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An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Taipei Medical University WanFang Hospital Identifier:
First received: May 10, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

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

Resource links provided by NLM:

Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 855
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Detailed Description:
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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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Please refer to this study by its identifier: NCT01351987

Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Liang-Ming Lee Taipei Medical University WanFang Hospital
  More Information

Responsible Party: Liang-Ming Lee, Superintendent Office, Wanfang Hospital Identifier: NCT01351987     History of Changes
Other Study ID Numbers: 100006
Study First Received: May 10, 2011
Last Updated: May 10, 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Adrenergic alpha-Antagonists
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents processed this record on April 28, 2017