prostate cancer prostate cancer without bone metastases MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10036921 Term: Prostate carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: FIRMAGON - 120 MG - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - POLVERE: FLACONCINO (VETRO) SOLVENTE: SIRINGA PRE-RIEMPITA (VETRO) - FLACONCINO POLVERE: 120 MG - SIRI
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
Male
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - patients with absolute or relative contraindication for prescription of Degarelix. In particular: - hypersensitivity towards any component of , patients with allergy to any ingredients in Firmagon® - and patients who receive concomitant medications that might prolong the QT intervalhave a long QT syndrome, in partcolar class IA (suc as quinidine, procainamide, disopyramide,) or class III antiarrhythmics (suc as amiodarone, sotalol, dofetilide, ibutilide) - patients with history of or risk factors for Torsades de Pointes - patients who take either methadone or moxifloxacina or antipsychotic - patients with alteration in or problems with electrolyte blood levels (such as sodium, potassium, calcium and magnesium) - patients with severe or kidney and/or liver problemsdysfunctions; - 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine changes in fat body mass after 12 months Degarelix administration.;Secondary Objective: - to assess changes in lean body mass and bone mineral density after 12 months of therapy; - to assess changes in fasting serum lipids after 12 months of therapy; - to assess changes in bone turn-over markers after 12 months of therapy; - to assess changes in insulin sensitivity after 12 months of therapy; - to assess changes in serum FSH levels after 12 months of therapy; - to correlate changes in serum FSH with changes in body composition. ;Primary end point(s): To compare the mean values (adjusted for baseline T0 values) of changes in fat body mass (after 12 months of therapy, T1) as measured by DXA scan (g/cm2).;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - to compare the adjusted T1 mean values of percentage lean mass and lumbar spine mineral density by DXA scan;; - to compare the adjusted T1 mean values of Body Mass Index (Kg/m2);; - to compare the adjusted T1 mean values of total, HDL and LDL cholesterol and triglycerides as measured by standard automatic procedures;; - to compare the adjusted T1 mean values of alkaline phosphatase (AP) measured as units x liter (UI/L);; - to compare the adjusted T1 mean values of whole body insulin sensitivity index and glycosylated haemoglobin;; - to compare the adjusted T1 mean values of serum FSH levels as measured by commercially available kits;; - univariate and multivariate relationship between changes in serum FSH and changes of FBM, LBM and BMD.;Timepoint(s) of evaluation of this end point: 12 month; 12 month; 12 mesi; 12 month; 12 month; 12 month; 12 month | — |
Countries
Italy
Contacts
Public Contactcoordinamento ricerca
Azienda Ospedaliera Spedali Civili di Brescia
Outcome results
None listed