The Effects of Lycopene on High Risk Prostatic Tissue

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443026
• Other study ID #: 2005-0828
• Secondary ID: R01CA090759
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: April 2009

Study information

• Verified date: November 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraepithelial Prostatic Neoplasia
• Neoplasms
• Prostatic Intraepithelial Neoplasia
• Prostatic Neoplasms

Intervention

Drug:
• Lycopene 30mg
Lycopene 30 mg.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. German. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Biomarkers	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.	baseline and 6 months
Primary	Changes in Serum Biomarkers	Change in serum lycopene, umol/L	baseline and 6 months
Secondary	Changes in Nuclear Morphometry	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.	baseline and 6 months