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Degarelix DTC Summary LTHT Drug and Therapeutics Committee Summary Degarelix For symptomatic, advanced metastatic high PSA prostate cancer patients at risk of impending spinal cord compression or urinary obstruction Supported for use in a specific group of patients NHS Leeds Traffic Light Classification: RED Application summary - March 2012 • Degarelix injection is a gonadotropin-releasing hormone (GnRH) antagonist. It induces a rapid and sustainable decrease in both testosterone and prostate specific antigen (PSA) levels without an initial testosterone surge after administration. • Licensed for the treatment of adult male patients with advanced hormone dependant prostate cancer. At LTH it will be used in those adult patients who have symptomatic, advanced metastatic, high PSA prostate cancer who are at risk of impending spinal cord compression or urinary obstruction (this is a licensed use). • Patients will only receive degarelix as an inpatient. It is estimated patients will receive no more than 1-3 doses before being converted to a suitable alternative, leuprorelin/goserelin. • The pivotal trial is a phase III open label study in 610 men with histologically confirmed prostate cancer. This compared two different doses of degarelix with leuprorelin. Clinical flare protection with bicalutamide was given to patients in the leuprorelin group at the discretion of the investigator. In addition, the non-inferiority of degarelix versus leuprorelin acetate in achieving and maintaining castrate levels of testosterone was demonstrated. • The EMA acknowledges that the major clinical added value of degarelix was the avoidance of the testosterone flare seen with LHRH agonists (in other words, no requirement for concomitant anti-androgen therapy), and they note that degarelix is thus especially useful when a rapid reduction in the testosterone levels is of critical importance. The European Association of Urology (EAU) current guidelines on Prostate Cancer comment that the clinical advantage of suppression of the initial flare-up is only clinically relevant in a minority of metastatic patients, for example in patients with impending spinal cord compression. • Safety - The proportions of patients with treatment-emergent adverse events (AE) were comparable across the treatment groups. • It is anticipated that 5-10 patients per year would be treated with degarelix. • In patients presenting with newly diagnosed prostate cancer with actual or imminent spinal cord compression or obstructive uropathy not suitable for surgical orchidectomy, degarelix (by providing immediate reduction in testosterone rather than the 4-6 weeks for current LHRH agonists), will reduce the risk of paraplegia or significant kidney failure. These are catastrophic events for patients and reduce survival significantly. Place in therapy Symptomatic, advanced metastatic, high PSA prostate cancer patients who are at risk of impending spinal cord compression or urinary obstruction. Drug and Therapeutics Decision Summary - March 2012 A summary of the evidence was presented at the meeting. There are some limitations of the study including the dose of leuprorelin used which is not a dose used in practice. Degarelix has demonstrated non-inferiority to alternative agents with potential benefits. The question of LHRH plus bicalutamide being equivalent to degarelix was raised. The use is for those who present with severe disease, for example presenting with leg weakness, obstructive uropathy or renal failure. Ideally these patients would be given an orchidectomy, however there is a cohort who are not fit for general anaesthesia. The advantage of degarelix is that provides immediate castration levels of testosterone compared with 4-6 weeks required for alternative therapies. The proposal is that patients will be on Degarelix for 2 months and then transferred to Goserelin (Zoladex®). • Supported for initial treatment of a specific group of patients by consultants in urology, clinical and medical oncology. Compiled from the original formulary application and the Drug and Therapeutics Committee minutes Dave Abbott, Senior Medicines Information Pharmacist The Leeds Medicines Information Service [email protected] .
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