Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tamsulosin
Intervention 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.
Intervention MeSH terms: Tamsulosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia; Dutasteride; Tamsulosin

Summary:

      This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg),
      administered once daily for one year in combination with Tamsulosin (0.4mg), administered
      once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as
      needed basis, on the improvement of symptoms and clinical outcome in men with moderate to
      severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9
      months), the subject will be counseled on withdrawal of Tamsulosin. After randomization,
      study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic
      visits)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male ≥50 yrs

          2. Diagnosed BPH by medical history and physical examination, including a digital rectal
             examination

          3. International Prostate Symptom Score ≥12 points at Screening

          4. Prostate volume ≥30cc (by transrectal ultrasonography; TRUS)

          5. Total serum Prostate Specific Antigen ≥1.5 ng/mL at Screening

          6. Maximum flow rate ≥5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at
             Screening (based on two voids)

          7. Able to give written informed consent and comply with study procedures

          8. Literate in English language with the ability to read, comprehend, and record
             information on the IPSS, BII, and PPSM questionnaires

          9. Able to swallow and retain oral medication

         10. Able to participate for study duration

        Exclusion Criteria:

          1. 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).

          2. History or evidence of prostate cancer

          3. Previous prostatic surgery or other invasive procedures to treat BPH

          4. 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.

          5. History of AUR within 3 months prior to Screening

          6. Post-void residual volume >250mL (suprapubic ultrasound) at Screening

          7. Any causes other than BPH, which may in the judgment of the investigator, result in
             urinary symptoms or changes in flow rate

          8. History of breast cancer or clinical breast examination finding of unclear origin or
             suggestive of malignancy

          9. 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.

         10. Concurrent use of anabolic steroids

         11. Use of phytotherapy for BPH within 2 weeks of Screening

         12. Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening

         13. Use of any alpha-adrenoreceptor agonists, anticholinergics or cholinergics within 48
             hours prior to all uroflowmetry assessments.

         14. Hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase
             inhibitor, or other chemically-related drugs.

         15. Concurrent use of drugs known or thought to interaction with Tamsulosin.

         16. 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.