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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ClinicalTrials.gov Identifier: NCT01351987
Verified May 2011 by Taipei Medical University WanFang Hospital. Recruitment status was: Active, not recruiting
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.
Condition or disease
Benign Prostatic Hyperplasia
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.
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Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Benign Prostatic Hyperplasia male paitents
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
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