Safety and efficacy of exisulind for treatment of recurrent prostate cancer after radical prostatectomy

Purpose: We evaluated the safety and efficacy of exisulind for delaying dis ease progression in men with increasing prostate specific antigen (PSA) aft er radical prostatectomy. Materials and Methods: A total of 96 men with increasing PSA after radical prostatectomy were randomized to receive placebo (49) or 250 mg. exisulind twice daily (47) for 12 months. The primary efficacy parameter was the diff erence in change from baseline PSA between the placebo and exisulind groups . The PSA doubling time was also evaluated before and during study. A subgr oup analysis classified patients based on the risk of developing metastatic disease. Results: Compared with placebo, exisulind significantly suppressed the incr ease in PSA in all patients (p = 0.017). The results were also statisticall y significant in men at high risk for metastasis (p = 0.0003) and those who could not be classified according to risk (p = 0.0009). In addition, media n PSA doubling time was lengthened in high risk patients on exisulind (2.12 month increase) compared with those on placebo (3.37 month decrease, p = 0 .048). Exisulind was well tolerated. Conclusions: Exisulind inhibited the increase in PSA overall and prolonged PSA doubling time in high risk patients compared with placebo. These result s suggest that Exisulind has the potential to extend the time from biochemi cal recurrence to the need for androgen deprivation therapy. Exisulind was well tolerated in this patient population. Our results support further stud y of Exisulind in the treatment of patients with prostate cancer.