Clinical Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

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Study Overview

Prostate cancer is a common disease among men. The risk of getting prostate cancer increases with age. In many prostate cancers, a hormone in the body (testosterone) causes cancer cells to grow. Lowering the amount of testosterone can help reduce cancer growth and its spread. Current medical treatment involves using medication to lower the testosterone levels. This method s called “androgen deprivation” and there are two different types of medication generally used for his purpose. 


One type is called gonadotropin releasing hormone antagonists (GnRH Receptor Antagonists) and another is called gonadotropin releasing hormone agonists (GnRH Receptor Agonists). This research trial is only for those individuals for whom it has been clinically determined that androgen deprivation therapy is the most appropriate. Androgen deprivation is associated with a number of side effects, such as sexual dysfunction (inability to have or enjoy sexual intercourse), hot flashes, osteoporosis (brittle bones) and metabolic changes that can lead to atherosclerosis (hardening of the blood vessels).  Research trials have consistently shown that if you have a pre- xisting cardiovascular disease, you are more likely to experience cardiovascular complications during androgen deprivation therapy. This research trial is to assess whether that are differences in risk of cardiovascular complications between one marketed drug for advanced prostate cancer (FIRMAGON) and another marketed drug or advanced prostate cancer (LUPRON DEPOT; hereafter denoted LUPRON) in patients with both prostate cancer and cardiovascular disease. Both FIRMAGON and LUPRON are approved for marketing by the U.S. Food and Drug Administration (FDA).

Study Description

If you qualify for the trial, you will be randomly assigned by chance (like the flip of a coin) to receive one of the two treatments, i.e. either FIRMAGON or LUPRON, for a period of 12 months. You have equal chance of receiving one of the two possible treatments. Assignment of treatment will be done at Visit 2. Please advise that the implications of study randomization eliminate patient-physician choice of the type of treatment.
FIRMAGON is given by injection under the skin of the belly. If you are selected to receive FIRMAGON you will receive a total of 12 doses; the first dose as two injections as a starting dose of 240 mg degarelix at a concentration of 40 mg/mL, and the next 11 doses as maintenance doses of 80 mg degarelix at a concentration of 20 mg/mL will each be given as one injection at monthly intervals starting one month after the first dose has been administered.
The comparator treatment, LUPRON, is given by injection into muscles of the thigh, the shoulder or the buttocks, and the injection site can be alternated. If you are assigned to receive LUPRON, you will receive a total of 4 doses; one injection every 3 months of 22.5 mg each.

  • Study Identifier: 832106

Recruitment Status

Open

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