Clinical trial NCT00535977: Broccoli, Peas and PIN
Official title: A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Intraepithelial Neoplasia
Keywords: Gene expression
Prostate
Broccoli
Cancer
Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 22
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Detailed description: Cancer is one of the main causes of death among humans in the world. Prostate cancer affects 20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. Previous research has indicated that glucosinolates break down to form isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that ITCs may protect the body against the development of prostate cancer. However, the mechanisms behind this effect are not fully understood.

ITCs are thought to be powerful anti cancer agents as they can modulate the expression (switching on or off) of specific genes involved in the removal of toxic substances such as carcinogens from the body. In this study we wish to evaluate the effect of consumption of a conventionally bred cultivar of broccoli containing high levels of ITCs on gene expression in prostate tissue to gain a better understanding of its mechanism of action. Several studies suggest a further protection against cancer amongst individuals who have a deletion of certain genes.

This pilot study comprises a 12-month intervention of either 400g ITC-enriched broccoli per week of 400g garden peas in men at high risk of developing prostate cancer. Changes in gene expression of prostate biopsy tissue will be compared before and after 6 and 12 months of intervention in both dietary groups.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in gene expression in RNA extracted from prostate tissue
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Changes in levels of serum prostate specific antigen (PSA)
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Food Research, Norwich
name: Richard F Mithen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.