A PILOT PHASE IV STUDY TO EVALUATE VARIATION IN BONE MINERAL DENSITY, LEAN AND FAT BODY MASS MEASURED BY DUAL-ENERGY X-RAY ABSORPTIOMETRY IN PATIENTS WITH PROSTATE CANCER WITHOUT BONE METASTASIS TREATED WITH DEGARELIX
- Conditions
- prostate cancerprostate cancer without bone metastasesMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10036921Term: Prostate carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004210-10-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 35
-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
-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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br>-to assess changes in fasting serum lipids after 12 months of therapy;<br>-to assess changes in bone turn-over markers after 12 months of therapy;<br>-to assess changes in insulin sensitivity after 12 months of therapy;<br>-to assess changes in serum FSH levels after 12 months of therapy;<br>-to correlate changes in serum FSH with changes in body composition.<br><br>;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 Outcome Measures
Name Time Method 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