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Sulphate Accumulation in Prostate

A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02821728
Acronym
SAP
Enrollment
18
Registered
2016-07-04
Start date
2016-04-30
Completion date
2017-04-30
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate, Sulphate, ATP, PTEN

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTDietary intervention

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.

OTHERNormal diet

Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.

Sponsors

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
CollaboratorOTHER
Quadram Institute Bioscience
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Sulphate levelBiopsy on a single occasion at ≥ 4 weeksSulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.

Secondary

MeasureTime frameDescription
ADPBiopsy on a single occasion at ≥ 4 weeksAdenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
Redox status of phosphatase proteinsBiopsy on a single occasion at ≥ 4 weeksThe redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026