Prostate Biomarkers in Men Consuming Tomato Products

NCT02292524 | Completed DMC

• 1 other identifier: OSU-0137
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate Biomarkers in Men Consuming Tomato Products

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce.

  Day 0 and End of Study (an average of 23 days)

Secondary Outcomes (2)

• Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade (number 1 - 10), tumor volume (weight) , and vascular endothelial growth factor expression (ng/mL)

  Day 0 and End of Study (an average of 23 days)

• Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)

  Day 0 and End of study (an average of 23 days)

Study Arms (4)

Arm I: Control

NO INTERVENTION

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.

Arm II: Juice

EXPERIMENTAL

Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day).

Other: Commercially-available tomato food product

Arm III: Soup

EXPERIMENTAL

Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).

Other: Commercially-available tomato food product

Arm IV: Sauce

EXPERIMENTAL

Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day).

Other: Commercially-available tomato food product

Interventions

Commercially-available tomato food product OTHER

Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Arm II: Juice; Arm III: Soup; Arm IV: Sauce

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Schwartz, Steven, PhD: collaborator

Study Sites (1)

The Ohio State University Comprehensive Cancer Center/ We

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Steven Clinton, MD

  The Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven Clinton

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 17, 2014
• Study Start: May 1, 2002
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

US (1)