Prostate Cancer Clinical Trial
Official title:
A Pilot Phase IV Study to Evaluate Variation in Bone Mineral Density, Lean and Fat Body Mass Index Measured by Dual-energy X-ray Absorptiometry in Patients With Prostate Cancer Without Bone Metastasis Treated With Degarelix
The aim of this phase IV interventional study is to evaluate variation in bone mineral density and lean and fat body composition in patients with prostate cancer without bone metastasis, treated with Degarelix. These variations are evaluated at time 0 (before starting androgen deprivation therapy with Degarelix) and after 12 months of therapy by dual-energy X-ray absorptiometry (DXA scan).
Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and
increase fracture risk in men with prostate carcinoma. GnRH agonists also increase fat mass
and decrease lean body mass. These treatment-related changes in body composition may
contribute to fatigue, emotional distress, and decreased quality of life. Whereas the
consequences of initial GnRH agonist on BMD and body composition are well characterized,
less is known regarding the effects of GnRH antagonists. At the best of our knowledge the
changes in body composition induced by Degarelix in prostate cancer patients has never been
explored. Dual-energy X-ray absorptiometry (DXA) is a reliable and accurate method to
determine the changes in body composition in patients with prostate cancer (PCa) undergoing
androgen deprivation therapy (ADT).
The change in body composition is a major determinant of increased morbidity and mortality
induced by ADT and DXA provides the most precise measure of body composition. This study is
designed to obtain explorative information on changes in bone mineral density, fat body mass
and lean body mass by DXA scan after administration of Degarelix. These preliminary data
compared with historical data of patients submitted to GnRH agonists could provide a
rationale for a subsequent prospective randomized clinical trial.
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