Sulphate Accumulation in Prostate (SAP)
Research type
Research Study
Full title
A pre-biopsy window of opportunity trial to measure sulphate levels in human prostate after broccoli consumption
IRAS ID
197753
Contact name
Richard Mithen
Contact email
Sponsor organisation
Institute of Food research
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
We propose to undertake a dietary intervention trial on a group of men scheduled for a biopsy procedure of the prostate to determine whether a diet rich in broccoli will induce a difference in the levels of sulphate and other associated metabolites in prostate tissue. Furthermore, we aim to determine whether the accumulation of these metabolites is specific to the prostate gland or whether they occur in urine and other tissue such as adipose (fat).
We seek approval to undertake an unblinded, randomised, 2-arm trial (non-interventional arm and dietary intervention arm). We will recruit men who have been diagnosed or are under investigation for prostate cancer and require a transperineal template prostate biopsy (TPB) as part of their standard clinical care. The proposed study does not require the participants to have any additional clinical procedures but, during routine sampling, separate tissue cores will be taken from the prostate and adjacent adipose tissue. Participants in one arm will consume three portions of broccoli and stilton soup per week for at least four weeks prior to their TPB, whereas participants randomised to the other arm will not have any diet intervention prior to biopsy. The intervention will be carried out while the patients are awaiting their operation date, with no delay to their clinical care or investigations. Participants in both arms will consent for tissue biopsies (prostate and adipose tissues), blood and urine samples to be used for the purpose of this research. In addition, participant's habitual intake of cruciferous vegetables such as broccoli will be assessed by a food frequency questionnaire specifically designed for these types of vegetable.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0054
Date of REC Opinion
26 Feb 2016
REC opinion
Favourable Opinion