Clinical Trials Register

Summary
EudraCT Number:	2017-000305-21
Sponsor's Protocol Code Number:	ASCB-Onco-2336-2017
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-05
Trial 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

2017-000305-21

A.3

Full title of the trial

Assessment of bone response after LHRH-A and Enzalutamide plus minus Zoledronic Acid in prostate cancer patients with hormone sensitive metastatic bone disease: a prospectic, phase II, randomized, multicenter study”.

VALUTAZIONE DELLA RISPOSTA OSSEA DOPO LHRH-ANALOGO IN ASSOCIAZIONE AD ENZALUTAMIDE CON O SENZA ACIDO ZOLEDRONICO IN PAZIENTI CON METASTASI OSSEE DA CARCINOMA PROSTATICO ORMONO SENSIBILE: STUDIO PROSPETTICO DI FASE II RANDOMIZZATO MULTICENTRICO

A.3.1

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

VALUTAZIONE DELLA RISPOSTA OSSEA DOPO LHRH-ANALOGO IN ASSOCIAZIONE AD ENZALUTAMIDE CON O SENZA ACIDO

A.3.2

Name or abbreviated title of the trial where available

BONENZA

A.4.1

Sponsor's protocol code number

ASCB-Onco-2336-2017

A.5.4

Other Identifiers

Name:

Bonenza

Number:

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	Astellas Pharma Europe LTD
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	asst spedali civili di brescia
B.5.2	Functional name of contact point	coordinamento ricerca clinica
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	25123
B.5.3.4	Country	Italy
B.5.4	Telephone number	03039951
B.5.5	Fax number	03039951
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	Comparator
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	XTANDI - "40 MG - CAPSULA MOLLE - USO ORALE - BLISTER (PVC/PCTFE/ALU)" 112 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA EUROPE B.V.
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	ENZALUTAMIDE
D.3.2	Product code	[ENZALUTAMIDE]
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ENZALUTAMIDE
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
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.IMP: 2
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	ACIDO ZOLEDRONICO MYLAN - 4 MG/5 ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	MYLAN S.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	acido zoledronico
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACIDO ZOLEDRONICO
D.3.9.1	CAS number	118072-93-8
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	ENANTONE - 3.75 MG/ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE 1 SIRINGA PRE-RIEMPITA A DOPPIA CAMERA CON POLVERE E SOLVENTE
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA ITALIA S.P.A.
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	leuprorelina
D.3.2	Product code	[na]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPRORELINA ACETATO
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	ENANTONE - 11.25 MG/ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE 1 SIRINGA PRE-RIEMPITA A DOPPIA CAMERA CON POLVERE E SOLVENTE
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA ITALIA S.P.A.
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	leuprorelina
D.3.2	Product code	[na]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPRORELINA ACETATO
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	11
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.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
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	ELIGARD - 22.5 MG POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 KIT CON 1 SIRINGA PRERIEMPITA POLVERE + 1 SIRINGA PRERIEMPITA SOLVENTE
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA S.P.A.
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	leuprorelina
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPRORELINA ACETATO
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	23
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.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
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	ELIGARD - 7.5 MG POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 KIT CON 1 SIRINGA PRERIEMPITA POLVERE + 1 SIRINGA PRERIEMPITA SOLVENTE
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA S.P.A.
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	leuprorelina
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPRORELINA ACETATO
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7
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.IMP: 7
D.1.2 and D.1.3	IMP Role	Comparator
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	DECAPEPTYL - 11.25 MG/2 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE A RILASCIO PROLUNGATO 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE + 1 SIRINGA
D.2.1.1.2	Name of the Marketing Authorisation holder	IPSEN S.P.A
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	triptorelina
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	triporelina
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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 with hormone sensitive metastatic bone disease

METASTASI OSSEE DA CARCINOMA PROSTATICO ORMONO SENSIBILE

E.1.1.1

Medical condition in easily understood language

prostate cancer with hormone sensitive metastatic bone disease

METASTASI OSSEE DA CARCINOMA PROSTATICO ORMONO SENSIBILE

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10036927
E.1.2	Term	Prostate neoplasia
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of bone response to Enzalutamide treatment with or without Zoledronic Acid in combination with LHRH-A treatment through Whole-body Diffusion MRI.

Valutazione dell’attività di LHRH analogo ed enzalutamide con o senza acido zoledronico in termini di risposta ossea valutata con Whole body diffusion MRI nei pazienti affetti da metastasi ossee da carcinoma della prostata ormono-sensibile.

E.2.2

Secondary objectives of the trial

• Evaluation of bone repair by CT Scan,
• Change of bone metabolism's markers,
• Changes in bone mineral density and in fat and lean body mass with DEXA scan,
• Changes in bone pain (in patients with bone pain at baseline),
• SREs evaluation,
• Changes in Quality of Life (QoL),
• Progression-free survival,
• Overall survival.

Valutazione della riparazione ossea con TC scan
Modificazione dei markers di metabolismo osseo
Valutazione delle modificazioni della densità minerale ossea, della massa grassa e della massa magra, misurate con DEXA scan
Modificazioni nel dolore osseo (nei pazienti con dolore osseo alla valutazione basale)
Valutazione degli eventi scheletrici correlati (SRE)
Modificazioni nella qualità di vita (QoL)
Sopravvivenza libera da progressione

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: VALUTAZIONE DELL’ESPRESSIONE DI ARV7 SULLE CELLULE TUMORALI CIRCOLANTI AL BASALE E A PROGRESSIONE DI MALATTIA IN UN SOTTOGRUPPO DI 40 PAZIENTI ARRUOLATI NELLO STUDIO BONENZA v. 1 del 10/7/2017

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: VALUTAZIONE DELL’ESPRESSIONE DI ARV7 SULLE CELLULE TUMORALI CIRCOLANTI AL BASALE E A PROGRESSIONE DI MALATTIA IN UN SOTTOGRUPPO DI 40 PAZIENTI ARRUOLATI NELLO STUDIO BONENZA v. 1 del 10/7/2017

E.3

Principal inclusion criteria

1. Histological diagnosis of prostate carcinoma,
2. Age > 18 years,
3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at CT/RMN,
4. No previous hormone or chemotherapeutic treatments given for prostate carcinoma (patients that are receiving LHRH-A therapy for less than 4 months are admitted),
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 1,
6. Expected life expectancy = 6 months,
7. Subject capable to swallow the Study's medication and to comply with the Study's requirements,
8. Signed informed consent.

1. Diagnosi istologica di carcinoma prostatico
2. Età >18 anni
3. Malattia metastatica documentata come presenza di lesioni ossee alla scintigrafia ossea associate o meno a lesioni ai tessuti molli misurabili alla TC/RMN
4. Nessun precedente trattamento ormonale né chemioterapico effettuato per il carcinoma prostatico. Sono ammessi i pazienti in terapia con LHRH-A da meno di 4 mesi
5. Eastern Cooperative Oncology Group (ECOG) performance status di 0–1
6. Aspettativa di vita stimata = 6 mesi
7. Soggetto in grado di inghiottire il farmaco in studio e di attenersi ai requisiti previsti dallo studio
8. Consenso informato scritto firmato

E.4

Principal exclusion criteria

1. Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make (at the discretion of the clinical Investigator),
2. Known or suspected brain metastases or active leptomeningeal dissemination,
3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x ULN at Screening Visit,
6. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit,
7. Albumin = 30 g/L (= 3,0 g/dL) at Screening Visit,
8. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
9. Clinically significant cardiovascular disease including:

1. Presenza di patologia grave in atto, infezione attiva o comorbilità che, a giudizio dello sperimentatore, possa rendere il paziente non arruolabile nello studio
2. Metastasi cerebrale nota o sospetta, o patologia leptomeningea attiva
3. Storia di altra neoplasia maligna nei precedenti 5 anni, diversa dal carcinoma cutaneo non-melanoma
4. Valore assoluto dei neutrofili (ANC) < 1.500/µL, piastrine < 100,000/µL, oppure emoglobina < 5,6 mmol/L (<9 g/dL) alla visita di Screening (NB: ai pazienti non deve essere stato somministrato alcun fattore di crescita nei 7 giorni precedenti né alcuna trasfusione di sangue nei 28 giorni precedenti il prelievo per ematologia eseguito in occasione dello Screening)
5. Bilirubina totale, alanina aminotransferasi (ALT) oppure aspartato aminotransferasi (AST) > 2,5 x ULN alla visita di Screening
6. Creatinina > 177 µmol/L (> 2 mg/dL) alla visita di Screening
7. Albumina = 30 g/L (= 3.0 g/dL) alla visita di Screening
8. Storia di convulsioni o di qualsiasi patologia predisponente alle convulsioni; storia di perdita di coscienza o attacco ischemico transitorio nei 12 mesi precedenti lo Screening
9. Patologia cardiovascolare clinicamente significativa,

E.5 End points

E.5.1

Primary end point(s)

Evaluation of bone response to Enzalutamide treatment with or without Zoledronic Acid in combination with LHRH-A treatment through Whole-body Diffusion MRI.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 4 6 9 12 18 months

2 mesi 4 mesi 6 mesi 9 mesi 12 mesi 18 mesi

E.5.2

Secondary end point(s)

Evaluation of bone repair by CT Scan,
• Change of bone metabolism's markers,
• Changes in bone mineral density and in fat and lean body mass with DEXA scan,
• Changes in bone pain (in patients with bone pain at baseline),
• SREs evaluation,
• Changes in Quality of Life (QoL),
• Progression-free survival,
• Overall survival.

E.5.2.1

Timepoint(s) of evaluation of this end point

2 4 6 9 12 18 months

2 mesi 4 mesi 6 mesi 9 mesi 12 mesi 18 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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

disease progression

progressione clinica di malattia

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:

100

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

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 will be treated with the best therapy available at the SSN

i pazienti saranno trattati con la migliore opzione terapeutica disponibile a carico del SSN

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

2017-10-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-25

P. End of Trial
P.	End of Trial Status	Ongoing

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