E. David Crawford, MD, from the University of Colorado, Anschutz Medical Campus, discusses research that led to the 2008 approval of degarelix as a treatment for men with prostate cancer.
E. David Crawford, MD, professor in Surgery and Radiation Oncology and the head of Urologic Oncology at the University of Colorado, Anschutz Medical Campus, discusses research that led to the 2008 approval of degarelix as a treatment for men with prostate cancer.
In the pivotal study, 610 patients were randomized to receive androgen-deprivation therapy with degarelix or leuprolide. The study examined three treatment strategies. For degarelix, patients received a 240 mg subcutaneous loading dose followed by monthly maintenance therapy at 80 mg or 160 mg. For leuprolide, a 7.5 mg monthly dose was administered. The primary endpoint of suppression of testosterone levels was similar between all three dosing strategies, at the end of one year, notes Crawford.
Looking at other endpoints, the median PSA level in the degarelix groups was significantly lower than the leuprolide arm. Furthermore, Crawford notes, treatment with degarelix did not result in a testosterone flare event.
Interestingly, Crawford notes, follicle-stimulating hormone (FSH) levels were found to be higher in the leuprolide arm of the trial than with degarelix. Additionally, FSH was higher in patients treated with orchiectomy. In some situations, Crawford says, the FSH receptor is selectively expressed on the surface of blood vessels in tumors and may promote tumor growth. As a result, lowering this hormone could impact the recurrence of prostate cancer, Crawford suggests.