title: Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Urology and Comprehensive Cancer Center, Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, USA. peclark@wfubmc.edu
authors.forename: Peter E
authors.initials: PE
authors.lastname: Clark
authors.forename: M Craig
authors.initials: MC
authors.lastname: Hall
authors.forename: Lester S
authors.initials: LS
authors.lastname: Borden
authors.forename: Antonius A
authors.initials: AA
authors.lastname: Miller
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Hu
authors.forename: W Robert
authors.initials: WR
authors.lastname: Lee
authors.forename: Diana
authors.initials: D
authors.lastname: Stindt
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.forename: James
authors.initials: J
authors.lastname: Lovato
authors.forename: Michelle
authors.initials: M
authors.lastname: Harmon
authors.forename: Frank M
authors.initials: FM
authors.lastname: Torti
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D000368:Aged; D000369:Aged, 80 and over; D016588:Anticarcinogenic Agents / Q000008:administration & dosage*; D002338:Carotenoids / Q000008:administration & dosage*; D006801:Humans; D000077276:Lycopene; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000628:therapy
chemical_list: D016588:Anticarcinogenic Agents; D002338:Carotenoids; D017430:Prostate-Specific Antigen; D000077276:Lycopene