lycopene in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: lycopene, a substance found in tomatoes, may lower prostate-specific antigen (psa) levels and slow or prevent the development of prostate cancer. purpose: phase ii trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising psa level.

objectives: primary * determine the percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (psa) level who sustain a decline in psa after 4 months of treatment with lycopene. secondary * determine the response duration of psa decline in patients treated with this therapy. * determine the time to the first consistent psa increase in patients treated with this therapy. * determine whether a decline in psa coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy. * determine the adverse event profile of this therapy in these patients. * determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study. outline: this is a multicenter study. patients receive oral lycopene twice daily on days 1-28. courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Eligibility criteria:
disease characteristics: * diagnosis of androgen-independent prostate cancer * asymptomatic metastatic disease * unlikely to become symptomatic within the next 4 months * no bone pain, shortness of breath, fatigue, or urinary symptoms directly attributable to prostate cancer * radiologic, physically palpable, and/or biochemical evidence of tumor progression after prior orchiectomy or during treatment with a luteinizing hormone-releasing hormone (lhrh) agonist or after initiation of another hormonal agent * sustained prostate-specific antigen (psa) elevation, defined by the following: * psa greater than 5 ng/ml * at least 2 consecutive increases in psa at least 1 week apart * sustained increase in psa at least 4 weeks after discontinuation of prior flutamide (or other antiandrogen therapy) or megestrol and at least 6 weeks after discontinuation of prior bicalutamide * no known cns metastases or carcinomatous meningitis patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * not specified hepatic * bilirubin no greater than 1.5 mg/dl\* note: \*includes patients with liver involvement secondary to tumor renal * see disease characteristics * creatinine no greater than 2 times upper limit of normal pulmonary * see disease characteristics other * no other malignancy within the past 5 years except basal cell skin cancer * no medical or psychiatric condition that would preclude study participation prior concurrent therapy: biologic therapy * more than 4 weeks since prior immunotherapy chemotherapy * more than 4 weeks since prior chemotherapy * no concurrent chemotherapy endocrine therapy * see disease characteristics * more than 4 weeks since prior hormonal therapy (other than an lhrh agonist) * no concurrent corticosteroids * no concurrent progestational agents * no concurrent new hormonal therapy radiotherapy * no concurrent radiotherapy, including radiotherapy for new bone disease surgery * see disease characteristics other * more than 4 weeks since other prior anticancer therapy * no other concurrent investigational anticancer agents * no other concurrent alternative medicine therapies (e.g., saw palmetto or pc-spes)

Keywords: stage iv prostate cancer recurrent prostate cancer