Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Prostatic Intraepithelial Neoplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Other Dietary Supplements

Lycopene

Antioxidants

Protective Agents

Radiation-Protective Agents

Lycopene 30mg

Placebo

Peter H Gann, MD, ScD

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

The Effects of Lycopene on High Risk Prostatic Tissue

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.

We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

National Cancer Institute (NCI)

University of Illinois at Chicago

Professor and Director, Division of Pathology Research

Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)

Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Peter Gann

Tissue Biomarkers

Changes in Serum Biomarkers

Changes in Nuclear Morphometry

Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effects of Lycopene on High Risk Prostatic Tissue	NCT01443026	Intraepithelial... Prostatic Neopl...	Lycopene 30mg Placebo	40 Years -	University of Illinois at Chicago
The Effects of Lycopene on High Risk Prostatic Tissue	NCT01443026	Intraepithelial... Prostatic Neopl...	Lycopene 30mg Placebo	40 Years -	University of Illinois at Chicago

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