Long-term follow-up of 3-month neoadjuvant hormone therapy before radical prostatectomy in a randomized trial

To report our long-term follow-up of an institutional randomized prospective trial of radical prostatectomy (RP) with or without a 3-month course of neoadjuvant hormone therapy (NHT), which results in pathological downstaging, but generally no reduction in biochemical recurrence (BCR) on early follow-up (at 3 years).

From December 1992 to June 1996, 148 patients with clinically localized prostate cancer were randomized to RP only or 3 months of goserelin acetate and flutamide before RP. BCR was defined as a detectable serum prostate specific antigen level (>0.1 ng/mL) at least 6 weeks after surgery, with a confirmatory increase.

The median follow-up for BCR-free patients was 8 years. There was no significant difference in BCR-free probabilities between groups (P = 0.7). The BCR-free probability at 7 years was 78% for patients undergoing RP only and 80% for patients undergoing NHT and RP (difference of 2%; 95% confidence interval, CI, 12-16%). A Cox regression showed no significant relationship between NHT and BCR (hazard ratio 1.16; 95% CI, 0.56-2.39, P = 0.7). Overall, two patients had local recurrence and six developed metastases, and were evenly distributed among the RP only and NHT groups.

Although our study was not originally powered to detect differences in BCR, there was no overall benefit in BCR-free probability, local recurrence or metastasis with 3 months of NHT at 8 years of follow-up. Pending evidence of improvement in patient outcomes, NHT before RP appears to be unjustified outside of clinical trials.