First double-blind placebo-controlled, multicenter, randomized trial of stabilized natural sulforaphane in men with rising PSA following radical prostatectomy.

5032 Background: Sulforaphane (SF) is a natural compound present in cruciferous vegetables. It has demonstrated molecular targets. Its main problem is its instability in its free form. We have assessed the efficacy of a natural, stabilized SF in recurrent prostate cancer patients (pts) after radical prostatectomy (RP) ± adjuvant or salvage external radiotherapy (RT). Methods: In this multicenter trial, 81 pts, mean age 69 ± 6 years with a rising prostate-specific antigen (PSA) >0.2 ng/ml (and 5 and <36 months (M) participated in a double-blind, randomized, placebo (P) controlled study. Treatment consisted in 60 mg daily SF during six-months (M0-M6). A two months washout period (M6 to M8) followed. Clinical and biological assessments were performed at M0, M1, M3, M6 and M8. The study was designed to detect a 0.012 log(ng/ml)/month decrease in Log PSA slope in the SF arm compared to P. Results: Baseline parameters ...