MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.

Subproject MCS-2: alpha-blocker naïve subjects

Subproject MCS-3: subjects responding poorly to alpha-blocker

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Criteria

Inclusion criteria for subproject MCS-2

• Age ≧ 40 years old.

• Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.

• PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.

• No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

• AST/ALT≦3X UNL.

• creatinine≦3X UNL.

• Subjects who sign the informed consent form.

Exclusion criteria

• Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

• Have been treated with pelvis irradiation or pelvic surgery.

• Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.

• Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.

• Active infection or inflammation.

• Considered ineligible by the investigators.

Inclusion criteria for subproject MCS-3

• Age≧40 years old.

• The alpha-blocker dosage used should be as high as subjects can tolerate.

• No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

• PSA≦10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory > 12 weeks before screening, if PSA is≧4 ng/ml to rule out prostate cancer.

• AST/ALT≦3X UNL.

• Creatinine≦3X UNL.

• Subjects who sign the informed consent form.

Exclusion criteria

• Subjects' LUTS are not BPH-related but associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

• Subjects who have been treated with pelvis irradiation or pelvic surgery.

• PSA > 10.0 ng/ml, abnormal DRE of the prostate or any suspicion of prostate malignancy. However, those who have a negative prostate biopsy are allowed.

• Active infection or inflammation.

• Considered ineligible by the investigators.