NCT02042807

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
702

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

10.2 years

First QC Date

January 21, 2014

Last Update Submit

June 11, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Cumulative biopsy-detectable prostate cancer rate

    Week 104 (Month 24)

Study Arms (3)

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

PlaceboDRUG
Placebo
MCS®DRUG
MCS® 15 mg/dayMCS® 30 mg/day

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

TW(1)