), n=65, 108 | 0 | 1 |
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.
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Participants with any BPH-related surgery | 6 | 3 |
| Participants with cystoscopy | 5 | 1 |
| Participants with TURP | 2 | 1 |
| Participants with prostatectomy | 0 | 1 |
| Participants with 2 surgeries | 1 | 0 |
| Participants with >=3 surgeries | 0 | 0 |
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.
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Baseline, Any Satisfaction, n=315, 328 | 119 | 122 |
| Baseline, Neutral/Any Dissatisfaction, n=315, 328 | 196 | 206 |
| Month 1, Any Satisfaction, n=358, 349 | 272 | 209 |
| Month 1, Neutral/Any Dissatisfaction, n=358, 349 | 86 | 140 |
| Month 3, Any Satisfaction, n= 359, 359 | 300 | 265 |
| Month 3, Neutral/Any Dissatisfaction, n=359, 359 | 59 | 94 |
| Month 6, Any Satisfaction, n=359, 361 | 301 | 285 |
| Month 6, Neutral /Any Dissatisfaction, n=359, 361 | 58 | 76 |
| Month 9, Any Satisfaction, n=359, 361 | 304 | 293 |
| Month 9, Neutral/Any Dissatisfaction, n= 359, 361 | 55 | 68 |
| Month 12, Any Satisfaction, n=359, 363 | 311 | 305 |
| Month 12, Neutral/Any Dissatisfaction, n=359, 363 | 48 | 58 |
| Month 15, Any Satisfaction, n=359, 364 | 311 | 299 |
| Month 15, Neutral/Any Dissatisfaction, n=359, 364 | 48 | 65 |
| Month 18, Any Satisfaction, n=359, 364 | 305 | 298 |
| Month 18, Neutral/Any Dissatisfaction, n=359, 364 | 54 | 66 |
| Month 21, Any Satisfaction, n=359, 364 | 310 | 300 |
| Month 21, Neutral/Any Dissatisfaction, n=359, 364 | 49 | 64 |
| Month 24, Any Satisfaction, n=359, 364 | 312 | 312 |
| Month 24, Neutral/Any Dissatisfaction, n=359, 364 | 47 | 52 |
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.
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No |
|---|---|---|
| Baseline, Yes, n=315, 328 | 109 | 103 |
| Baseline, No or Not Sure, n=315, 328 | 206 | 225 |
| Month 1, Yes, n=358, 347 | 224 | 166 |
| Month 1, No or Not Sure, n=358, 347 | 134 | 181 |
| Month 3, Yes, n=359, 357 | 232 | 207 |
| Month 3, No or Not Sure, n=359, 357 | 127 | 150 |
| Month 6, Yes, n=359, 360 | 232 | 227 |
| Month 6, No or Not Sure, n=359, 360 | 127 | 133 |
| Month 9, Yes, n=359, 361 | 238 | 231 |
| Month 9, No or Not Sure, n=359, 361 | 121 | 130 |
| Month 12, Yes, n=359, 363 | 240 | 229 |
| Month 12, No or Not Sure, n=359, 363 | 119 | 134 |
| Month 15, Yes, n=359, 364 | 246 | 239 |
| Month 15, No or Not Sure, n=359, 364 | 113 | 125 |
| Month 18, Yes, n=359, 364 | 235 | 236 |
| Month 18, No or Not Sure, n=359, 364 | 124 | 128 |
| Month 21, Yes, n=359, 364 | 249 | 234 |
| Month 21, No or Not Sure, n=359, 364 | 110 | 130 |
| Month 24, Yes, n=359, 364 | 243 | 236 |
| Month 24, No or Not Sure, n=359, 364 | 116 | 128 |
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.
| days | Dutasteride Plus Tamsulosin | Watchful Waiting Escalated=Yes |
|---|---|---|
| Exposure to Study Drug | 639.8 ± 215.49 | 566.3 ± 195.13 |
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.
| Participants | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Watchful Waiting Escalated=Yes |
|---|---|---|---|
| Any AE | 190 | 119 | 95 |
| Any SAE | 38 | 25 | 19 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | — | 38/369 (10.3%) | 43/369 (11.7%) |
| Watchful Waiting All: Escalated Yes and No | — | 25/373 (6.7%) | 13/373 (3.5%) |
| Watchful Waiting Escalated=Yes | — | 19/229 (8.3%) | 12/229 (5.2%) |
| Event | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Watchful Waiting Escalated=Yes |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 4/369 | 2/373 | 2/229 |
| Respiratory tract infectionInfections and infestations | 1/369 | 2/373 | 2/229 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/369 | 2/373 | 2/229 |
| CellulitisInfections and infestations | 2/369 | 0/373 | 0/229 |
| Inguinal herniaGastrointestinal disorders | 2/369 | 1/373 | 0/229 |
| PresyncopeNervous system disorders | 2/369 | 0/373 | 0/229 |
| DiverticulitisInfections and infestations | 0/369 | 2/373 | 1/229 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/369 | 2/373 | 1/229 |
| ProstatitisReproductive system and breast disorders | 1/369 | 2/373 | 1/229 |
| Cardiac failureCardiac disorders | 1/369 | 1/373 | 1/229 |
| Event | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Watchful Waiting Escalated=Yes |
|---|---|---|---|
| Erectile dysfunctionReproductive system and breast disorders | 31/369 | 4/373 | 3/229 |
| Retrograde ejaculationReproductive system and breast disorders | 19/369 | 10/373 | 10/229 |
| Age, Continuous(Years) | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Total |
|---|---|---|---|
| Mean | 66.3 ± 7.78 | 66.2 ± 7.34 | 66.2 ± 7.56 |
| Sex: Female, Male(Participants) | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 369 | 373 | 742 |
| Race/Ethnicity, Customized(Participants) | Dutasteride Plus Tamsulosin | Watchful Waiting All: Escalated Yes and No | Total |
|---|---|---|---|
| White - White/Caucasian/European Heritage | 357 | 363 | 720 |
| White - Arabic/North African Heritage | 4 | 2 | 6 |
| African American/African Heritage | 0 | 2 | 2 |
| Mixed Race | 0 | 1 | 1 |
| Missing | 8 | 5 | 13 |
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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