An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
To analyze the change in International Prostate Symptom Score (IPSS) and serum
 prostate-specific antigen (PSA) level from baseline.
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.
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