The results of a clinical study demonstrating that exisulind (Aptosyn) slows tumor growth in men with advanced prostate cancer was published in the September 2001 issue of The Journal of Urology. The study is the first to show the significant effect of this new class of drugs that may stabilize progressive, recurrent disease in patients with advanced prostate cancer. Previous studies in mice showed that exisulind inhibited the growth of prostate cancer by 80% to 90%.
"These results suggest that exisulind may delay disease progression in men with recurrent prostate cancer," said Dr. Erik Goluboff, assistant professor of urology at Columbia University College of Physicians and Surgeons, director of urology at The Allen Pavilion of New York-Presbyterian Hospital, and the principal investigator of the trial. "This will subsequently prolong the time period between postsurgical PSA rise and the need for androgen deprivation therapies."
PSA Levels Stabilized
For 12 months, the trial followed 96 prostate cancer patients who already had their prostate glands removed. All had rising prostate-specific antigen (PSA) levels indicating recurrent disease. Half received exisulind, and half were given a placebo. The researchers measured the drug’s ability to slow or halt disease progression by following patient’s PSA levels.
Imaging tests were performed before and after the study, which was funded by Cell Pathways Inc, developer of the drug. All the men were classified into risk groups with no statistical difference in age, race, and weight. The study showed a significant decrease in the rate at which PSA levels rose in patients given exisulind compared with placebo. However, Dr. Goluboff cautioned that more research needs to be conducted to determine the long-term effects in these patients and in other groups of patients with prostate cancer.