Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
lycopene
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Toxicity as measured by NCI CTC v2.0
Feasibility of daily consumption of prescribed volumes of the formulation
Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months
Pharmacokinetics at 1 and 3 months
Tissue distribution of lycopene (oral mucosa and prostate tissue)
Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue
Modulation of serum prostate-specific antigen
Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA)
Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue
Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present)
Secondary Outcome Measures
Full Information
NCT ID
NCT00416325
First Posted
December 27, 2006
Last Updated
June 25, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00416325
Brief Title
Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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 from forming in patients at high risk of developing prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in patients who are at high risk of developing 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.
Define the pharmacokinetics and tissue distribution in patients receiving this regimen.
Characterize surrogate endpoint biomarkers (SEBs) in the peripheral blood, buccal mucosa, and the prostate itself, which will provide evidence of biological activity relevant to a chemoprevention effect.
Characterize the oxidative stress state of the individual by studies of DNA oxidation in the prostate and buccal mucosa, as well as DNA oxidation and lipid peroxidation within the peripheral blood.
Define the effects of lycopene through a food delivery system on prostate histology (prostatic intraepithelial neoplasia), markers of cellular proliferation [PCNA], and apoptosis in the prostate.
Evaluate the effects of lycopene on the serum levels of total prostate-specific antigen (PSA), free PSA, and PSA density.
Provide the basic knowledge in reference to toxicity, pharmacokinetics, and SEBs needed to proceed to a large phase II or III lycopene study in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral lycopene in tomato paste and olive oil, once, twice, or three times daily for 3 months.
Cohorts of 6 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients undergo buccal scrapings and blood collection periodically during study for pharmacokinetics and biomarker studies.
After completion of study treatment, patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Toxicity as measured by NCI CTC v2.0
Title
Feasibility of daily consumption of prescribed volumes of the formulation
Title
Serum lycopene levels, including other carotenoids and lipid soluble vitamins, at 1 and 3 months
Title
Pharmacokinetics at 1 and 3 months
Title
Tissue distribution of lycopene (oral mucosa and prostate tissue)
Title
Modulation of surrogate endpoint biomarkers which include oxidative stress in blood, oral mucosa, and prostate tissue
Title
Modulation of serum prostate-specific antigen
Title
Cellular proliferation as measured by proliferating cell nuclear antigen (PCNA)
Title
Apoptosis as measured by Terminal deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling in prostate tissue
Title
Serum levels of insulin-like growth factor (IGF-1) and the modulation of prostate histology (prostatic intraepithelial neoplasia [PIN], when and if present)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith A. Rodvold
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26422197
Citation
Gann PH, Deaton RJ, Rueter EE, van Breemen RB, Nonn L, Macias V, Han M, Ananthanarayanan V. A Phase II Randomized Trial of Lycopene-Rich Tomato Extract Among Men with High-Grade Prostatic Intraepithelial Neoplasia. Nutr Cancer. 2015;67(7):1104-12. doi: 10.1080/01635581.2015.1075560.
Results Reference
derived
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Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
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