Safety and efficacy of exisulind for treatment of recurrent prostate cancer after radical prostatectomy.
OBJECTIVE
We evaluated the safety and efficacy of exisulind for delaying disease progression in men with increasing prostate specific antigen (PSA) after radical prostatectomy.


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 difference in change from baseline PSA between the placebo and exisulind groups. The PSA doubling time was also evaluated before and during study. A subgroup analysis classified patients based on the risk of developing metastatic disease.


RESULTS
Compared with placebo, exisulind significantly suppressed the increase in PSA in all patients (p = 0.017). The results were also statistically 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, median 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 results suggest that Exisulind has the potential to extend the time from biochemical recurrence to the need for androgen deprivation therapy. Exisulind was well tolerated in this patient population. Our results support further study of Exisulind in the treatment of patients with prostate cancer.
Goluboff
E T
ET
Department of Urology, Columbia University, Columbia-Presbyterian Medical Center, Allen Pavilion, 5141 Broadway, New York, NY 10034, USA.
Prager
D
D
Rukstalis
D
D
Giantonio
B
B
Madorsky
M
M
Barken
I
I
Weinstein
I B
IB
Partin
A W
AW
Olsson
C A
CA
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D011183:Postoperative Complications / Q000453:epidemiology; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000601:surgery*; D013467:Sulindac / Q000031:analogs & derivatives / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D013467:Sulindac; D017430:Prostate-Specific Antigen; C025463:sulindac sulfone