Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients (ABSOLUTE)

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Benign Prostate Hyperplasia

Treatments: Drug: Placebo; Drug: Finasteride; Drug: Tamsulosin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01736033

TMS1011

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.

Full description

Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.

As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.

Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.

Enrollment: 545 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients aged over 50
• Clinically diagnosed benign prostate hyperplasia(BPH)
• 8 ≤ IPSS ≤ 30
• 4 ml/sec ≤ Q max ≤ 15 ml/sec
• minimum voided volume ≥ 125 ml
• Post voided residual volume ≤ 250
• Volunteer who singed on informed consent documents

Exclusion criteria

• Past history of surgical procedure experience related to BPH

• Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time

• Past history of taking alpha blocker within 2 weeks before screening

• Past history of acute urinary retention within 3 months before screening

• Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)

• Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)

• Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)

• Unstable and significant medical condition including below

  • Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
  • Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
  • Medically uncontrollable diabetes mellitus, peptic ulcer disease
  • Severe hepatic diseases
  • Past history of renal failure or renal disease (serum creatinine > 1.4mg/dl)
  • Condition expected serious adverse event due to the investigational drug

• Other conditions considered not eligible for the trial upon investigator's judgement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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545 participants in 2 patient groups, including a placebo group

Tamsulosin + Placebo

Placebo Comparator group

Description:

Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression

Treatment:

Drug: Tamsulosin

Drug: Placebo

Tamsulosin + Finasteride

Active Comparator group

Description:

Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression

Treatment:

Drug: Tamsulosin

Drug: Finasteride