Status:
COMPLETED
Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
35-75 years
Phase:
PHASE1
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer ...
Detailed Description
OBJECTIVES: * Define the toxicity and safety of lycopene administered as a food-based delivery system as a chemoprevention agent in patients who are at a high risk of developing prostate cancer. * De...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Elevated prostate-specific antigen (PSA), meeting 1 of the following criteria:
- PSA \> 4.0 ng/mL for patients at any age
- PSA \> 2.0 ng/mL for patients 35 to 49 years of age
- PSA rise (velocity) of \> 0.75 ng/mL over the past year
- Has undergone a prostate biopsy\* (following findings of elevated PSA) within the past 180 days that failed to reveal prostate cancer
- Prostate intraepithelial neoplasia allowed NOTE: \*At least 4 core biopsies are considered acceptable
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- WBC ≥ 3,000/mm\^3
- Hemoglobin ≥ 11.0 g/dL
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 125,000/mm\^3
- No history of gastrointestinal malabsorption or other condition affecting drug absorption
- No history of food allergy to tomato-based products
- No history of any chronic medical condition that, in the judgment of the investigator, may pose threat or additional risk to the patient (including a current history of alcohol or drug abuse)
- No active history of cancer or other illnesses that, in the opinion of the investigator, could represent a threat to patient's life, including congestive heart failure or uncontrolled hypertension
- PRIOR CONCURRENT THERAPY:
- No participation in any other experimental trial within the past 4 weeks
- No concurrent chronic use of nonsteroidal anti-inflammatory drugs
- No concurrent participation in another experimental trial
- No concurrent supplements (except multivitamins), including herbal and soy products
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00416325
End Date
September 1 2006
Last Update
June 26 2013
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