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R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

Phase 2
40 Years
Not Enrolling
Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms

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Trial Information

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Tissue Biomarkers

Outcome Description:

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.

Outcome Time Frame:

baseline and 6 months

Safety Issue:


Principal Investigator

Peter H Gann, MD, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

April 2009

Related Keywords:

  • Intraepithelial Prostatic Neoplasia
  • Prostatic Neoplasms
  • Intraepithelial Prostatic Neoplasia
  • Prostatic neoplasms
  • Male urogenital disease
  • Prostate
  • Neoplasms
  • Prostatic Neoplasms
  • Prostatic Intraepithelial Neoplasia



Northwestern Memorial Hospital Chicago, Illinois  60611
Jesse Brown VA Medical Center Chicago, Illinois  60612