The Effects of Lycopene on High Risk Prostatic Tissue - Full Text View

Purpose

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.

Condition	Intervention	Phase
Intraepithelial Prostatic Neoplasia Prostatic Neoplasms	Drug: Lycopene 30 mg or Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Lycopene

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

Tissue Biomarkers [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Changes in nuclear morphometry [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.
Changes in serum biomarkers [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	February 2006
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lycopene Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)	Drug: Lycopene 30 mg or Placebo Taken until clinically-indicated repeat biopsy performed (approximately 6 months) Other Name: Lyc-O-Mato
Placebo Comparator: Placebo Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)	Drug: Lycopene 30 mg or Placebo Taken until clinically-indicated repeat biopsy performed (approximately 6 months) Other Name: Lyc-O-Mato

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male
Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
Have an AUA symptom score <=25 at time of registration.
Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
Be willing to limit intake of lycopene-containing foods while on study
Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
Be ambulatory, capable of self-care and able to carry out light or sedentary work
Have a dietary fat intake of 23-48% of calories
Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion Criteria:

No repeat biopsy planned
Not willing to change diet
Have a diagnosis of prostate cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443026

Locations

United States, Illinois
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

University of Illinois

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Peter H Gann, MD, ScD

University of Illinois

More Information

Publications:

Clinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33.

Pastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5.

Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. Review.

Jain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84.

Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76.

Bostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002.

Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. German. No abstract available.

Responsible Party:	Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois
ClinicalTrials.gov Identifier:	NCT01443026 History of Changes
Other Study ID Numbers:	2005-0828, R01CA090759
Study First Received:	September 27, 2011
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Illinois:

Intraepithelial Prostatic Neoplasia
Prostatic neoplasms
Male urogenital disease
Prostate

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013