Objectives: To verify whether in patients with biochemical progression after radical prostatectomy (RRP), the administration of a cyclooxygenase-2 (COX-2) inhibitor during the off-phases of intermittent androgen deprivation (IAD) may increase the effectiveness and off-therapy time of intermittent therapy.
Methods: This is a comparative, prospective study. A total of 44 patients with biochemical progression after RRP were included in a clinical protocol for IAD once prostate-specific antigen (PSA) levels progressed over 0.4 ng/mL. The 44 cases were randomly assigned to receive two different treatment strategies: group A received IAD therapy using bicalutamide 150 mg once daily in the on-phases and no therapy in the off-phases; group B received IAD therapy using bicalutamide 150 mg once daily in the on-phases and etoricoxib 60 mg once daily in the off-phases.
Results: Median follow-up was 62 weeks. In group A 5 of 22 (22.7%) cases and in group B 2 of 22 (9.1%) cases failed to respond to IAD (P >0.05). Comparing the two groups, in all three cycles of IAD the time of the cycles and the time of the off-phases were significantly (P <0.0001) longer in group B than in group A. The highest PSA value reached during the off-phases in each cycle was significantly (P <0.001) lower in group B than in group A. Withdrawal from treatment owing to side effects was not necessary in any of the 44 patients.
Conclusions: In patients with biochemical progression after RRP, we showed that the use of a COX-2 inhibitor in the off-phases of IAD is able to increase the off-treatment time significantly.