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Completed

NCT Number: NCT02821728

Sulphate Accumulation in Prostate

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary intervention

Dietary 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 Diet

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. ADP

    Time frame: Biopsy on a single occasion at ≥ 4 weeks

    Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.

  2. Redox status of phosphatase proteins

    Time frame: Biopsy on a single occasion at ≥ 4 weeks

    The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Collaborators

  • Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Registry information

Official study title

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

Acronym: SAP

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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