Prostate Biomarkers in Men Consuming Tomato Products
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
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)
Sites / Locations
- The Ohio State University Comprehensive Cancer Center/ We
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Arm I: Control
Arm II: Juice
Arm III: Soup
Arm IV: Sauce
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.
Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day).
Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).
Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day).