Clinical Trials Register

Summary
EudraCT Number:	2018-001034-18
Sponsor's Protocol Code Number:	PETMR-Staging-PCa1
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:	2018-11-05
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

2018-001034-18

A.3

Full title of the trial

Phase II monocentric study to evaluate a novel approach for staging prostate cancer patients by using a fully integrated hybrid PET/MRI

Studio monocentrico di Fase II per valutare un approccio innovativo per la stadiazione del paziente con carcinoma prostatico con l’utilizzo della tecnica ibrida PET/RM

A.3.1

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

Study on patients with prostate cancer with the PET/MR

Studio su pazienti con tumore alla prostata con la metodica PET/RM

A.3.2

Name or abbreviated title of the trial where available

PETMR-Staging-PCa1

A.4.1

Sponsor's protocol code number

PETMR-Staging-PCa1

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	OSPEDALE SAN RAFFAELE
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	AIRC
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Ministero della Salute
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	IRCCS Ospedale San Raffaele
B.5.2	Functional name of contact point	Medicina Nucleare
B.5.3	Address:
B.5.3.1	Street Address	Via Olgettina 60
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	0226437053
B.5.5	Fax number	0226432717
B.5.6	E-mail	incerti.elena@hsr.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	No
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	68GA-PSMA-HBED-CC
D.3.2	Product code	[68GA-PSMA-HBED-CC]
D.3.4	Pharmaceutical form	Solution for injection
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	PSMA-HBED-CC (PSMA-11)
D.3.9.2	Current sponsor code	68Ga-PSMA
D.3.9.3	Other descriptive name	68Ga-PSMA
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	110 to 210
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	Yes
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	No
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	68GA-DOTA-RM2
D.3.2	Product code	[68GA-DOTA-RM2]
D.3.4	Pharmaceutical form	Solution for injection
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	DOTA-RM2 ACETATO
D.3.9.2	Current sponsor code	DOTA-RM2 ACETATO
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	90 to 190
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	Yes
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

Patient diagnosed with prostatic carcinoma

Paziente con diagnosi di carcinoma prostatico

E.1.1.1

Medical condition in easily understood language

Patient with prostate cancer

Paziente con carcinoma della prostata

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	10026389
E.1.2	Term	Malignant neoplasm of prostate
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

Evaluate a new diagnostic and innovative approach for the staging of prostate cancer with the use of the recently introduced PET/MR imaging method and new tracers (68Ga-PSMA and 68Ga-Bombesina).

Valutare un nuovo approccio diagnostico ed innovativo per la stadiazione del tumore prostatico con l’utilizzo della metodica di imaging di recente introduzione PET/RM e nuovi traccianti (68Ga-PSMA e 68Ga-Bombesina).

E.2.2

Secondary objectives of the trial

- Optimize the image acquisition and analysis protocol of the innovative PET/MR methodology in order to offer an optimal approach.
- Characterize the phenotype of the prostatic primary tumor using: 1) hybrid PET/MR imaging with 68Ga-PSMA and 68Ga-Bombesin tracers, 2) multiparametric MRI (mp-MR) techniques; and 3) integrated radiomal analysis with clinical, histopathological and cellular markers of tumor aggression based on peripheral blood particle counts and biochemical, clinical and instrumental follow-up.
- Evaluate the stability / reproducibility of the radiomic analysis on mp-MR data for the characterization of the tumor by a testretest procedure.
- Define the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina and with state-of-the-art mp-MR staging techniques (T, N and M).
- Evaluate the impact of PET/MR with 68Ga-PSMA and 68Ga-Bombesina in the choice of therapeutic strategies and clinical management of the patient.

- Ottimizzare il protocollo di acquisizione e di analisi delle immagini della metodica innovativa PET/RM al fine di offrire un approccio ottimale.
- Caratterizzare il fenotipo del tumore primitivo prostatico utilizzando: 1) imaging ibrido PET/RM con i traccianti 68Ga-PSMA e 68Ga-Bombesina, 2) tecniche di RM multiparametrica (mp-RM); e 3) analisi radiomica integrata con marcatori clinici, istopatologici e cellulari di aggressività tumorale basati sulla conta di particelle nel sangue periferico e sul follow-up biochimico, clinico e strumentale.
- Valutare la stabilità/riproducibilità dell’analisi radiomica sui dati mp-RM per la caratterizzazione del tumore mediante procedura test-retest.
- Definire l’accuratezza diagnostica della PET/RM con 68Ga-PSMA e 68Ga-Bombesina e con le tecniche mp-RM allo stato dell’arte nella stadiazione (T, N e M).
- Valutare l’impatto della PET/RM con 68Ga-PSMA e 68Ga-Bombesina nella scelta delle strategie terapeutiche e gestione clinica del paziente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age = 18 years
2. Diagnosis of prostate cancer proven by biopsy
3. Informed informed consent

1. Età = 18 anni
2. Diagnosi di tumore alla prostata comprovata dalla biopsia
3. Consenso informato firmato

E.4

Principal exclusion criteria

1. Age less than 18 years
2. Inability to complete required imaging tests (eg severe claustrophobia)
3. Any other medical condition that may interfere with study compliance
4. All contraindications for MRI (eg pace-maker)
5. Evidence of metastatic disease to conventional imaging that would contraindicate the surgical procedure

1. Età inferiore a 18 anni
2. Incapacità di completare gli esami di imaging richiesti (es. severa claustrofobia)
3. Qualunque altra condizione medica che possa interferire con la compliance dello studio
4. Tutte le controindicazioni per RM (es. pace-maker)
5. Evidenza di malattia metastatica all’imaging convenzionale che controindicherebbe la procedura chirurgica

E.5 End points

E.5.1

Primary end point(s)

Evaluation of the staging of patients with prostate cancer using PET / MR hybrid imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina) and
tumor biomarkers.

Valutazione della stadiazione dei pazienti con tumore prostatico mediante imaging ibrido PET/RM con radiofarmaci innovativi (68Ga-PSMA e 68Ga-Bombesina) e biomarcatori tumorali.

E.5.1.1

Timepoint(s) of evaluation of this end point

60 months

60 mesi

E.5.2

Secondary end point(s)

- Optimization of the PET/MR acquisition protocol with 68Ga-PSMA and 68Ga-Bombesina for the staging of the patient with prostate tumor.; Characterization of the tumor phenotype with imaging and histopathological data.; - Definition of the stability/reproducibility of the radiomic analysis.; - Evaluation of the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina.

- Ottimizzazione del protocollo di acquisizione PET/RM con 68Ga-PSMA e 68Ga-Bombesina per la stadiazione del paziente con tumore prostatico.; - Caratterizzazione del fenotipo tumorale con i dati di imaging ed istopatologici.; - Definizione della stabilità/riproducibilità dell’analisi radiomica.; - Valutazione dell’accuratezza diagnostica della PET/RM con 68Ga-PSMA e 68Ga-Bombesina.

E.5.2.1

Timepoint(s) of evaluation of this end point

60 months; 60 months; 60 months; 60 months

60 mesi; 60 mesi; 60 mesi; 60 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

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)

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

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

In aperto

Open

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.8.6 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

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)

AT THE END OF CLINICAL EXPERIMENTATION (execution of PET/MR study with 68Ga-PSMA and 68Ga-Bombesina) PATIENTS WILL CONTINUE THE CLINICAL ITER INTENDED FOR THEIR PATHOLOGY.

AL TERMINE DELLA SPERIMENTAZIONE CLINICA (esecuzione studio PET/RM con 68Ga-PSMA e 68Ga-Bombesina) I PAZIENTI PROSEGUIRANNO L’ITER CLINICO PREVISTO PER LA LORO PATOLOGIA.

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

2020-02-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-03-04

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

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