Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

NCT00416390 | Completed

• 2 other identifiers: CDR0000492778UIC-1999-0489
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

lycopene DIETARY_SUPPLEMENT

laboratory biomarker analysis OTHER

biopsy PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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.

  PMID: 21430075 DERIVED

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Lycopene; Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard B. van Breemen, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Completion: March 1, 2011
• Last Updated: September 20, 2013

Record last verified: 2007-10