Prostate CancerESCAPENCT01950143
Effect of Sulforaphane on Prostate CAncer PrEvention
A study testing Standard broccoli soup, Beneforte broccoli soup and Beneforte extra broccoli soup in people with Prostate Cancer, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Standard broccoli soup, Beneforte broccoli soup and Beneforte extra broccoli soup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- chemopreventive therapy
- 5α-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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
About this study
Official title: 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 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.
Read more
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).
Read the detailed description
The study is a randomised double-blinded dietary intervention study. The study population will consist of smoking and non-smoking men aged between 18 and 80 years old. Participants recruited into this study will be randomly placed into one of three dietary groups in which they will be required to consume one portion of broccoli soup per week, delivering a different level of glucoraphanin (sulforaphane precursor), as part of their normal diet for one year. The three types of soup will contain (i)standard broccoli, (ii)glucoraphanin-enriched broccoli (Beneforte®), or (iii)Beneforte extra. Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom. In order to assess the habitual diet of the participants, they will be asked to keep three 7-day diet diaries, one pre-intervention, after 6-months and another one week before the end of their intervention. Considering the effect of exercise on whole body metabolism we will also obtain information on the physical activity of study participants. They will be asked to complete a validated physical activity questionnaire together with the diet diary (i.e before starting the study diet then at 6 and 12 months). Twenty six participants will be recruited to each of the broccoli groups. The participants will be characterised as having a low or intermediate risk of developing prostate cancer and will be undergoing active surveillance. A number of physiological tests will be performed on the participants before they start the dietary intervention (baseline) and after their 12 months on the intervention. The study will involve collection of prostate biopsies, blood and urine samples at baseline and after a 12 month dietary intervention. Prostate biopsies will be obtained through transperineal template biopsy (TPB) where possible or standard transrectal ultrasound scan guided biopsy (TRUS biopsy). TPB is a clinical procedure carried out under a general or regional anaesthetic which gives more detailed information about the position, amount and aggressiveness of the cancer within the prostate than other standard techniques. However, patients who do not wish to undergo TPB can alternatively choose the standard TRUS biopsy.
At the end of the trial participants will be asked to give written consent if they wish to continue the diet for a further 12 months. Consenting patients will thereafter be required to eat one portion of broccoli soup per week for 12-months. We will not ask participants to attend extra hospital visits for the purpose of the study or give additional biological samples; instead we will capture clinical data related to their follow up of prostate cancer.
It is anticipated that the dropout rate for this study will be approximately 25% due to the clinical progression of prostate cancer within the 12-month study period. In the event of clinical progression the volunteer will discontinue the intervention, receive advice from the urologist in charge and in case of prostatectomy will be asked to donate part of their prostate gland for research purposes.
- Conditions
- Prostate Cancer
- Being tested
- Standard broccoli soup, Beneforte broccoli soup, Beneforte extra broccoli soup
- Keywords
- prostate cancer prevention, diet, global gene expression, metabolic changes
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard broccoli soupDietary supplement
Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.
Beneforte broccoli soupDietary supplement
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.
Beneforte extra broccoli soupDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard broccoli soup | Active comparator | 26 volunteers Receives: Dietary Supplement: Standard broccoli soup |
| Beneforte broccoli soup | Experimental | 26 volunteers Receives: Dietary Supplement: Beneforte broccoli soup |
| Beneforte extra broccoli soup | Experimental | 26 volunteers Receives: Dietary Supplement: Beneforte extra broccoli soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (1)
metabolite concentration
To determine whether a 12 month diet rich in broccoli will results in changes in levels of metabolites in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2016
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation, Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor
- Investigators
- Richard Mithen, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950143
- Sponsor's protocol ID
- IFR01-2013
- Other IDs
- 14482
- Acronym
- ESCAPE
- Status last verified
- Jun 2016
- First submitted
- 23 Sep 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30982861
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Dietary Intervention Study to Investigate the Effect of Sulforaphane on Prostate Cancer Interception
- ClinicalTrials.gov ID
- NCT01950143
- Acronym / sponsor ID
- ESCAPE / IFR01-2013
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer prevention, diet, global gene expression, metabolic changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation, Biotechnology and Biological Sciences Research Council
- Study start
- Aug 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study is a randomised double-blinded dietary intervention study. The study population will consist of smoking and non-smoking men aged between 18 and 80 years old. Participants recruited into this study will be randomly placed into one of three dietary groups in which they will be required to consume one portion of broccoli soup per week, delivering a different level of glucoraphanin (sulforaphane precursor), as part of their normal diet for one year. The three types of soup will contain (i)standard broccoli, (ii)glucoraphanin-enriched broccoli (Beneforte®), or (iii)Beneforte extra. Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom. In order to assess the habitual diet of the participants, they will be asked to keep three 7-day diet diaries, one pre-intervention, after 6-months and another one week before the end of their intervention. Considering the effect of exercise on whole body metabolism we will also obtain information on the physical activity of study participants. They will be asked to complete a validated physical activity questionnaire together with the diet diary (i.e before starting the study diet then at 6 and 12 months). Twenty six participants will be recruited to each of the broccoli groups. The participants will be characterised as having a low or intermediate risk of developing prostate cancer and will be undergoing active surveillance. A number of physiological tests will be performed on the participants before they start the dietary intervention (baseline) and after their 12 months on the intervention. The study will involve collection of prostate biopsies, blood and urine samples at baseline and after a 12 month dietary intervention. Prostate biopsies will be obtained through transperineal template biopsy (TPB) where possible or standard transrectal ultrasound scan guided biopsy (TRUS biopsy). TPB is a clinical procedure carried out under a general or regional anaesthetic which gives more detailed information about the position, amount and aggressiveness of the cancer within the prostate than other standard techniques. However, patients who do not wish to undergo TPB can alternatively choose the standard TRUS biopsy.
At the end of the trial participants will be asked to give written consent if they wish to continue the diet for a further 12 months. Consenting patients will thereafter be required to eat one portion of broccoli soup per week for 12-months. We will not ask participants to attend extra hospital visits for the purpose of the study or give additional biological samples; instead we will capture clinical data related to their follow up of prostate cancer.
It is anticipated that the dropout rate for this study will be approximately 25% due to the clinical progression of prostate cancer within the 12-month study period. In the event of clinical progression the volunteer will discontinue the intervention, receive advice from the urologist in charge and in case of prostatectomy will be asked to donate part of their prostate gland for research purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard broccoli soup | Active comparator | Dietary Supplement: Standard broccoli soup26 volunteers |
| Beneforte broccoli soup | Experimental | Dietary Supplement: Beneforte broccoli soup26 volunteers |
| Beneforte extra broccoli soup | Experimental | Dietary Supplement: Beneforte extra broccoli soup26 volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- chemopreventive therapy
- 5α-reductase inhibitors or testosterone replacement medicines
- warfarin treatment
- diabetes
- high-risk for human immunodeficiency virus (HIV) and/or hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard broccoli soupVolunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year. | Dietary supplement | Standard broccoli soup |
| Beneforte broccoli soupVolunteers 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 broccoli soup |
| Beneforte extra broccoli soupVolunteers 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. | Dietary supplement | Beneforte extra broccoli soup |
Primary outcome
global gene expression
Time frame: Baseline and 12 months
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.
1 secondary outcome
metabolite concentration
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 30982861Traka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Mithen, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard broccoli soup, Beneforte broccoli soup and Beneforte extra broccoli soup in people with Prostate Cancer, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global gene expression (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.