Intervention: Tamsulosin
Trial phase: Phase 4
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: 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.

Tamsulosin: 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.
Eligibility criteria:
Inclusion Criteria:

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)
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

Exclusion Criteria:

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
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.