Lycopene in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer
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)
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Mayo Clinic - Jacksonville
- CCOP - Atlanta Regional
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Duluth
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Medcenter One Health System
- CCOP - Dayton
- CCOP - Upstate Carolina
- CCOP - Sioux Community Cancer Consortium
Arms of the Study
Arm 1
Experimental
lycopene
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.