Neoadjuvant hormonal therapy prior to radical prostatectomy: the European experience.

Background and purpose: Neoadjuvant hormonal therapy (NHT) has been used for more than a decade for prostate cancer, but the results of clinical trials are only now becoming available, and the value of the treatment is not yet clear. The authors reviewed the results of the European randomized trials to increase our understanding of the role of this treatment.

Patients and methods: We report the results of 402 patients with prostate cancer (220 clinical stage T(2) and 182 clinical T(3) tumor), of whom 192 were randomly assigned to NHT using an LHRH analog (goserelin) plus flutamide for a period of 3 months (NHT) and 210 underwent radical prostatectomy only (RP).

Results: "Pathologic downstaging" occurred in 15% and 7% of the NHT and the RP group, respectively (P < 0.01). Fifty of the 189 patients in the NHT group (26%) and 68 of the 209 patients in the RP group (33%) developed disease progression, as determined by rising serum prostate specific antigen (PSA) concentration. Regarding local disease progression, the advantage for the use of NHT approached but did not reach statistical significance:18 of 189 patients (10%) in the NHT group and 33 of 209 patients (16%) in the RP group (P = 0. 07).

Conclusions: Although there was a trend in favor of the NHT group with respect to the number of patients with PSA progression and the number with local disease progression, it did not reach statistical significance. These results may be attributable to a true lack of benefit of adjuvant hormonal ablation or to a lack of statistical power to demonstrate a difference in a subset of patients who might benefit from this therapy.