Overview

This trial is active, not recruiting.

Condition benign prostate hyperplasia
Treatments tamsulosin, finasteride, placebo
Phase phase 4
Sponsor Seoul National University Hospital
Collaborator Astellas Pharma Korea, Inc.
Start date February 2012
End date February 2017
Trial size 545 participants
Trial identifier NCT01736033, TMS1011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
tamsulosin Harnal D (brand name in Asia)
1 tablet(0.2mg) orally q.d.
placebo Placebo
1 tablet(0.2mg) orally q.d.
(Active Comparator)
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
tamsulosin Harnal D (brand name in Asia)
1 tablet(0.2mg) orally q.d.
finasteride Proscar
1 tablet(5mg) orally q.d.

Primary Outcomes

Measure
Clinical Progression
time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years

Secondary Outcomes

Measure
International Prostate Symptom Score(IPSS)
time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years
International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
time frame: every 6 months up to 4 years
Uroflowmetry
time frame: every 6 months up to 4 years
Prostate volume
time frame: every 1 year up to 4 years
Global Response Assessment(GRA)
time frame: every 1 year up to 4 years
PSA level
time frame: every 1 year up to 4 years
Blood Chemistry
time frame: every 1 year up to 4 years
Adverse Events
time frame: every visit up to 4 years
Physical examination
time frame: every 1 year up to 4 years
Male Sexual Health Questionnaire
time frame: every 6 months up to 4 years

Eligibility Criteria

Male participants at least 50 years old.

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

Additional Information

Official title A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH
Principal investigator Soo Woong Kim, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.