title: A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group.
abstract: OBJECTIVE
  Tomatoes are rich in lycopene. This study explored the efficacy of a lycopene-rich tomato product in androgen-independent prostate cancer and the reasons patients participated in an "alternative medicine" study.
  
  
  METHODS
  This Phase II study evaluated 46 patients with androgen-independent prostate cancer. All were asymptomatic and had serum prostate-specific antigen elevation despite hormonal manipulation. All patients completed a questionnaire on their motivations for enrolling in an "alternative medicine" study. Patients were prescribed a lycopene-rich tomato supplement at a lycopene dose of 15 mg twice daily.
  
  
  RESULTS
  One patient manifested a tumor response with a 50% or greater confirmed decline in serum prostate-specific antigen level, yielding a response rate of 2%. Lycopene was well tolerated, but 1 patient died of a cancer-related hemorrhage, and 1 had grade 4 diarrhea. Grade 1 or 2 events included diarrhea in 18, nausea in 12, abdominal distension in 8, flatulence in 2, vomiting in 2, anorexia in 1, and dyspepsia in 1. The reasons for entering the trial are discussed and were overall positive.
  
  
  CONCLUSIONS
  Lycopene, as prescribed in our study, did not appear effective for androgen-independent prostate cancer. The patients' reasons for enrolling in this trial were positive and realistic.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. jatoi.aminah@mayo.edu
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Patrick
authors.initials: P
authors.lastname: Burch
authors.forename: David
authors.initials: D
authors.lastname: Hillman
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Vanyo
authors.forename: Shaker
authors.initials: S
authors.lastname: Dakhil
authors.forename: Daniel
authors.initials: D
authors.lastname: Nikcevich
authors.forename: Kendrith
authors.initials: K
authors.lastname: Rowland
authors.forename: Roscoe
authors.initials: R
authors.lastname: Morton
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Charles
authors.initials: C
authors.lastname: Young
authors.forename: Winston
authors.initials: W
authors.lastname: Tan
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000378:metabolism*; D016588:Anticarcinogenic Agents / Q000627:therapeutic use; D001707:Biopsy, Needle; D002338:Carotenoids / Q000627:therapeutic use*; D000529:Complementary Therapies; D019587:Dietary Supplements; D005500:Follow-Up Studies; D006801:Humans; D000077276:Lycopene; D018551:Solanum lycopersicum; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009376:Neoplasms, Hormone-Dependent / Q000473:pathology / Q000628:therapy; D018579:Patient Selection; D011336:Probability; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D016588:Anticarcinogenic Agents; D002338:Carotenoids; D017430:Prostate-Specific Antigen; D000077276:Lycopene