Results of a European randomized study comparing radical prostatectomy andradical prostatectomy plus neoadjuvant hormonal combination therapy in stage T2-3N0M0 prostatic carcinoma

We report the results of 402 patients (220 with a clinical Stage T-2 prosta te cancer and 182 with a T-3 cancer) of whom 192 randomly received neoadjuv ant hormone therapy (NHT) using a luteinizing hormone releasing hormone (LH RH) analog (goserelin) plus flutamide for a period of 3 months. Serum prost ate specific antigen (PSA) concentrations and prostatic volumes decreased f rom a mean of 20.5 ng/mL and 37.7 cc to a mean of 0.8 ng/mL and 26.8 cc, re spectively, after 3 months of NHT. Clinical downstaging was seen in 30% of the neoadjuvantly treated patients. Pathologic downstaging occurred in 7% o f the direct radical prostatectomy group and 15% of the neoadjuvantly treat ed group (P <0.01). In patient with cT(2) disease, as well as in patients w ith cT(3) tumors, a significant difference in the number of positive margin s was shown in favor of the neoadjuvantly treated group (cT(2), P < 0.01; c T(3), P = 0.01). In the neoadjuvantly treated group, 50 of 189 patients (26 %) and in the direct prostatectomy group, 68 of 209 patients (33%) develope d a progression. (PSA data were not available for four patients.) The mean duration of progression-free survival was 45.7 (95% CI 41.7-49.9) months in the NHT group and 43.1 (95% CI 38.6-47.6) months in the prostatectomy-only group. The difference was not statistically significant (log-rank P = 0.18 ). There was significantly more pathologic downstaging and a significantly lower percentage of patients with positive margins in the neoadjuvantly tre ated group. The clinical relevance of this advantage in favor of neoadjuvan t treatment is not yet confirmed, as after 4 years of follow-up, the analys is of time to PSA progression did not reveal significant differences betwee n treatment groups. At present, neoadjuvant therapy is not advisable outsid e clinical research settings.