title: Phase II randomized clinical trial of lycopene supplementation before radical prostatectomy.
abstract: An inverse association has been observed between dietary intake of lycopene and the risk of prostate cancer. We investigated the effects of lycopene supplementation in patients with prostate cancer. Twenty-six men with newly diagnosed, clinically localized (14 T(1) and 12 T(2)) prostate cancer were randomly assigned to receive 15 mg of lycopene (n = 15) twice daily or no supplementation (n = 11) for 3 weeks before radical prostatectomy. Biomarkers of differentiation and apoptosis were assessed by Western blot analysis on benign and malignant parts of the prostate gland. Prostatectomy specimens were entirely embedded, step-sectioned, and evaluated for pathological stage, Gleason score, volume of cancer, and extent of high-grade prostatic intraepithelial neoplasia. Plasma levels of lycopene, insulin-like growth factor-1 (IGF-1), IGF binding protein-3, and prostate-specific antigen were measured at baseline and after 3 weeks of supplementation or observation. Eleven (73%) subjects in the intervention group and two (18%) subjects in the control group had no involvement of surgical margins and/or extra-prostatic tissues with cancer (P = 0.02). Twelve (84%) subjects in the lycopene group and five (45%) subjects in the control group had tumors <4 ml in size (P = 0.22). Diffuse involvement of the prostate by high-grade prostatic intraepithelial neoplasia was present in 10 (67%) subjects in the intervention group and in 11 (100%) subjects in the control group (P = 0.05). Plasma prostate-specific antigen levels decreased by 18% in the intervention group, whereas they increased by 14% in the control group (P = 0.25). Expression of connexin 43 in cancerous prostate tissue was 0.63 +/- 0.19 absorbance in the lycopene group compared with 0.25 +/- 0.08 in the control group (P = 0.13). Expression of bcl-2 and bax did not differ significantly between the two study groups. IGF-1 levels decreased in both groups (P = 0.0002 and P = 0.0003, respectively). The results suggest that lycopene supplementation may decrease the growth of prostate cancer. However, no firm conclusions can be drawn at this time because of the small sample size.
authors.affiliation: Division of Hematology and Oncology, Wayne State University, and Barbara Ann Karmanos Cancer Institute, Detroit, MI 48201, USA. kucuko@karmanos.org
authors.forename: O
authors.initials: O
authors.lastname: Kucuk
authors.forename: F H
authors.initials: FH
authors.lastname: Sarkar
authors.forename: W
authors.initials: W
authors.lastname: Sakr
authors.forename: Z
authors.initials: Z
authors.lastname: Djuric
authors.forename: M N
authors.initials: MN
authors.lastname: Pollak
authors.forename: F
authors.initials: F
authors.lastname: Khachik
authors.forename: Y W
authors.initials: YW
authors.lastname: Li
authors.forename: M
authors.initials: M
authors.lastname: Banerjee
authors.forename: D
authors.initials: D
authors.lastname: Grignon
authors.forename: J S
authors.initials: JS
authors.lastname: Bertram
authors.forename: J D
authors.initials: JD
authors.lastname: Crissman
authors.forename: E J
authors.initials: EJ
authors.lastname: Pontes
authors.forename: D P
authors.initials: DP
authors.lastname: Wood
mesh_terms: D000284:Administration, Oral; D000368:Aged; D016588:Anticarcinogenic Agents / Q000494:pharmacology*; D017209:Apoptosis; D014408:Biomarkers, Tumor / Q000032:analysis*; D002338:Carotenoids / Q000494:pharmacology*; D019587:Dietary Supplements; D006801:Humans; D000077276:Lycopene; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy; D019048:Prostatic Intraepithelial Neoplasia / Q000473:pathology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000517:prevention & control* / Q000601:surgery
chemical_list: D016588:Anticarcinogenic Agents; D014408:Biomarkers, Tumor; D002338:Carotenoids; D000077276:Lycopene