Indolent prostate cancer, phytochemicals and probiotics

INTERVENTION: This is a double‐blind, randomised, controlled trial in men who have a diagnosis of indolent prostate cancer managed with surveillance alone. Following written informed consent, patients will be randomised (1:1) to: • Men in one randomised arm (blinded) will receive a phytochemical‐rich food supplement (PFS) containing whole dried pomegranate, turmeric, green tea, broccoli, cranberry and ginger plus a probiotic capsule containing a blend of 10 billion colony‐forming units (CFU) of 5 lactobacilli plus inulin and low dose cholecalciferol as prebiotics. • Men in the other blinded randomised group will be given the PFS plus placebo Each capsule will be taken twice a day, for 4 months. Participants are asked to stop all other over‐the‐counter supplements The phytochemical‐rich capsule contains dried whole foods which have previously been reported as safe among men with prostate cancer in prospective studies. The ingredients of both supplements have been shown to have a high safety profile. This blend has been used in two previous studies and was safe and well‐tolerated. Computer generated Block Randomisation will be employed. A spreadsheet will be created; in column 1, sequential participant numbers will be recorded. In column 2, block‐generated randomised Arms (A or B), will be recorded. After a participant has consented they will be allocated the next trial number and randomised Arm in strict order. Participants will be given a four‐month supply of either "A" or "B" plus the whole food supplement. Contact will be face‐to‐face consultations with the medical team at baseline and at trial termination during their routine clinical management for surveillance. Loca CONDITION: Indolent prostate cancer ; Cancer PRIMARY OUTCOME: Prostatic specific antigen doubling time (PSAdt) measured using a routine blood test analysis at trial entry baseline and 4 months SECONDARY OUTCOME: ; The following secondary outcome measures will be assessed at baseline and 4 months:; 1. Urinary symptoms measured using the International Prostate Symptoms score; 2. Erectile function measured using the validated International Inde Xof Erectile Function; 3. Grip strength measured using a portable Hand help grip strength dynameter; INCLUSION CRITERIA: 1. Histologically confirmed prostate cancer 2. Written informed consent 3. No current androgen deprivation or other medication for prostate cancer 4. Patients who are willing to comply with an oral food supplement 5. Patients who are willing to cease all non‐trial, over‐the‐counter oral food supplements 6. Patients considered for surveillance or watch and wait for strategy, following multidisciplinary team discussion