A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group.
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.
Jatoi
Aminah
A
Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. jatoi.aminah@mayo.edu
Burch
Patrick
P
Hillman
David
D
Vanyo
Joanne M
JM
Dakhil
Shaker
S
Nikcevich
Daniel
D
Rowland
Kendrith
K
Morton
Roscoe
R
Flynn
Patrick J
PJ
Young
Charles
C
Tan
Winston
W
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
D000728:Androgens; D016588:Anticarcinogenic Agents; D002338:Carotenoids; D017430:Prostate-Specific Antigen; D000077276:Lycopene