Clinical Trials Register

Summary
EudraCT Number:	2016-004210-10
Sponsor's Protocol Code Number:	ASSTBS-BLADE-2540-2016
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004210-10

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

studio pilota di fase 4 non randomizzato per la valutazione delle variazioni della densit¿ minerale ossea e della massa magra e grassa misurate con assorbimetria a raggi x a doppia energia in pazienti con tumore prostatico senza metastasi ossee in terapia con Degarelix

A.3.2

Name or abbreviated title of the trial where available

BLADE

A.4.1

Sponsor's protocol code number

ASSTBS-BLADE-2540-2016

A.5.4

Other Identifiers

Name:

BLADE

Number:

ASSTBS-BLADE-2540-2016

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ferring S.p.A
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliera Spedali Civili di Brescia
B.5.2	Functional name of contact point	coordinamento ricerca
B.5.3	Address:
B.5.3.1	Street Address	p.le Spedali Civili 1
B.5.3.2	Town/ city	brescia
B.5.3.3	Post code	25124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0303996851
B.5.5	Fax number	0303996125
B.5.6	E-mail	coordinamento.ricerca@ASST-spedalicivili.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	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 - SIRINGA PRE-RIEMPITA SOLVENTE: 3 ML 2 FLACONCINI+2 SIRINGHE PRE-RI
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRING PHARMACEUTICALS A/S
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	firmagon
D.3.2	Product code	firmagon
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	214766-78-6
D.3.9.2	Current sponsor code	214766-78-6
D.3.9.3	Other descriptive name	DEGARELIX
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	80 to 240
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

prostate cancer

prostate cancer without bone metastases

carcinoma della prostata, senza metastasi ossee

E.1.1.1

Medical condition in easily understood language

prostate cancer

prostate cancer without bone metastases

carcinoma della prostata, senza metastasi ossee

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10060862
E.1.2	Term	Prostate cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10036921
E.1.2	Term	Prostate carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine changes in fat body mass after 12 months Degarelix administration.

Determinare la variazione della massa grassa corporea dopo 12 mesi di terapia con Degarelix

E.2.2

Secondary objectives of the trial

- 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.

- Determinare la variazione della massa magra e della densit¿ minerale ossea dopo 12 mesi di terapia;
- determinare la variazione del profilo lipidico dopo 12 mesi di terapia;
- determinare la variazione dei markers di turn over osseo dopo 12 mesi di terapia;
- determinare la variazione di sensibilit¿ all¿insulina dopo 12 mesi di terapia;
- determinare la variazione dei livelli sierici di FSH dopo 12 mesi di terapia;
- correlare le variazioni dei livelli di FSH con quelle corporee.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

- pazienti di sesso maschile, di età uguale o maggiore di 18 anni, disposti e in grado di fornire il consenso informato scritto;
- diagnosi istologica di carcinoma prostatico;
- più di 6 mesi prospettiva di sopravvivenza;
- nessun metastasi ossee valutata mediante scintigrafia ossea;
- idoneità ad ADT con Degarelix a giudizio dello sperimentatore clinico.

E.4

Principal 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;

- Pazienti con controindicazione assoluta o relativa per la prescrizione di Degarelix. In particolare:
- Ipersensibilità verso qualsiasi componente di, pazienti con allergia a qualsiasi ingredienti in Firmagon®
- Ed i pazienti che ricevono farmaci concomitanti che potrebbero prolungare il QT intervalhave una sindrome del QT lungo, in classe partcolar IA (suc come chinidina, procainamide, disopiramide,) o III antiaritmici di classe (CUS come amiodarone, sotalolo, dofetilide, ibutilide)
- pazienti con storia di o fattori di rischio per torsione di punta
- i pazienti che assumono metadone o moxifloxacina o antipsicotico
- pazienti con alterazione o problemi con livelli ematici elettrolita (come sodio, potassio, calcio e magnesio)
- i pazienti con problemsdysfunctions gravi o renali e / o epatici;
- Malattia metabolica dell'osso concomitante, come la malattia di Paget, l'iperparatiroidismo primario o ipercortisolismo cronico, come registrato dalla storia medica;
- Insufficienza renale (creatinina sierica al basale superiore a 1,5 mg / dl);
- Trattamento ormonale precedente;
- Trattamento precedente o concomitante con bifosfonati o altri farmaci noti per influenzare il metabolismo osseo (per esempio steroidi, calcitonina);

- pazienti che partecipano a un trial clinico interventistico in cui è previsto un trattamento e un follow-up.

E.5 End points

E.5.1

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).

Confrontare i valori medi (corretti per i valori basali, T0) dei cambiamenti di massa grassa corporea (dopo 12 mesi di terapia, T1) con DXA scan (g/cm2)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

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.

- Confrontare il T1 pesato dei valori medi di percentuale di massa magra e di densit¿ minerale ossea della colonna vertebrale lombare mediante DXA scan; - confrontare il T1 pesato dei valori medi di Indice di Massa Corporea (Kg/m2);; - confrontare il T1 pesato dei valori medi del colesterolo totale, HDL e LDL e dei trigliceridi; - confrontare il T1 pesato dei valori medi della fosfatasi alcalina (AP) misurata come unit¿ x litro (UI/L);; - confrontare il T1 pesato dei valori medi di sensibilit¿ all'insulina e di emoglobina glicata;; - confrontare il T1 pesato dei valori medi dei livelli di FSH sierici;; - analisi univariata e multivariata tra le variazioni di FSH sierico e densit¿ minerale ossea e massa corporea grassa e magra

E.5.2.1

Timepoint(s) of evaluation of this end point

12 month; 12 month; 12 mesi; 12 month; 12 month; 12 month; 12 month

12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

patients continue treatment after the conclusion of the study until it is the optimal therapy for the patient

i pazienti continueranno il trattamento dopo la conclusione dello studio finch¿ ¿ la terapia ottimale per il paziente

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-02-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-29

P. End of Trial
P.	End of Trial Status	Completed

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