In the last few years, the role of neoadjuvant hormonal treatment (NHT
) prior to radical prostatectomy has been largely debated and investig
ated in randomized multicenter trials as well as in large single-insti
tution studies. We have initiated a prospective randomized comparative
trial with parallel groups in patients with clinically limited diseas
e to contribute to the clarification of the possible role of NHT; to e
valuate the efficacy of NHT with leuprolide plus cyproterone acetate i
n 'maintaining' the stage of the disease; to reduce the percentage of
pathological overstaging, and mainly to accurately assess the patholog
ical modifications induced by NHT, The present paper is an interim rep
ort of the results.