Effect of Sulforaphane on prostate CAncer PrEvention (ESCAPE)

ISRCTN	ISRCTN40496794
DOI	https://doi.org/10.1186/ISRCTN40496794
ClinicalTrials.gov number	NCT01950143
Secondary identifying numbers	14482

Submission date: 11/10/2013
Registration date: 11/10/2013
Last edited: 22/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-effect-sulforaphane-prostate-cancer-escape

Contact information

Dr Antonietta Melchini
Scientific

Quadram Institute Bioscience
Norwich Research Park
Colney
NR4 7UA
United Kingdom

ORCID ID	0000-0001-5256-2724
Phone	+44 1603 255030
Email	antonietta.melchini@ifr.ac.uk

Study information

Study design	Randomised interventional trial ; Design type: Prevention, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A human dietary intervention study to investigate the effect of sulforaphane on prostate cancer interception
Study 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).
Ethics approval(s)	REC NRES Committee East of England-Cambridge South, 25/06/2013, ref: 13/EE/0110
Condition	Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
Intervention	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. Previous interventions: 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sulforaphane
Primary outcome measure	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 study start date	31/01/2013
Overall study end date	31/10/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Male
Target number of participants	UK Sample Size: 100
Total final enrolment	49
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 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	29/07/2013
Recruitment end date	31/10/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Norfolk and Norwich University Hospital

Colney Lane
Norwich
Colney
NR4 7UA
United Kingdom

Sponsor information

Quadram Institute Bioscience
Research organisation

Dr Linda Harvey
Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom

Website	www.quadram.ac.uk
"ROR"	https://ror.org/04td3ys19

Funders

Funder type

Charity

Prostate Cancer Foundation (UK)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): CaP CURE, PCF
Location: United States of America

Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Government organisation / National government

Alternative name(s): UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location: United Kingdom

Results and Publications

Intention to publish date	31/10/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2019	13/08/2019	Yes	No
Plain English results			22/06/2021	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

22/06/2021: Cancer Research UK lay results summary link added to Results (plain English).
13/08/2019: ClinicalTrials.gov number, publication reference and total final enrolment number added.
03/05/2017: Overall trial dates changed from 01/08/2013 - 02/02/2015 to 31/01/2013 - 31/10/2017. Recruitment dates changed from 01/08/2013 - 02/02/2015 to 29/07/2013 - 31/10/2016. Added sponsor information, trial participating site, publication and dissemination plan, intention to publish date, and IPD sharing plan. Updated interventions and outcome measures. Sponsor's changed from Institute of Food Research (UK) to Quadram Institute Bioscience, updated the sponsor information.
16/02/2017: No publications found in PubMed, verifying study status with principal investigator.