Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

Inclusion criteria

• A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
• males, aged ≥50 years
• clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
• International Prostate Symptom Score (IPSS) ≥12 points at Screening
• prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
• total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
• maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
• willing and able to give written informed consent and comply with study procedures
• fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
• able to swallow and retain oral medication
• willing and able to participate in the study for the full 4 years.

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

• total serum PSA >10.0ng/mL at Screening
• history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.

• previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
• history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
• history of AUR within 3 months prior to Screening Visit.
• post-void residual volume >250mL (suprapubic ultrasound) at Screening.
• any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
• history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
• use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
• concurrent use of anabolic steroids
• use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
• use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.

Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.

• use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) 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