A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000327843
NCT00068731
January 2004
Name | Location |
---|---|
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 |