Lycopene in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Dietary Supplement: lycopene
- Registration Number
- NCT00068731
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lycopene 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method response duration Up to 5 years disease regression Up to 5 years time to the first consistent PSA increase Up to 5 years
Trial Locations
- Locations (18)
CCOP - Mayo Clinic Scottsdale Oncology Program
๐บ๐ธScottsdale, Arizona, United States
CCOP - Metro-Minnesota
๐บ๐ธSaint Louis Park, Minnesota, United States
CCOP - Upstate Carolina
๐บ๐ธSpartanburg, South Carolina, United States
CCOP - Cedar Rapids Oncology Project
๐บ๐ธCedar Rapids, Iowa, United States
Siouxland Hematology-Oncology
๐บ๐ธSioux City, Iowa, United States
CCOP - Carle Cancer Center
๐บ๐ธUrbana, Illinois, United States
CCOP - Illinois Oncology Research Association
๐บ๐ธPeoria, Illinois, United States
CCOP - Atlanta Regional
๐บ๐ธAtlanta, Georgia, United States
Mayo Clinic - Jacksonville
๐บ๐ธJacksonville, Florida, United States
CCOP - Duluth
๐บ๐ธDuluth, Minnesota, United States
CCOP - Sioux Community Cancer Consortium
๐บ๐ธSioux Falls, South Dakota, United States
Coborn Cancer Center
๐บ๐ธSaint Cloud, Minnesota, United States
CCOP - Wichita
๐บ๐ธWichita, Kansas, United States
Medcenter One Health System
๐บ๐ธBismarck, North Dakota, United States
CCOP - Iowa Oncology Research Association
๐บ๐ธDes Moines, Iowa, United States
CCOP - Ochsner
๐บ๐ธNew Orleans, Louisiana, United States
CCOP - Dayton
๐บ๐ธDayton, Ohio, United States
Mayo Clinic Cancer Center
๐บ๐ธRochester, Minnesota, United States