Trial Outcomes & Findings for Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia (NCT NCT00701779)

Results Overview

Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom. Total range is from 0-35. The scores are evaluated as such: 0-7: Mild 8-19: Moderate 20-35: Severe

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

12 months

Results posted on

2018-11-02

Participant Flow

Medical Clinic

The population of subjects will be the 'Intent-toTreat' population.

Participant milestones

Participant milestones
Measure	Dutasteride Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Overall Study STARTED	63
Overall Study 3 Month	60
Overall Study 6 Month	58
Overall Study 9 Month	56
Overall Study 12 Month	54
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Dutasteride Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Age, Customized	66.63 years STANDARD_DEVIATION 8.50 • n=93 Participants
Sex/Gender, Customized Male	54 participants n=93 Participants
International Prostate Symptom Score (IPSS)	19.80 units on a scale STANDARD_DEVIATION 5.86 • n=93 Participants
Peak Flow Rate	10.14 ml/sec STANDARD_DEVIATION 2.64 • n=93 Participants
Prostate Specific Antigen	4.70 ng/mL STANDARD_DEVIATION 3.01 • n=93 Participants
Prostate Volume	57.61 cc STANDARD_DEVIATION 22.83 • n=93 Participants
Post-Void Residual Volume	82.33 ml STANDARD_DEVIATION 58.36 • n=93 Participants
Benign Prostatic Hyperplasia Impact Index (BII)	6.31 units on a scale STANDARD_DEVIATION 3.11 • n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom. Total range is from 0-35. The scores are evaluated as such: 0-7: Mild 8-19: Moderate 20-35: Severe

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
International Prostate Symptom Score	11.31 units on a scale Standard Deviation 6.48

PRIMARY outcome

Timeframe: 12 months

Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Peak Flow Rate (QMax)	20.43 ml/sec Standard Deviation 38.68

PRIMARY outcome

Timeframe: 12 months

Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Benign Prostatic Hyperplasia Impact Index asked the following: 1. Over the past month, how much physical discomfort did any urinary problems cause you? (0-3) 2. Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3) 3. Overall, how bothersome has any trouble with urination been during the past month? (0-3) 4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Benign Prostate Hyperplasia Impact Index	3.28 units on a scale Standard Deviation 2.81

PRIMARY outcome

Timeframe: 12 months

Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Post-void Residual Volume	87.19 mL Standard Deviation 83.47

PRIMARY outcome

Timeframe: 12 months

Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Prostate Specific Antigen	1.91 ng/mL Standard Deviation 1.52

SECONDARY outcome

Timeframe: 13 months

Number of participants who are able to subsequently reduce or discontinue Tamsulosin usage after starting with combination therapy with Dutasteride and Tamsulosin while still maintaining the same degree of improvement in lower urinary tract symptoms

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Health Outcome Measures	31 Participants

SECONDARY outcome

Timeframe: 13 months

To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Safety and Tolerability	27 adverse events

SECONDARY outcome

Timeframe: 13 months

Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Economic Impact	643.99 US dollars Standard Deviation 306.91

SECONDARY outcome

Timeframe: 13 months

To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.

Outcome measures

Outcome measures
Measure	Dutasteride n=54 Participants Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Number of Participants With a Reduction of AUR and BPH-related Surgery	54 Participants

Adverse Events

Dutasteride

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dutasteride n=63 participants at risk Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.6% 1/63 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoarthritis worsening	1.6% 1/63 • Number of events 1
Cardiac disorders Chest Pain	4.8% 3/63 • Number of events 3
Respiratory, thoracic and mediastinal disorders Shortness of Breath	1.6% 1/63 • Number of events 1
Cardiac disorders Atrial Fibrillation	1.6% 1/63 • Number of events 1
Cardiac disorders Bradycardia	1.6% 1/63 • Number of events 1
Vascular disorders Cerebrovascular Accident	1.6% 1/63 • Number of events 1
Vascular disorders Deep Vein Thrombosis	1.6% 1/63 • Number of events 1
Vascular disorders Peripheral Vascular Disease	1.6% 1/63 • Number of events 1
Respiratory, thoracic and mediastinal disorders Acute Bronchitis	1.6% 1/63 • Number of events 1
Blood and lymphatic system disorders Pancytopenia	1.6% 1/63 • Number of events 1

Other adverse events

Other adverse events
Measure	Dutasteride n=63 participants at risk Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks. Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
General disorders Fatigue	4.8% 3/63 • Number of events 3
Gastrointestinal disorders Lower Abdominal Pain	6.3% 4/63 • Number of events 4
Musculoskeletal and connective tissue disorders Back Pain	6.3% 4/63 • Number of events 4
Respiratory, thoracic and mediastinal disorders Bronchitis	6.3% 4/63 • Number of events 5
Respiratory, thoracic and mediastinal disorders Cough	11.1% 7/63 • Number of events 7
Respiratory, thoracic and mediastinal disorders Sinus Infection	6.3% 4/63 • Number of events 4
Injury, poisoning and procedural complications Laceration	4.8% 3/63 • Number of events 3
Skin and subcutaneous tissue disorders Rash	6.3% 4/63 • Number of events 4
Reproductive system and breast disorders Retrograde Ejaculation	12.7% 8/63 • Number of events 9

Additional Information

Paul F. Siami, MD CPI

Deaconess Clinic, Inc.

Phone: 812-426-9576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place