An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
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Purpose
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.
| Condition |
|---|
|
Benign Prostatic Hyperplasia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL |
| Estimated Enrollment: | 855 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Benign Prostatic Hyperplasia male paitents
Inclusion Criteria:
- Males, age ≧ 50 years
- Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
- IPSS score ≧ 8 points and prostate volume ≧ 30 mL
- Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
- Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
- Dutasteride combination therapy will be allowed by investigator's prescription
- Ability to understand and willingly provide written informed consent
Exclusion Criteria:
- History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
- With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
- Use of finasteride within 6 months of screening visit
- Use of dutasteride within 12 months of screening visit
Contacts and Locations| Taiwan | |
| Taipei Medical University - WanFang Hospital | |
| Taipei, Taiwan | |
| Principal Investigator: | Liang-Ming Lee | Taipei Medical University WanFang Hospital |
More Information
No publications provided
| Responsible Party: | Liang-Ming Lee, Superintendent Office, Wanfang Hospital |
| ClinicalTrials.gov Identifier: | NCT01351987 History of Changes |
| Other Study ID Numbers: | 100006 |
| Study First Received: | May 10, 2011 |
| Last Updated: | May 10, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Taipei Medical University WanFang Hospital:
|
Benign Prostatic Hyperplasia |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes Adrenergic alpha-Antagonists Dutasteride Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs 5-alpha Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013