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

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Spedali Civili di Brescia; Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborator: Ferring Pharmaceuticals

Criteria

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;