Clinical trial · Interventional
Lycopene or Green Tea for Men at Risk of Prostate Cancer
Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
NCT01105338CI-TRIAL-00031320ProDietcompletedPhase 2 / Phase 3ClinicalTrials.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)
RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer. PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| green tea capsules | Dietary Supplement | — | UNRESOLVED |
| Green tea drink | Behavioral | — | UNRESOLVED |
| Green tea placebo capsules | Other | — | UNRESOLVED |
| Lycopene capsules | Dietary Supplement | — | UNRESOLVED |
| Lycopene placebo capsules | Other | — | UNRESOLVED |
| Tomato rich diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- Green tea drink
- description
- Green tea drink
- interventionNames
- Behavioral: Green tea drink
- type
- ACTIVE_COMPARATOR
- label
- Green tea capsules
- description
- Green tea capsules
- interventionNames
- Dietary Supplement: green tea capsules
- type
- PLACEBO_COMPARATOR
- label
- Green tea placebo capsules
- description
- Green tea placebo capsules
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria: PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy No major comorbidities No other cancers or prior prostate malignancy No history of allergic reactions to green tea or lycopene-containing products, including guava or watermelon Exclusion criteria: No concurrent finasteride or dutasteride
References
Publications (0)
Data not yet available
No reference posted for this study.