Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00416325
• Date of registration: 27/12/2006
• Primary sponsor: University of Illinois
• Public title: Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
• Scientific title: Phase I Multiple Dose Pharmacokinetic Study of Lycopene Delivered in a Well-Defined Food-Based Lycopene Delivery System (Tomato Paste-Oil Mixture) in Patients at Increased Risk for Developing Prostate Cancer
• Date of first enrolment: July 2006
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00416325
• Study type: Interventional
• Study design: Primary Purpose: Prevention

Contacts

• Name: Keith A. Rodvold
• Affiliation: University of Illinois

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Dietary Supplement: lycopene

Other: laboratory biomarker analysis

Primary Outcome(s)

Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue [Time Frame: No]

Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) [Time Frame: No]

Feasibility of daily consumption of prescribed volumes of the formulation [Time Frame: No]

Modulation of serum prostate-specific antigen [Time Frame: No]

Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue [Time Frame: No]

Pharmacokinetics at 1 and 3 months [Time Frame: No]

Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present) [Time Frame: No]

Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months [Time Frame: No]

Tissue distribution of lycopene (oral mucosa and prostate tissue) [Time Frame: No]

Toxicity as measured by NCI CTC v2.0 [Time Frame: Yes]

Secondary ID(s)

CDR0000467322

UIC-2000-0931

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)