Benign Prostatic HyperplasiaPhase 4NCT00701779
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
A Phase 4 study testing Tamsulosin in people with Benign Prostatic Hyperplasia, run by Siami, Paul F., M.D. at 1 site in United States.
Trial summary
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥50 yrs
- Diagnosed BPH by medical history and physical examination, including a digital rectal examination
- International Prostate Symptom Score ≥12 points at Screening
- Prostate volume ≥30cc (by transrectal ultrasonography; TRUS)
- Total serum Prostate Specific Antigen ≥1.5 ng/mL at Screening
- Maximum flow rate ≥5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
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- Able to give written informed consent and comply with study procedures
- Literate in English language with the ability to read, comprehend, and record information on the IPSS, BII, and PPSM questionnaires
- Able to swallow and retain oral medication
- Able to participate for study duration
Who cannot join
- Total serum PSA >10.0 ng/mL at Screening. Patients with total serum PSA >10.0 ng/mL may be acceptable for inclusion if the PSA elevation is thought to be due to BPH and not prostate cancer (by TRUS and biopsies showing no evidence of prostate cancer).
- History or evidence of prostate cancer
- Previous prostatic surgery or other invasive procedures to treat BPH
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Screening. Catheterization (<10F) is acceptable with no time restriction.
- History of AUR within 3 months prior to Screening
- Post-void residual volume >250mL (suprapubic ultrasound) at Screening
Show all 21Show fewer
- Any causes other than BPH, which may in the judgment of the investigator, result in urinary symptoms or changes in flow rate
- History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy
- Use of 5 alpha-reductase inhibitor, any drugs with antiandrogenic properties, or drugs noted for gynecomastia effects, within past 6 months and throughout the study. Previous use of AVODART within 12 months of the baseline or historical TRUS. Chronic use of Metronidazole is prohibited.
- Concurrent use of anabolic steroids
- Use of phytotherapy for BPH within 2 weeks of Screening
- Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening
- Use of any alpha-adrenoreceptor agonists, anticholinergics or cholinergics within 48 hours prior to all uroflowmetry assessments.
- Hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
- Concurrent use of drugs known or thought to interaction with Tamsulosin.
- History of hepatic impairment, abnormal liver function at Screening, History of renal insufficiency, serum creatinine >1.5 times the upper limit
- 18. history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 2 years.
- 19. History of any illness the investigator might confound the results of the study or poses additional risk to the patient.
- 20. Any unstable, serious co-existing medical condition(s) 21. History of postural hypotension, dizziness, vertigo, or any other signs and symptoms of orthostasis.
- 22. History of 'first dose' hypotensive episode on initiation of alpha-l-adrenoreceptor antagonist therapy.
- 23. History of unsuccessful treatment with finasteride or Dutasteride 24. History or current drug or alcohol abuse within the previous 12 months. 25. Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding Screening and/or during the course of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Institute of Deaconess Clinic
Evansville, Indiana, 47713
About this study
Official title: Dutasteride (0.5mg) Once Daily for One Year and Tamsulosin (0.4mg) Once Daily for 3 Months, Followed by Counseling on Flex Dose Tamsulosin as Needed on Improvement of Symptoms and Outcome in Men With Moderate to Severe Symptomatic BPH
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
Read the detailed description
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin.
A recently published, landmark study (MTOPS - Medical Therapy of Prostatic Symptoms), co-sponsored by the National Institute of Health and the National Institute of Diabetes, Digestive and Kidney Diseases (NIH-NIDDK), demonstrated that, in selected patients, combination therapy with Doxazosin and Finasteride provided additive symptomatic improvements, reduced the risk of acute urinary retention (AUR) and surgical intervention, and was a more effective treatment for reduction in the overall risk of BPH clinical progression.
The aim of this proposed combination study, in a population of patients at high risk of BPH clinical progression, is to investigate whether combination therapy with Dutasteride and Tamsulosin with the subsequent withdrawal of Tamsulosin can maintain superior symptom improvement. At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. We hypothesize that patients may start with a combination of Dutasteride and Tamsulosin and eventually may be able to eliminate the use of Tamsulosin and maintain acceptable urinary symptoms on Dutasteride alone.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin
- Keywords
- Benign Prostatic Hyperplasia, Dutasteride, Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
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.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Experimental | 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. Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score
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
Measured: 12 months
Peak Flow Rate (QMax)
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.
Measured: 12 months
Benign Prostate Hyperplasia Impact Index
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:
- Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)
- Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)
- Overall, how bothersome has any trouble with urination been during the past month? (0-3)
- 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.
Measured: 12 months
Post-void Residual Volume
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.
Measured: 12 months
Prostate Specific Antigen
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.
Measured: 12 months
Secondary outcomes (4)
Health Outcome Measures
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
Measured: 13 months
Safety and Tolerability
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.
Measured: 13 months
Economic Impact
Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.
Measured: 13 months
Number of Participants With a Reduction of AUR and BPH-related Surgery
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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siami, Paul F., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Paul F. Siami, MD, Siami, Paul F., M.D.
- Investigators
- Paul F Siami, MD, Principal investigator, Deaconess Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701779
- Sponsor's protocol ID
- Siami104907
- Status last verified
- Nov 2018
- First submitted
- 17 Jun 2008
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutasteride (0.5mg) Once Daily for One Year and Tamsulosin (0.4mg) Once Daily for 3 Months, Followed by Counseling on Flex Dose Tamsulosin as Needed on Improvement of Symptoms and Outcome in Men With Moderate to Severe Symptomatic BPH
- ClinicalTrials.gov ID
- NCT00701779
- Acronym / sponsor ID
- Siami104907
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, Dutasteride, Tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Siami, Paul F., M.D.University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
Detailed description
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin.
A recently published, landmark study (MTOPS - Medical Therapy of Prostatic Symptoms), co-sponsored by the National Institute of Health and the National Institute of Diabetes, Digestive and Kidney Diseases (NIH-NIDDK), demonstrated that, in selected patients, combination therapy with Doxazosin and Finasteride provided additive symptomatic improvements, reduced the risk of acute urinary retention (AUR) and surgical intervention, and was a more effective treatment for reduction in the overall risk of BPH clinical progression.
The aim of this proposed combination study, in a population of patients at high risk of BPH clinical progression, is to investigate whether combination therapy with Dutasteride and Tamsulosin with the subsequent withdrawal of Tamsulosin can maintain superior symptom improvement. At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. We hypothesize that patients may start with a combination of Dutasteride and Tamsulosin and eventually may be able to eliminate the use of Tamsulosin and maintain acceptable urinary symptoms on Dutasteride alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | Experimental | Drug: TamsulosinDutasteride 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male ≥50 yrs
- Diagnosed BPH by medical history and physical examination, including a digital rectal examination
- International Prostate Symptom Score ≥12 points at Screening
- Prostate volume ≥30cc (by transrectal ultrasonography; TRUS)
- Total serum Prostate Specific Antigen ≥1.5 ng/mL at Screening
Key exclusion criteria (21 listed)
- Total serum PSA >10.0 ng/mL at Screening. Patients with total serum PSA >10.0 ng/mL may be acceptable for inclusion if the PSA elevation is thought to be due to BPH and not prostate cancer (by TRUS and biopsies showing no evidence of prostate cancer).
- History or evidence of prostate cancer
- Previous prostatic surgery or other invasive procedures to treat BPH
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Screening. Catheterization (<10F) is acceptable with no time restriction.
- History of AUR within 3 months prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: FlomaxDutasteride 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. | Drug | Dutasteride |
Primary outcome
International Prostate Symptom Score
Time frame: 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
Peak Flow Rate (QMax)
Time frame: 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.
Benign Prostate Hyperplasia Impact Index
Time frame: 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.
Post-void Residual Volume
Time frame: 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.
Prostate Specific Antigen
Time frame: 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.
4 secondary outcomes
Health Outcome Measures
Time frame: 13 months
Safety and Tolerability
Time frame: 13 months
Economic Impact
Time frame: 13 months
Number of Participants With a Reduction of AUR and BPH-related Surgery
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Siami, MD principal investigator
Deaconess Clinic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin in people with Benign Prostatic Hyperplasia, run by Siami, Paul F., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.