Effect of Sulforaphane on Prostate CAncer PrEvention

NCT01950143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-03-29

No results posted yet for this study

Summary

The biology of prostate cancer is associated with changes in genes and metabolites within prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent or retard the development of prostate cancer by influencing these changes. This is likely to be due to a natural chemical that is obtained in these vegetables known as sulforaphane.

In this study, we are seeking to provide further evidence that a diet rich in broccoli may prevent prostate cancer from developing, and to understand how this may happen. We propose to undertake a human intervention study to test the hypothesis that a broccoli-rich diet can alter the metabolism and gene expression within prostate tissue of men under active surveillance in a manner that would reduce the probability of the emergence and progression of aggressive cancerous clones. Participants recruited onto this study will be randomly allocated to one of three dietary groups in which they will be required to consume one portion per week of a broccoli soup delivering a different concentration of sulforaphane. This will be part of their normal diet for one year.

Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month intervention period. Prostate biopsies will be obtained either though transperineal template biopsies, a technique accepted as best clinical practice because it provides better sampling of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies.

This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).

Conditions

Interventions

DIETARY_SUPPLEMENT

Standard broccoli soup

Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.

DIETARY_SUPPLEMENT

Beneforte broccoli soup

Volunteers will be required to consume one portion per week of a soup containing glucoraphanin-enriched broccoli (Beneforte®) as part of their normal diet for one year.

DIETARY_SUPPLEMENT

Beneforte extra broccoli soup

Volunteers will be in which they will be required to consume one portion per week of a soup containing an other variety of glucoraphanin-enriched broccoli (Beneforte extra) as part of their normal diet for one year.

Sponsors & Collaborators

  • Quadram Institute Bioscience

    lead OTHER
  • Prostate Cancer Foundation

    collaborator OTHER
  • Biotechnology and Biological Sciences Research Council

    collaborator OTHER

Principal Investigators

  • Richard Mithen, PhD · Quadram Institute Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-10-31
Completion
2017-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950143 on ClinicalTrials.gov