Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy

作者: Peter E. Clark , M. Craig Hall , Lester S. Borden , Antonius A. Miller , Jennifer J. Hu

DOI: 10.1016/J.UROLOGY.2005.12.035

关键词:

摘要: Abstract Objectives To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer. Methods A total 36 men with cancer were enrolled dose-escalating, Phase I-II supplementation. Six consecutive cohorts 6 patients each received daily 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels prostate-specific antigen (PSA) plasma measured at baseline every 3 months. primary endpoints PSA response (defined as 50% decrease from baseline), pharmacokinetics, the toxicity/tolerability this regimen. Results enrolled. median age was 74 years (range 56 to 83), entry 4.4 ng/mL 0.8 24.9). No responses observed, 37% had progression. time progression not reached. Toxicity mild, patient discontinuing therapy because diarrhea. Significant elevations noted months then appeared plateau all six dose levels. doses between 15 90 similar, additional elevation only mg/day. Conclusions Lycopene is safe well tolerated. similar wide range (15 mg/day) plateaued by used study did result any discernible PSA.

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