Condition category
Cancer
Date applied
11/10/2013
Date assigned
11/10/2013
Last edited
11/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Antonietta Melchini

ORCID ID

Contact details

Institute of Food Research
Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom
antonietta.melchini@ifr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14482

Study information

Scientific title

A human dietary intervention study to investigate the effect of sulforaphane on prostate cancer interception

Acronym

ESCAPE

Study hypothesis

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).

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14482

Ethics approval

First MREC approval date 25/06/2013, ref: 13/EE/0110

Study design

Randomised interventional trial ; Design type: Prevention, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Sulforaphane

Primary outcome measures

Global gene expression; Timepoints: 12 months post intervention

Secondary outcome measures

Metabolite concentration; Timepoints: 12 months after intervention

Overall trial start date

01/08/2013

Overall trial end date

02/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males
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

Participant type

Patient

Age group

Adult

Gender

Male

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

01/08/2013

Recruitment end date

02/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Food Research
Colney
NR4 7UA
United Kingdom

Sponsor information

Organisation

Institute of Food Research (UK)

Sponsor details

Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom

Sponsor type

Research organisation

Website

http://www.ifr.ac.uk/

Funders

Funder type

Charity

Funder name

Prostate Cancer Foundation (UK)

Alternative name(s)

PCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Biotechnology and Biological Sciences Research Council (BBSRC) (UK)

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes