Clinical trial · Observational
Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention
NCT02426216CI-TRIAL-00019586unknownClinicalTrials.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)
This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group A
- description
- Group A: Subjects who fullfil all eligibility criteria of the MCS-8 protocol and consent to enroll the study.
- label
- Group B
- description
- Group B: Subjects who fullfil the definition of elevated risk for prostate cancer by the MCS-8 protocol but did not sign up for the MCS-8 study.
Primary outcomes (1)
- measure
- Cumulative histologically proven prostate cancer
- timeFrame
- up to 104 weeks
- description
- Cumulative histologically proven prostate cancer incidence at 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1\. Subject of MCS-8 study inclusion criteria of MCS-8 study 1. high-risk subjects of prostate cancer. 2. Male subject with age from 50 to 75 years old. 3. No active urinary tract infection (UTI) or bacterial prostatitis. 4. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF). exclusion criteria of MCS-8 study 1. Subjects' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate. 2. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. 3. Subjects with a PSA \> 10.0 ng/ml. 4. Subjects with a history of prostate cancer. 5. Subjects are currently taking or planning to take oral bile acid sequestrants. 6. Subjects have malabsorption conditions. 7. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. 8. Subjects are considered ineligible for the study as judged by the investigator. 9. Other malignancies except non-melanoma skin cancer. 2\. Subject is eligible for MCS-8 study but did not sign up for the MCS-8 study. Exclusion criteria: Subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (ICF). Note: (MCS-8-TWN-II Clinicaltrials.gov NCT02042807)
References
Publications (0)
Data not yet available
No reference posted for this study.