Clinical trial · Interventional
To Evaluate the Effect of MCS® in Prostate Cancer Prevention
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
NCT02042807CI-TRIAL-00077921MCS-8unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCS® | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo arm
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- MCS® 15 mg/day
- description
- MCS® soft capsule
- interventionNames
- Drug: MCS®
- type
- ACTIVE_COMPARATOR
- label
- MCS® 30 mg/day
- description
- MCS® soft capsule
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. high-risk subjects of prostate cancer. 2. Male subject with age from 50 to 75 years old. 3. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF). Exclusion Criteria: 1. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. 2. Subjects with a PSA \> 10.0 ng/ml. 3. Subjects with a history of prostate cancer. 4. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. 5. Subjects are considered ineligible for the study as judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.