A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Aminah Jatoi, MD
United States: Federal Government
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Dayton||Kettering, Ohio 45429|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|Coborn Cancer Center||Saint Cloud, Minnesota 56303|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|