Lycopene in Treating Patients With Metastatic Prostate Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation|
|Study Start Date:||January 2004|
- 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.
- 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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068731
|United States, Arizona|
|CCOP - Mayo Clinic Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|CCOP - Atlanta Regional|
|Atlanta, Georgia, United States, 30342-1701|
|United States, Illinois|
|CCOP - Illinois Oncology Research Association|
|Peoria, Illinois, United States, 61615-7828|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|Sioux City, Iowa, United States, 51101-1733|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Coborn Cancer Center|
|Saint Cloud, Minnesota, United States, 56303|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, North Dakota|
|Medcenter One Health System|
|Bismarck, North Dakota, United States, 58501-5505|
|United States, Ohio|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, South Dakota|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Investigator:||Joanne M. Vanyo, MSN||Allegheny Cancer Center at Allegheny General Hospital|