A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group.

OBJECTIVES: 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.