Long‐term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high‐risk prostate cancer

Objective To determine long‐term oncological outcomes of radical prostatectomy ( RP ) after neoadjuvant chemohormonal therapy ( CHT ) for clinically localised, high‐risk prostate cancer. Patients and Methods In this phase II multicentre trial of patients with high‐risk prostate cancer ( PSA level >20 ng/mL, G leason ≥8, or clinical stage ≥ T 3), androgen‐deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP . We report the long‐term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only. Results In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence ( BCR ‐free probability 22%; 95% confidence interval [ CI ] 10–37%). However, the probability of disease‐specific survival at 10 years was 84% (95% CI 66–93%) and overall survival was 78% (95% CI 60–89%). The CHT group had higher‐risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5‐year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [ HR ] 0.76, 95% CI 0.43–1.34; P = 0.3) and metastasis‐free survival ( HR 0.55, 95% CI 0.24–1.29; P = 0.2) although these were not statistically significant. Conclusions Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP ‐only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial.