Clinical trial NCT01443026: The Effects of Lycopene on High Risk Prostatic Tissue
Official title: R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraepithelial Prostatic Neoplasia
Prostatic Neoplasms
Keywords: Intraepithelial Prostatic Neoplasia
Prostatic neoplasms
Male urogenital disease
Prostate
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-29
Enrollment: 66
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Tissue Biomarkers
timeFrame: baseline and 6 months
measure: Changes in Serum Biomarkers
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes in Nuclear Morphometry
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peter H Gann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1006/bbrc.1998.9351.
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. doi: 10.1093/jnci/91.4.317.
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. doi: 10.1207/S15327914NC3402_8.
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. doi: 10.1093/jnci/87.23.1767.
citation: 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. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2.
citation: Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German.