| Randomized Study of Lycopene in Patients With Prostate Cancer or Benign Prostatic Hyperplasia
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
Basic Trial Information
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No phase specified
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Biomarker/Laboratory analysis, Prevention, Treatment
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Closed
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Not specified
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NCI
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UIC-1999-0489
NCT00416390
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Objectives - Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
- Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
- Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
- Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
- Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
- Measure prostate and blood uptake of the chemoprevention agent lycopene.
Entry Criteria Disease Characteristics:
- Diagnosis of 1 of the following:
- Prostate cancer
- Benign prostate hyperplasia
- High blood levels of prostate-specific antigen
- Enlarged prostate
Prior/Concurrent Therapy:
Patient Characteristics:
Expected Enrollment 120A total of 120 patients will be accrued for this study. Outcomes Primary Outcome(s)Ability of prostatic tissue to accumulate doses of lycopene
Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Prostate and blood uptake of the chemoprevention agent lycopene
Outline This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral lycopene once daily for 3 weeks.
- Arm II: Patients receive oral placebo once daily for 3 weeks.
In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy. Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
Trial Contact Information
Trial Lead Organizations University of Illinois Cancer Center | | | | Richard van Breemen, PhD, Principal investigator | | | |
| Registry Information | | | Official Title | | The Effect of Lycopene on DNA Damage in Human Prostate | | | Registered in ClinicalTrials.gov | | NCT00416390 | | | Date Submitted to PDQ | | 2006-07-07 | | | Information Last Verified | | 2007-10-15 | | | NCI Grant/Contract Number | | CA70771 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
