The Effects of Lycopene on High Risk Prostatic Tissue

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gann, University of Illinois
ClinicalTrials.gov Identifier:
NCT01443026
First received: September 27, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.


Condition Intervention Phase
Intraepithelial Prostatic Neoplasia
Prostatic Neoplasms
Drug: Lycopene 30 mg or Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Tissue Biomarkers [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.


Secondary Outcome Measures:
  • Changes in nuclear morphometry [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

  • Changes in serum biomarkers [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lycopene
Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
Drug: Lycopene 30 mg or Placebo
Taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Other Name: Lyc-O-Mato
Placebo Comparator: Placebo
Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Drug: Lycopene 30 mg or Placebo
Taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Other Name: Lyc-O-Mato

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
  • Have an AUA symptom score <=25 at time of registration.
  • Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
  • Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
  • Be willing to limit intake of lycopene-containing foods while on study
  • Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
  • Be ambulatory, capable of self-care and able to carry out light or sedentary work
  • Have a dietary fat intake of 23-48% of calories
  • Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion Criteria:

  • No repeat biopsy planned
  • Not willing to change diet
  • Have a diagnosis of prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443026

Locations
United States, Illinois
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois
ClinicalTrials.gov Identifier: NCT01443026     History of Changes
Other Study ID Numbers: 2005-0828, R01CA090759
Study First Received: September 27, 2011
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
Intraepithelial Prostatic Neoplasia
Prostatic neoplasms
Male urogenital disease
Prostate

Additional relevant MeSH terms:
Neoplasms
Prostatic Intraepithelial Neoplasia
Prostatic Neoplasms
Carcinoma
Carcinoma in Situ
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014