Clinical trial · Interventional
Prostate Biomarkers in Men Consuming Tomato Products
NCT02292524CI-TRIAL-00016082completedN/AClinicalTrials.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)
Prostate Biomarkers in Men Consuming Tomato Products
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Commercially-available tomato food product | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Arm I: Control
- description
- Men in this group consumed a tomato free diet for the duration of the study (less than or equal to 5 mg lycopene/day) and, thus, did not consume a tomato intervention product.
- type
- EXPERIMENTAL
- label
- Arm II: Juice
- description
- Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day).
- interventionNames
- Other: Commercially-available tomato food product
- type
- EXPERIMENTAL
- label
- Arm III: Soup
- description
- Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be included in this study, men must: * Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies * Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options * Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits * Agree to sign consent form prior to enrollment in the study Exclusion Criteria: Men may not participate in this if they: * Are currently taking lycopene or "alternative" dietary supplements * Have a history of digestive or malabsorptive disorders, metabolic enzyme deficiencies, or other disorders requiring special dietary modifications (controlled type II diabetes mellitus was allowed)
References
Publications (0)
Data not yet available
No reference posted for this study.