Indolent prostate cancer, phytochemicals and probiotics
Research type
Research Study
Full title
Do probiotics aid men with indolent prostate cancer in addition to a phytochemical-rich, whole-plant supplement? A randomised, double-blind, placebo-controlled trial
IRAS ID
321309
Contact name
Zahoor Fazili
Contact email
Sponsor organisation
Bedfordshire Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN81939514
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
The relevance of gut health is becoming increasingly recognised as trials are emerging linking dysbiosis with a greater prostate cancer (PCa) risk and progression. Various dietary and lifestyle factors influence microbiome composition, but probiotic supplements have been shown to improve the flora composition to a more favourable, less inflammatory profile. Likewise, studies have linked higher intake of biologically active compounds found in plants (phytochemical-rich foods), with a lower risk of PCa and progression of the prostate cancer tumour marker, prostate specific antigen (PSA). Phytochemicals have numerous direct and indirect anti-cancer properties including reducing excess chronic inflammation, which can damage healthy tissue, and enhancing oxidative pathways (release of stored chemical energy), but they also act as plant fibres that help healthy bacteria grow (prebiotics), which support commensal and ingested probiotic bacteria. The hypothesis for this double-blind, randomised trial is that a probiotic supplement could enhance the benefits of a phytochemical-rich supplement via this synergistic effect. A combination of phytochemical-rich foods and probiotic supplements has not previously been explored in a cohort of men with PCa, and hence the rationale for this double-blind, randomised trial.
In this trial, 180 participants will be asked to stop all existing over-the-counter supplements and will be given a specifically designed phytochemical-rich food supplement for 4 months. Participants will be randomised (1:1) to a probiotic supplement or placebo. Trial end points will be PSA doubling time (an indicator of biochemical and clinical progression) measured at baseline and 4 months; prostate symptoms (urinary symptoms and erectile function) measured by two standard questionnaires, which are routinely used in clinic. A secondary end point measures grip strength as a marker of overall wellbeing.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0190
Date of REC Opinion
16 Aug 2023
REC opinion
Favourable Opinion