Clinical trial NCT00416390: Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
Official title: The Effect of Lycopene on DNA Damage in Human Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonmalignant Neoplasm
Prostate Cancer
Keywords: benign prostatic hyperplasia
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-28
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.

Detailed description: 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.

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.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Prostate cancer
  * Benign prostate hyperplasia
* High blood levels of prostate-specific antigen
* Enlarged prostate

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Ability of prostatic tissue to accumulate doses of lycopene
measure: Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
measure: Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
measure: Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Richard B. van Breemen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Breemen RB, Sharifi R, Viana M, Pajkovic N, Zhu D, Yuan L, Yang Y, Bowen PE, Stacewicz-Sapuntzakis M. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res (Phila). 2011 May;4(5):711-8. doi: 10.1158/1940-6207.CAPR-10-0288. Epub 2011 Mar 23.