- Degarelix Suppressed Testosterone Within Three Days in 96% of Patients.
Data from a Phase III study presented at the 23rd Annual European Association of Urology Congress demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone (1),(2) within three days in more than 96% of study patients.(2)
The new data show that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery
(orchidectomy).(2),(3)
The phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprorelin's 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer (PCa) patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) significantly faster.
In addition, degarelix was able to sustain these low levels during the entire 12 month study.(2)
By day 3 of the study, testosterone levels were suppressed to less than or equal to 0.5ng/mL in 96.1% of patients in the degarelix arms of the study compared to 0% in the leuprorelin arm. By day 14 100% of patients in the degarelix arms achieved suppression of testosterone levels at less than or equal to 0.5ng/mL compared to 18.2% in the leuprorelin arm.(2)
"Our goal is always to have a fast and sustained reduction in testosterone levels" said Mr John Anderson, Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom.
"This new data shows that degarelix produced an extremely rapid impact, approaching the immediacy of surgery."
After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprorelin saw an 18% decline. Both treatments were well tolerated and showed similar side effect profiles.
"What patients want is a medical treatment which has the efficacy impact of orchidectomy but without its more distressing physical and psychological effects," commented Dr Erik Briers, of patient organisation Europa Uomo, Belgium. "A pharmaceutical treatment that could offer extremely rapid suppression of testosterone would be a very welcome addition to the options for men with prostate cancer."
Degarelix went through an extensive clinical programme of more than 20 studies. All studies have found degarelix to be safe, well tolerated and with no evidence of systemic allergic reactions.(2),(4),(5) |
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