Prostate CancerSAPNCT02821728
Sulphate Accumulation in Prostate
A study testing Dietary intervention and Normal diet in people with Prostate Cancer, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dietary intervention and Normal diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males
- Scheduled for TPB as part of routine investigation or staging for prostate cancer
- Aged 18-80 years
- BMI between 19.5 and 35 kg/m2
- Smokers and non-smokers
Who cannot join
- Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
- Those on warfarin treatment
- Those diagnosed with diabetes
- Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
- Those allergic to any of the ingredients of the broccoli soups
- Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
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- Those that are unable to understand English or give informed consent
- Parallel participation in another research project that involves dietary intervention
- Any person related to or living with any member of the study team
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
Official title: A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.
Read the detailed description
Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.
The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.
Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.
- Conditions
- Prostate Cancer
- Being tested
- Dietary intervention, Normal diet
- Keywords
- Prostate, Sulphate, ATP, PTEN
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionDietary supplement
Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.
Normal dietOther
Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | Experimental | No dietary intervention Receives: Other: Normal diet |
| Dietary intervention | Experimental | 3 portions of broccoli soup per week Receives: Dietary Supplement: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulphate level
Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
Measured: Biopsy on a single occasion at ≥ 4 weeks
Secondary outcomes (2)
ADP
Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
Measured: Biopsy on a single occasion at ≥ 4 weeks
Redox status of phosphatase proteins
The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.
Measured: Biopsy on a single occasion at ≥ 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionApr 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
- Investigators
- Richard Mithen, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821728
- Sponsor's protocol ID
- IFR01/2016
- Acronym
- SAP
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Coode-Bate J, Sivapalan T, Melchini A, Saha S, Needs PW, Dainty JR, Maicha JB, Beasy G, Traka MH, Mills RD, Ball RY, Mithen RF. Accumulation of Dietary S-Methyl Cysteine Sulfoxide in Human Prostate Tissue. Mol Nutr Food Res. 2019 Oct;63(20):e1900461. doi: 10.1002/mnfr.201900461. Epub 2019 Sep 11.
PubMed 31410992
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
- ClinicalTrials.gov ID
- NCT02821728
- Acronym / sponsor ID
- SAP / IFR01/2016
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Sulphate, ATP, PTEN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Jul 2016 (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.
This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.
Detailed description
Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.
The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.
Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diet | Experimental | Other: Normal dietNo dietary intervention |
| Dietary intervention | Experimental | Dietary Supplement: Dietary intervention3 portions of broccoli soup per week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males
- Scheduled for TPB as part of routine investigation or staging for prostate cancer
- Aged 18-80 years
- BMI between 19.5 and 35 kg/m2
- Smokers and non-smokers
Key exclusion criteria (9 listed)
- Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
- Those on warfarin treatment
- Those diagnosed with diabetes
- Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
- Those allergic to any of the ingredients of the broccoli soups
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 |
|---|---|---|
| Dietary interventionParticipants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin. | Dietary supplement | Dietary intervention |
| Normal dietParticipants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy. | Other | Normal diet |
Primary outcome
Sulphate level
Time frame: Biopsy on a single occasion at ≥ 4 weeks
Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
2 secondary outcomes
ADP
Time frame: Biopsy on a single occasion at ≥ 4 weeks
Redox status of phosphatase proteins
Time frame: Biopsy on a single occasion at ≥ 4 weeks
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 2 Jun 2017.
- Derived from this study: PubMed 31410992Coode-Bate J, Sivapalan T, Melchini A, Saha S, Needs PW, Dainty JR, Maicha JB, Beasy G, Traka MH, Mills RD, Ball RY, Mithen RF. Accumulation of Dietary S-Methyl Cysteine Sulfoxide in Human Prostate Tissue. Mol Nutr Food Res. 2019 Oct;63(20):e1900461. doi: 10.1002/mnfr.201900461. Epub 2019 Sep 11.
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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 Dietary intervention and Normal diet 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 9 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 2 Jun 2017. 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?
Sulphate level (time frame: Biopsy on a single occasion at ≥ 4 weeks). 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 NCT02821728, 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 2 Jun 2017.