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 χ ² 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.

Acknowledgments and Notes

This study was supported by funding or in-kind services from the Division of Health and Social Services, Tobago House of Assembly, the University of Pittsburgh Cancer Institute, contract DAMD 17-99-1-9015, U.S. Department of Defense, and grants R01 CA84950, R01 CA84950S1, U.S. National Cancer Institute. The Lyc-O-Mato® capsules were donated by Healthy Origins, Pittsburgh, PA.

Notes

^A Month 1, P ≤ 0.001;

^B Month 4, P ≤ 0.001.

^a P ≤ 0.001.

^b P ≤ 0.001.

^c P ≤ 0.025;

^d P ≤ 0.001.