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

Clark PE, Hall MC, Borden LS, Miller AA, Hu JJ, Lee WR, Stindt D, D'Agostino R, Lovato J, Harmon M, Torti FM
Urology. 2006 67 (6): 1257-61

PMID: 16765186 · DOI:10.1016/j.urology.2005.12.035

OBJECTIVES - To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer.

METHODS - 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.

RESULTS - 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.

CONCLUSIONS - 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.

MeSH Terms (13)

Adenocarcinoma Aged Aged, 80 and over Anticarcinogenic Agents Carotenoids Humans Lycopene Male Middle Aged Neoplasm Recurrence, Local Prospective Studies Prostate-Specific Antigen Prostatic Neoplasms

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