4-year follow-up results of a European prospective randomized study on neoadjuvant hormonal therapy prior to radical prostatectomy in T2-3N0M0 prostate cancer

Objectives: To evaluate the long-term effects of 3-month neoadjuvant hormon al treatment in patients treated by radical prostatectomy for locally confi ned prostate cancer. Methods: We report the results of 402 patients (220 with a clinical T2 tumo r and 182 with a clinical T3 tumor) of whom 192 randomly received neoadjuva nt total androgen deprivation using a LHRH analogue (goserelin) plus flutam ide for a period of 3 months and 210 underwent radical prostatectomy only. Results: 'Clinical downstaging' was seen in 30% of cases in the neoadjuvant ly treated group (NEO). 'Pathological downstaging' occurred in 7 and 15% of cases in the direct radical prostatectomy (DP) group and the NEO group, re spectively (p<0.01). In patients with clinical T2 as well as in patients wi th clinical T3 tumors, a significant difference in the number of positive m argins was shown in favor of the NEO group (cT2, p<0.01; cT3, p = 0.01). Th is advantage, although there was a trend in favor of the NEO group, specifi cally in cT2 tumors, did not translate in a significantly better PSA progre ssion rate (p = 0.18). However, when evaluating the local control rate in c T2 tumors, we observed local recurrence in 3 of 102 (3%) patients in the NE O group versus 12 of 114 (11%) patients in the DP group. The difference is statistically significant (p = 0.03). In the cT3 group, this difference was not statistically significant (NEO group: 15 of 87 (17%), and DP group: 21 of 95 (22%) patients; p = 0.41). Conclusions: In this study, the clinical revelance of pathological downstag ing and the lower percentage of patients with positive margins in the neoad juvantly treated group with a clinical T2 tumor is not confirmed by a lower PSA progression rate. However, this study indicates that there may be a tr end that this advantage in favor of the NEO group directly translates into a better local control rate in clinical T2 tumors. Better local control in cT2 tumors is only going to be of relevance if subsequently you can show th at there is a better survival for these patients. Unfortunately, this artic le reports a study which is not yet mature enough to show relevant informat ion. Presently, neoadjuvant therapy should not be given outside clinical re search settings. Copyright (C) 2000 S. Karger AG, Basel.