A randomised double‐blind phase II study of lifestyle counselling and salicylate compounds in patients with progressive prostate cancer

Abstract

PurposeSalicylate intake and lifestyle have been implicated in the aetiology of prostate cancer, but the purpose of this paper is to evaluate their influence on established cancer progression.Design/methodology/approachA randomised, double blind, phase II study involving 110 men whose prostate specific antigen (PSA), had risen in three consecutive values, >20 per cent over the proceeding six months. Men were counselled to eat less saturated fat, processed food, more fruit, vegetables and legumes; exercise more regularly and to stop smoking. They were then randomised to take sodium salicylate (SS) alone or SS combined with, vitamin C, copper and manganese gluconates (CV247). Patients took this daily, without other intervention, but were withdrawn if their PSA doubling time (PSAdt) shortened or their PSA rose >20 per cent from baseline.FindingsAlthough there was no difference in outcome between the SS or CV247 (21 v 19 p = 0.92), the intervention slowed or stopped the rate of PSA progression in 40 patients (36.4 per cent) for over one year. A further ten patients were stabilised for ten months. Patients least likely to stabilise had received previous radiotherapy or had a Gleason ≥7. These men welcomed this addition to active surveillance.Originality/valueA further RCT in the sensitive subgroup, would determine the role adding SS to lifestyle counselling alone. These data suggest that this intervention would be welcomed by patients as if substantiated, it could potentially delay the need for more radical therapy and their associated toxicities