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

Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

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

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: MCS; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi, Taiwan, 613
    • Chang Gung Memorial Hospital
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital,Kaohsiung Medical University
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MCS; Group A: MCS 30 mg/day for 12 weeks	Drug: MCS; soft-gel capsule, 15 mg/cap., Qd, 12 weeks; Other Names: MUS
Placebo Comparator: Placebo; Placebo, 2 capsules per day	Drug: Placebo; soft-gel capsule, Qd, 12 weeks; Other Names: MUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.	12 weeks
MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the general safety and tolerability.	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 12, 2007
• First Posted (Estimate): July 16, 2007

Study Record Updates

• Last Update Posted (Estimate): December 14, 2011
• Last Update Submitted That Met QC Criteria: December 13, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: MCS; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; International prostate symptom score; Voiding; Alpha-blockers
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: MCS for BPH-LUTS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No