NCT00535977

Brief Summary

This is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

September 26, 2007

Last Update Submit

September 26, 2007

Conditions

Prostatic Intraepithelial Neoplasia

Keywords

Gene expressionProstateBroccoliCancerMen diagnosed with high-grade Prostatic Intraepithelia Neoplasia

Outcome Measures

Primary Outcomes (1)

  • Changes in gene expression in RNA extracted from prostate tissue

    Baseline, 6 months and 12 months

Secondary Outcomes (1)

  • Changes in levels of serum prostate specific antigen (PSA)

    Baseline, 6 months and 12 months

Study Arms (2)

1

EXPERIMENTAL

Dietary intervention of ITC-enriched broccoli

Dietary Supplement: Broccoli

2

EXPERIMENTAL

Dietary intervention of frozen peas

Dietary Supplement: Peas

Interventions

BroccoliDIETARY_SUPPLEMENT

400g ITC-enriched broccoli per week for 12 months

1
PeasDIETARY_SUPPLEMENT

400g frozen garden peas per week for 12 months

2

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with a previous diagnosis of high-grade Prostatic Intraepithelial Neoplasia
  • BMI \>18.5 or \<35
  • Aged between 30-70 years

You may not qualify if:

  • Undergoing chemopreventive therapy
  • Receiving testosterone replacement medicines
  • Active infection requiring treatment
  • BMI \<18.5 or \>35
  • Diagnosed with diabetes
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Chiao JW, Chung FL, Kancherla R, Ahmed T, Mittelman A, Conaway CC. Sulforaphane and its metabolite mediate growth arrest and apoptosis in human prostate cancer cells. Int J Oncol. 2002 Mar;20(3):631-6. doi: 10.3892/ijo.20.3.631.

    PMID: 11836580BACKGROUND

  • Cotton SC, Sharp L, Little J, Brockton N. Glutathione S-transferase polymorphisms and colorectal cancer: a HuGE review. Am J Epidemiol. 2000 Jan 1;151(1):7-32. doi: 10.1093/oxfordjournals.aje.a010124.

    PMID: 10625170BACKGROUND

  • Fenwick GR, Heaney RK, Mullin WJ. Glucosinolates and their breakdown products in food and food plants. Crit Rev Food Sci Nutr. 1983;18(2):123-201. doi: 10.1080/10408398209527361. No abstract available.

    PMID: 6337782BACKGROUND

  • Gamet-Payrastre L, Li P, Lumeau S, Cassar G, Dupont MA, Chevolleau S, Gasc N, Tulliez J, Terce F. Sulforaphane, a naturally occurring isothiocyanate, induces cell cycle arrest and apoptosis in HT29 human colon cancer cells. Cancer Res. 2000 Mar 1;60(5):1426-33.

    PMID: 10728709BACKGROUND

  • Giovannucci E, Rimm EB, Liu Y, Stampfer MJ, Willett WC. A prospective study of cruciferous vegetables and prostate cancer. Cancer Epidemiol Biomarkers Prev. 2003 Dec;12(12):1403-9.

    PMID: 14693729BACKGROUND

  • Hecht SS. Inhibition of carcinogenesis by isothiocyanates. Drug Metab Rev. 2000 Aug-Nov;32(3-4):395-411. doi: 10.1081/dmr-100102342.

    PMID: 11139137BACKGROUND

  • Hintze KJ, Keck AS, Finley JW, Jeffery EH. Induction of hepatic thioredoxin reductase activity by sulforaphane, both in Hepa1c1c7 cells and in male Fisher 344 rats. J Nutr Biochem. 2003 Mar;14(3):173-179. doi: 10.1016/s0955-2863(02)00282-6.

    PMID: 12742546BACKGROUND

  • Key TJ, Silcocks PB, Davey GK, Appleby PN, Bishop DT. A case-control study of diet and prostate cancer. Br J Cancer. 1997;76(5):678-87. doi: 10.1038/bjc.1997.445.

    PMID: 9303371BACKGROUND

  • Mithen R, Faulkner K, Magrath R, Rose P, Williamson G, Marquez J. Development of isothiocyanate-enriched broccoli, and its enhanced ability to induce phase 2 detoxification enzymes in mammalian cells. Theor Appl Genet. 2003 Feb;106(4):727-34. doi: 10.1007/s00122-002-1123-x. Epub 2002 Oct 24.

    PMID: 12596003BACKGROUND

  • Surh YJ. Cancer chemoprevention with dietary phytochemicals. Nat Rev Cancer. 2003 Oct;3(10):768-80. doi: 10.1038/nrc1189.

    PMID: 14570043BACKGROUND

  • Traka M, Gasper AV, Melchini A, Bacon JR, Needs PW, Frost V, Chantry A, Jones AM, Ortori CA, Barrett DA, Ball RY, Mills RD, Mithen RF. Broccoli consumption interacts with GSTM1 to perturb oncogenic signalling pathways in the prostate. PLoS One. 2008 Jul 2;3(7):e2568. doi: 10.1371/journal.pone.0002568.

    PMID: 18596959DERIVED

MeSH Terms

Conditions

Prostatic Intraepithelial NeoplasiaNeoplasms

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Richard F Mithen, PhD

    Institute of Food Research, Norwich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

September 27, 2007

Record last verified: 2007-09