mcs in treating lower urinary tract symptoms (luts) suggestive of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

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

for mcs-2 this is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, n=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either mcs 30 mg/day or placebo for 12 weeks. group a: mcs 30 mg/day for 12 weeks group b: placebo for 12 weeks subjects are limited to those who are currently not being treated medically for bph or luts with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. for each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study. for mcs-3 this is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, n=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either mcs 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks. group a: alpha-blocker plus mcs 30 mg/day group b: alpha-blocker plus placebo subjects are limited to those who are currently not being treated medically for bph or luts with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. for each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study. all participating subjects will be advised to maintain a normal diet as they do before joining the study. however, participating subjects are advised to refrain from extra source of carotenoids supplementation and mcs extracts made into a capsule, soft gel, or crude granule extracts.

Eligibility 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.

Keywords: benign prostatic hyperplasia mcs lower urinary tract symptoms international prostate symptom score voiding alpha-blockers