To Evaluate the Effect of MCS® in Prostate Cancer Prevention | NCT02042807

Studies
To Evaluate the Effect of MCS® in Prostate Cancer Prevention

NCT02042807

Sponsor

Health Ever Bio-Tech Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 13, 2024Actual

Enrollment

702Estimated

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Placebo
MCS®

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2024

Last Update Posted Date

Jun 13, 2024Actual

Description Module

Brief Summary

To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

702Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	placebo arm	Drug: Placebo
MCS® 15 mg/day	Active Comparator	MCS® soft capsule	Drug: MCS®
MCS® 30 mg/day	Active Comparator	MCS® soft capsule	Drug: MCS®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug		Placebo
MCS®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative biopsy-detectable prostate cancer rate		Week 104 (Month 24)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

high-risk subjects of prostate cancer.
Male subject with age from 50 to 75 years old.
Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

Exclusion Criteria:

Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
Subjects with a PSA > 10.0 ng/ml.
Subjects with a history of prostate cancer.
Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
Subjects are considered ineligible for the study as judged by the investigator.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, National Taiwan University Hospital		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided