Login to Access Video or Poster Abstract: MP57-13
Sources of Funding: Clinical trial was funded by Ferring Pharmaceuticals inc. Company does not have access to data.

Introduction

Androgen-deprivation therapy (ADT) used in prostate cancer patients may increase their risk of cardio-vascular events. Recent data suggests that LHRH-antagonist may be associated with lower risk of these events compared to LHRH-agonist. Our laboratory data suggest a role for FSH in mediating ADT induced atherosclerosis. We now report our early cardio-vascular outcome and change in FSH levels from a pilot randomized controlled study.

Methods

A bicenteral randomized open-label study of the use of Degarelix compared to LHRH agonists among prostate cancer patients with pre-existing cardiovascular disease with scheduled to start ADT for at least a year. _x000D_ A Cardiovascular event was considered one of the following: myocardial infarction, ischaemic or haemorrhagic cerebrovascular event, arterial embolic and thrombotic events, emergency room visit or hospitalization due to ischaemic heart disease conditions, coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures(, peripheral vascular disease event (vascular surgery/intervention). These events were prospectively collected. _x000D_ Serum levels for hormonal profile were taken at baseline and every three months. _x000D_

Results

Forty six patients were enrolled (23 randomized to each arm), with a median follow up of 6.3 months. No difference in age, stage of prostate cancer and baseline cardiovascular were observed between the two arms._x000D_ During follow-up six patients developed a new cardio-vascular event. Four of the six patients were hospitalized due to ischemic heart disease, one patient suffered from a myocardial infarction and one from a new ischemic cerebrovascular event. All six patients were randomized to the LHRH-agonist arm of the trial (26%). None of the patients randomized to the Degarelix arm experienced any new cardio-vascular event during follow-up. _x000D_ All patients achieved castrate testosterone levels. FSH decreased from pre-ADT levels by a median of 93% among the Degarelix arm compared to 27% reduction in the agonist arm (p=0.00011). Within the agonist arm, patients with a lower than 30% FSH decrease had a 50% probability of a cardiovascular event, compared to only 12.5% of patients with a higher effect on FSH levels._x000D_

Conclusions

Our pilot study suggests that cardio-vascular events may develop early in patients receiving LHRH-agonist compared to antagonist. These events may be linked to reduce suppression of FSH during ADT.

Funding

Clinical trial was funded by Ferring Pharmaceuticals inc. Company does not have access to data.