Plain English Summary
A human dietary intervention study to investigate the effect of sulforaphane on prostate cancer interception
The biology of prostate cancer is associated with changes in genes and metabolites within prostate tissue. There is robust evidence to suggest that isothiocyanates (ITCs), compounds found in broccoli and other cruciferous vegetables, can affect the development of prostate cancer by influencing these changes.
We propose to undertake a dietary intervention study on a group of men with early prostate cancer on active surveillance in order to investigate changes in genes and other measurable compounds in prostate, blood and urine that would reflect the activity of prostate disease. Volunteers recruited onto this study will be randomly allocated to one of three dietary groups in which they will be required to consume two portions of broccoli soup per week, delivering a different concentration of sulforaphane (SF) as part of their normal diet for one year. SF is one of most abundant ITCs found in broccoli and has been proven to have many health promoting properties.
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 we will use transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies in the NHS.
This study builds upon and extends a successful pilot study of similar design undertaken between 2006 and 2008 (REC Ref: 05/Q0101/9). The proposed study has a similar experimental design but with some important differences to enable acquisition of further information regarding diet and prostate biology.
This study will be funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).
REC NRES Committee East of England-Cambridge South, 25/06/2013, ref: 13/EE/0110
Randomised interventional trial ; Design type: Prevention, Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
Current interventions as of 03/05/2017:
ESCAPE is a double-blind, randomised 12 month dietary intervention trial on men with early prostate cancer on active surveillance. The study takes place at the Human Nutrition Unit (HNU) of the Institute of Food Research (IFR) and at the urology clinic at the Norfolk and Norwich University Hospital (NNUH). Participants are asked to attend one visit at the HNU for a talk and three or four visits to the NNUH depending on the technique of prostate biopsy. Participants are randomly allocated to one of three dietary groups in which they will be required to consume one portion of broccoli soup per week, delivering a different concentration of the dietary bioactive sulforaphane (SF) as part of their normal diet for one year. SF is one of most abundant sulfur compound found in broccoli and has been proven to have many health promoting properties. Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month intervention period. Prostate biopsies are obtained either though transperineal template biopsies, a technique accepted as best clinical practice because it provides better sampling of the prostate or using transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies in the NHS.
Broccoli soups, Volunteers recruited into this study will be randomly placed in one of three dietary groups in which they will be required to consume two portions of broccoli soup per week, delivering a different level of glucoraphanin (SF precursor), as part of their normal diet for one year.
The three types of soup will contain:
1. standard broccoli
2. glucoraphanin-enriched broccoli (Beneforte®) (
3. Beneforte extra
Beneforte and Beneforte extra broccoli are especially cultivated to deliver high SF.
Study Entry : Single Randomisation only
Primary outcome measures
Current primary outcome measures as of 03/05/2017:
Global gene expression is measured using prostate tissue samples at baseline and 12 months.
Previous primary outcome measures:
Global gene expression; Timepoints: 12 months post intervention
Secondary outcome measures
Current secondary outcome measures as of 03/05/2017:
Metabolite concentration is measured using prostate tissue samples at baseline and 12 months.
Previous secondary outcome measures:
Metabolite concentration; Timepoints: 12 months after intervention
Overall trial start date
Overall trial end date
Participant inclusion criteria
2. Diagnosed with low and intermediate prostate cancer on active surveillance
3. Aged 18-80 years
4. Body mass index (BMI) between 19.5 and 35 kg/m2
5. Smokers and non-smokers
Target number of participants
UK Sample Size: 100
Participant exclusion criteria
1. Those undergoing chemopreventive therapy
2. Those regularly taking 5a-reductase inhibitors or testosterone replacement medicines
3. Those on warfarin treatment
4. Those diagnosed with diabetes
5. Those diagnosed with or suspected to be high-risk for HIV and/or hepatitis
6. Those allergic to any of the ingredients of the broccoli soups
7. Those taking dietary supplements or herbal remedies which may affect the study outcome unless the volunteer is willing to discontinue taking them for 1 month prior to starting study. Please note that some supplements may not affect the study and this will be assessed on an individual basis
8. Parallel participation in another research project which involves dietary intervention
9. Any person related to or living with any member of the study team
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Norfolk and Norwich University Hospital
Colney Lane Norwich
Quadram Institute Bioscience
Dr Linda Harvey
Norwich Research Park
Prostate Cancer Foundation (UK)
Funding Body Type
private sector organisation
Funding Body Subtype
United States of America
Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting