Effect of Sulforaphane on Prostate CAncer PrEvention
ESCAPE
A Human Dietary Intervention Study to Investigate the Effect of Sulforaphane on Prostate Cancer Interception
2 other identifiers
interventional
61
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Aug 2013
Typical duration for not_applicable prostate-cancer
1 active site
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
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedMarch 29, 2018
June 1, 2016
3.2 years
September 23, 2013
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
global gene expression
To determine whether a 12 month diet rich in broccoli will result in changes in global gene expression in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.
Baseline and 12 months
Secondary Outcomes (1)
metabolite concentration
Baseline and 12 months
Study Arms (3)
Standard broccoli soup
ACTIVE COMPARATOR26 volunteers
Beneforte broccoli soup
EXPERIMENTAL26 volunteers
Beneforte extra broccoli soup
EXPERIMENTAL26 volunteers
Interventions
Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.
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.
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.
Eligibility Criteria
You may qualify if:
- Males
- Diagnosed with low and intermediate prostate cancer on active surveillance
- Aged 18-80 years
- BMI between 19.5 and 35 kg/m2
- Smokers and non-smokers
You may not qualify if:
- chemopreventive therapy
- α-reductase inhibitors or testosterone replacement medicines
- warfarin treatment
- diabetes
- high-risk for human immunodeficiency virus (HIV) and/or hepatitis
- allergy to any of the ingredients of the broccoli soups
- dietary supplements or herbal remedies which may affect the study outcome
- parallel participation in another research project that involves dietary intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Quadram Institute Biosciencelead
- Prostate Cancer Foundationcollaborator
- Biotechnology and Biological Sciences Research Councilcollaborator
Study Sites (1)
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Related Publications (1)
Traka MH, Melchini A, Coode-Bate J, Al Kadhi O, Saha S, Defernez M, Troncoso-Rey P, Kibblewhite H, O'Neill CM, Bernuzzi F, Mythen L, Hughes J, Needs PW, Dainty JR, Savva GM, Mills RD, Ball RY, Cooper CS, Mithen RF. Transcriptional changes in prostate of men on active surveillance after a 12-mo glucoraphanin-rich broccoli intervention-results from the Effect of Sulforaphane on prostate CAncer PrEvention (ESCAPE) randomized controlled trial. Am J Clin Nutr. 2019 Apr 1;109(4):1133-1144. doi: 10.1093/ajcn/nqz012.
PMID: 30982861DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Mithen, PhD
Quadram Institute Bioscience
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2013
First Posted
September 25, 2013
Study Start
August 1, 2013
Primary Completion
October 1, 2016
Study Completion
October 31, 2017
Last Updated
March 29, 2018
Record last verified: 2016-06