Status:
COMPLETED
Prostate Biomarkers in Men Consuming Tomato Products
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Schwartz, Steven, PhD
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Prostate Biomarkers in Men Consuming Tomato Products
Detailed Description
Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions. Men were randomized to one of the followin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02292524
Start Date
May 1 2002
End Date
October 1 2004
Last Update
November 17 2014
Active Locations (1)
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1
The Ohio State University Comprehensive Cancer Center/ We
Columbus, Ohio, United States, 43210