Clinical trial · Interventional
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
NCT00178113CI-TRIAL-00018041completedPhase 1ClinicalTrials.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)
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).
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 |
|---|---|---|---|
| Prostatic Intraepithelial Neoplasia | Prostatic Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| - Certagen (multivitamins with minerals) | Drug | — | UNRESOLVED |
| - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Serum PSA at randomization, one month, four months
Secondary outcomes (1)
- measure
- Serum lycopene at randomization, one month, four months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy reported high grade prostatic intraepithelial neoplasia * and/or biopsy reported atypia * and/or persistently elevated serum prostate specific antigen with normal biopsy Exclusion Criteria: * biopsy diagnosed prostate cancer * serum prostate specific antigen \> 40 ng/ml * hospitalization in past six months * history of allergy to tomatoes * history of allergic dermatitis * serious concurrent illness * inability to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.