MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| Placebo Comparator: Placebo Placebo, 2 capsules per day |
Drug: Placebo
soft-gel capsule, Qd, 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- To evaluate the general safety and tolerability. [12 weeks]
Eligibility Criteria
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.
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No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.
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AST/ALT≦3X UNL.
-
creatinine≦3X UNL.
-
Subjects who sign the informed consent form.
Exclusion criteria
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Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
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Have been treated with pelvis irradiation or pelvic surgery.
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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.
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Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.
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Active infection or inflammation.
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Considered ineligible by the investigators.
Inclusion criteria for subproject MCS-3
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Age≧40 years old.
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The alpha-blocker dosage used should be as high as subjects can tolerate.
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No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital | Chiayi | Taiwan | 613 | |
| 2 | Chung-Ho Memorial Hospital,Kaohsiung Medical University | Kaohsiung | Taiwan | 807 | |
| 3 | Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | 807 | |
| 4 | China Medical University Hospital | Taichung | Taiwan | 404 | |
| 5 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- Health Ever Bio-Tech Co., Ltd.
Investigators
- Principal Investigator: Yeong-Shiau Pu, MD, PhD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCS for BPH-LUTS