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Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia


Phase 1
40 Years
79 Years
Not Enrolling
Male
Prostatic Intraepithelial Neoplasia

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Trial Information

Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia


Observational studies suggest higher lycopene intake or higher lycopene blood levels are
associated with a lower risk for prostate cancer. Two recent trials of lycopene
supplementation conducted in men with prostate cancer, during the three weeks prior to
radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate
cancer.

High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men
with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The
objective of this study is to determine whether dietary lycopene supplementation lowers
serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is
compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus
standard multivitamin alone.


Inclusion Criteria:



- biopsy reported high grade prostatic intraepithelial neoplasia

- and/or biopsy reported atypia

- and/or persistently elevated serum prostate specific antigen with normal biopsy

Exclusion Criteria:

- biopsy diagnosed prostate cancer

- serum prostate specific antigen > 40 ng/ml

- hospitalization in past six months

- history of allergy to tomatoes

- history of allergic dermatitis

- serious concurrent illness

- inability to provide informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Serum PSA at randomization, one month, four months

Principal Investigator

Clareann H Bunker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

R01CA084950-05S1

NCT ID:

NCT00178113

Start Date:

July 2003

Completion Date:

July 2004

Related Keywords:

  • Prostatic Intraepithelial Neoplasia
  • Prostatic Intraepithelial Neoplasia
  • Prostate-Specific Antigen
  • lycopene
  • Neoplasms
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ

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