Clark Peter E, Hall M Craig, Borden Lester S, Miller Antonius A, Hu Jennifer J, Lee W Robert, Stindt Diana, D'Agostino Ralph, Lovato James, Harmon Michelle, Torti Frank M
Department of Urology and Comprehensive Cancer Center, Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, USA.
Urology. 2006 Jun;67(6):1257-61. doi: 10.1016/j.urology.2005.12.035.
To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer.
A total of 36 men with biochemically relapsed prostate cancer were enrolled in a dose-escalating, Phase I-II trial of lycopene supplementation. Six consecutive cohorts of 6 patients each received daily supplementation with 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels of prostate-specific antigen (PSA) and plasma levels of lycopene were measured at baseline and every 3 months. The primary endpoints were PSA response (defined as a 50% decrease in serum PSA from baseline), pharmacokinetics, and the toxicity/tolerability of this regimen.
A total of 36 patients were enrolled. The median age was 74 years (range 56 to 83), with a median serum PSA at entry of 4.4 ng/mL (range 0.8 to 24.9). No serum PSA responses were observed, and 37% of patients had PSA progression. The median time to progression was not reached. Toxicity was mild, with 1 patient discontinuing therapy because of diarrhea. Significant elevations of plasma lycopene were noted at 3 months and then appeared to plateau for all six dose levels. The plasma levels for doses between 15 and 90 mg/day were similar, with additional elevation only at 120 mg/day.
Lycopene supplementation in men with biochemically relapsed prostate cancer is safe and well tolerated. The plasma levels of lycopene were similar for a wide dose range (15 to 90 mg/day) and plateaued by 3 months. Lycopene supplementation at the doses used in this study did not result in any discernible response in serum PSA.
报告一项关于番茄红素补充剂用于生化复发前列腺癌的前瞻性试验。
共有36名生化复发前列腺癌男性患者参加了一项番茄红素补充剂的剂量递增I-II期试验。连续6组，每组6名患者，每天分别补充15、30、45、60、90和120毫克，持续1年。在基线时以及每3个月测量血清前列腺特异性抗原（PSA）水平和血浆番茄红素水平。主要终点为PSA反应（定义为血清PSA较基线水平降低50%）、药代动力学以及该方案的毒性/耐受性。
共纳入36例患者。中位年龄为74岁（范围56至83岁），入组时血清PSA中位数为4.4纳克/毫升（范围0.8至24.9）。未观察到血清PSA反应，37%的患者出现PSA进展。未达到进展的中位时间。毒性轻微，1例患者因腹泻停止治疗。在3个月时血浆番茄红素显著升高，然后在所有六个剂量水平似乎趋于平稳。15至90毫克/天剂量之间的血浆水平相似，仅在120毫克/天时进一步升高。
生化复发前列腺癌男性补充番茄红素是安全且耐受性良好的。在较宽剂量范围（15至90毫克/天）内，血浆番茄红素水平相似，并在3个月时趋于平稳。本研究中使用的剂量补充番茄红素未导致血清PSA出现任何可察觉的反应。
