Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix (BLADE)

This is an interventional other trial for Prostate Cancer focused on measuring Androgen deprivation therapy, GnRH antagonist Read More

Inclusion Criteria:

• male outpatients, aged 18 or older, willing and able to provide written informed consent;
• histological diagnosis of prostate carcinoma;
• more than 6-month survival prospect;
• no bone metastases as assessed by bone scintigraphy;
• eligibility to ADT with Degarelix in the opinion of the clinical investigator.

Exclusion Criteria:

• patients with absolute or relative contraindication for prescription of Degarelix. In particular:
• hypersensitivity towards any component of Firmagon®
• patients who receive concomitant medications that might prolong the QT interval, in particular class I A (such as quinidine, procainamide, disopyramide,) or class III antiarrhythmics (such as amiodarone, sotalol, dofetilide, ibutilide)
• patients with history of or risk factors for Torsades de Pointes
• patients who take either methadone or moxifloxacin or antipsychotic
• patients with alteration in electrolyte blood levels (such as sodium, potassium, calcium and magnesium)
• patients with severe kidney and/or liver dysfunctions;
• concomitant bone metabolic disease, such as Paget's disease, primary hyperparathyroidism or chronic hypercortisolism, as recorded by medical history;
• renal failure (baseline serum creatinine more than 1.5 mg/dl);
• prior hormonal treatment;
• prior or concomitant treatment with bisphosphonates or other drugs known to affect bone metabolism (for example steroids, calcitonin);
• patients participating in an interventional clinical trial in which any treatment or follow-up is mandated;