Accumulation of Dietary Bioactives and Prostate Cancer
Research type
Research Study
Full title
A pre-biopsy window of opportunity trial to measure the dietary bioactive levels in the prostate following an intervention with Alliin and Sulforaphane dietary supplements
IRAS ID
258384
Contact name
Tracey Livingstone
Contact email
Sponsor organisation
Quadram Institute Bioscience
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
We propose to undertake an interventional trial on a group of men scheduled for a transperineal template prostate biopsy (TPB), to determine whether dietary supplements or their metabolites will accumulate within the prostate tissue itself. Furthermore, we aim to determine whether the accumulation of these metabolites differs spatially throughout the different anatomical zones of the prostate, alters gene expression, and are detectable globally in blood and urine.
We seek approval to undertake a double-blinded, randomised, factorial design study, in which patients will be randomised into one of four arms and required to consume 4 capsules once daily for a period of ≥4 weeks, made up of a combination of 2 of the following: Alliin/SACSO (derived from garlic), Sulforaphane (derived from broccoli), or placebo.
We will recruit men who have been diagnosed with, are under investigation, or on active surveillance for prostate cancer and require a transperineal template prostate biopsy (TPB) as part of their standard clinical care at the Norfolk and Norwich University Hospital (NNUH). 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 gland for analysis. The intervention will be carried out whilst the patients are awaiting their operation date, with no delay to their clinical care or investigations.
Participants in all arms of the study will consent for tissue biopsies, urine, and blood samples to be used for the purpose of the research. In addition, participants habitual diet will be assessed by 2 food frequency questionnaires in order to determine underlying intake of the bioactives in their normal diet.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0144
Date of REC Opinion
7 Jun 2019
REC opinion
Further Information Favourable Opinion