Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| response duration | Up to 5 years |
| time to the first consistent PSA increase | Up to 5 years |
| disease regression | Up to 5 years |
Countries
United States