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A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

University of Pittsburgh logo

University of Pittsburgh

Status and phase

Completed
Phase 1

Conditions

Prostatic Intraepithelial Neoplasia

Treatments

Drug: - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
Drug: - Certagen (multivitamins with minerals)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00178113
R01CA084950-05S1
P200202-134PRC02-134

Details and patient eligibility

About

The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).

Full description

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.

Sex

Male

Ages

40 to 79 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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