title: A randomized trial of lycopene supplementation in Tobago men with high prostate cancer risk.
abstract: This unblinded, randomized, Phase I clinical trial was conducted to determine whether lycopene supplementation lowered serum prostate specific antigen (PSA), surrogate endpoint for prostate cancer initiation or progression, in men with elevated prostate cancer risk. Afro-Caribbean men (n=81) with high-grade prostatic intraepithelial neoplasia, atypical foci or repeated non-cancerous biopsies, ascertained in a population-based screening program, were randomized to four months intervention with 30 mg/day lycopene (Lyc-O-Mato) plus a multivitamin, or to multivitamin, only. Serum PSA and lycopene were compared at randomization, 1, and 4 mo using two-sided chi2 and t-tests for independent samples. Treatment groups were similar at baseline. Serum lycopene levels approximately doubled in the lycopene intervention group. Serum PSA declined during the first month of treatment, but returned to randomization level by month 4. The PSA response was nearly identical in both treatment groups. No adverse effects attributed to lycopene supplementation were documented. We conclude that the PSA lowering response to antioxidant supplementation observed in previous 3-wk studies in men awaiting prostatectomy may have been a transient response, perhaps not specific to lycopene. Lowering of serum PSA may not be an appropriate endpoint for the long-term studies needed to evaluate lycopene supplementation for reducing prostate cancer initiation or progression.
authors.affiliation: Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA 15261, USA. bunkerc+@pitt.edu
authors.forename: Clareann H
authors.initials: CH
authors.lastname: Bunker
authors.forename: Alicia C
authors.initials: AC
authors.lastname: McDonald
authors.forename: Rhobert W
authors.initials: RW
authors.lastname: Evans
authors.forename: Noreen
authors.initials: N
authors.lastname: de la Rosa
authors.forename: Jocelyne Matar
authors.initials: JM
authors.lastname: Boumosleh
authors.forename: Alan L
authors.initials: AL
authors.lastname: Patrick
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D016588:Anticarcinogenic Agents / Q000008:administration & dosage* / Q000097:blood; D000975:Antioxidants / Q000008:administration & dosage / Q000378:metabolism; D014408:Biomarkers, Tumor / Q000097:blood; D002338:Carotenoids / Q000008:administration & dosage* / Q000097:blood; D016009:Chi-Square Distribution; D019587:Dietary Supplements; D018450:Disease Progression; D006801:Humans; D000077276:Lycopene; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D019048:Prostatic Intraepithelial Neoplasia / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control; D011471:Prostatic Neoplasms / Q000097:blood* / Q000453:epidemiology* / Q000517:prevention & control; D012307:Risk Factors; D018709:Statistics, Nonparametric; D014300:Trinidad and Tobago / Q000453:epidemiology
chemical_list: D016588:Anticarcinogenic Agents; D000975:Antioxidants; D014408:Biomarkers, Tumor; D002338:Carotenoids; D017430:Prostate-Specific Antigen; D000077276:Lycopene