Clinical Trials Register

Summary
EudraCT Number:	2018-001036-21
Sponsor's Protocol Code Number:	PCaRestaging-PET/MR
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:	2018-11-06
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

2018-001036-21

A.3

Full title of the trial

Phase II monocentric study on prostate cancer restaging using PET/MR with innovative radiotracers

Studio monocentrico di fase II sulla ristadiazione del carcinoma prostatico mediante utilizzo della PET/MR con traccianti innovativi

A.3.1

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

Study on patients with recurrence of prostate cancer with PET/MR

Studio su pazienti con recidiva di tumore prostatico con PET/MR

A.3.2

Name or abbreviated title of the trial where available

PCa Restaging- PET/MR

A.4.1

Sponsor's protocol code number

PCaRestaging-PET/MR

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	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

Radically treated patient for prostate cancer presenting a biochemical recurrence of disease (PSA: > o = 0.2 ng/mL)

Paziente trattato radicalmente per carcinoma prostatico che presenti una ripresa biochimica di malattia (PSA: > o = 0.2 ng/mL)

E.1.1.1

Medical condition in easily understood language

Patient with prostate cancer treated with increase in PSA during restaging

Paziente con carcinoma della prostata trattato con aumento del PSA in fase di ristadiazione

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

Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina).

Fornire un approccio innovativo per ristadiare i pazienti con recidiva biochimica di tumore prostatico mediante imaging ibrido PET/RM con radiofarmaci innovativi (68Ga-PSMA e 68Ga-Bombesina).

E.2.2

Secondary objectives of the trial

- Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of recurrence sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR.
- Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics.
- Evaluate the impact of targeted therapy on lesions in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival.
In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.

- Valutazione dell’accuratezza diagnostica della 68Ga-PSMA PET/MR nell’identificazione dei siti di recidiva nei pazienti con recidiva biochimica di tumore prostatico dopo trattamento primario e confronto con le performance della 68Ga-Bombesina PET/MR.
- Correlazione tra i reperti descritti all’imaging con 68Ga-PSMA e 68Ga-Bombesina PET/MR con le caratteristiche cliniche ed istopatologiche.
- Valutare l’impatto di una terapia mirata sulle lesioni in termini di sopravvivenza libera da recidiva biochimica e sopravvivenza libera da recidiva clinica di malattia.
In particolare, verranno identificati i pazienti che potranno trarre maggiormente beneficio da quest’approccio mirato, in termini di predizione di imaging positivo e risposta al trattamento locale delle sedi di recidiva con chirurgia o radioterapia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with histological diagnosis of prostate cancer.
- Patients treated with radical therapy (radical prostatectomy or external beam radiotherapy, with or without adjuvant therapy) showing a serum increase in PSA values = 0.2 ng / mL.
- Age = 18 years.
- Able to sign the informed consent for the execution of the examination.

- Pazienti con diagnosi istologica di tumore prostatico
- Pazienti trattati con terapia radicale (prostatectomia radicale o radioterapia a fasci esterni, con o senza terapia adiuvante) che presentano un incremento sierico dei valori di PSA = 0.2 ng/mL.
- Età = 18 anni.
- In grado di firmare il consenso informato per l’esecuzione dell’esame.

E.4

Principal exclusion criteria

- Patients <18 years.
- Medical conditions that may significantly interfere with study compliance.
- Prior or ongoing hormone therapy.
- Contraindications to the PET / MR study (eg pacemaker wearers, etc.)

- Pazienti < 18 anni.
- Condizioni mediche che possano interferire significativamente con la compliance dello studio.
- Terapia ormonale pregressa o in atto
- Controindicazioni allo studio PET/RM (es. portatori di pacemaker, ecc.)

E.5 End points

E.5.1

Primary end point(s)

Provide an innovative approach to restaging patients with biochemical recurrence of prostate cancer by hybrid PET/MR imaging with innovative radiopharmaceuticals
(68Ga-PSMA and 68Ga-Bombesina).

Fornire un approccio innovativo per ristadiare i pazienti con recidiva biochimica di tumore prostatico mediante imaging ibrido PET/RM con radiofarmaci innovativi (68Ga-PSMA e 68Ga-Bombesina).

E.5.1.1

Timepoint(s) of evaluation of this end point

36 months

36 mesi

E.5.2

Secondary end point(s)

Evaluation of the diagnostic accuracy of 68Ga-PSMA PET/MR in the identification of relapse sites in patients with biochemical recurrence of prostate cancer after primary treatment and comparison with the performance of 68Ga-Bombesina PET/MR.; Correlation between the findings described in the imaging with 68Ga-PSMA and 68Ga-Bombesina PET/MR with the clinical and histopathological characteristics.; Evaluate the impact of targeted wound therapy in terms of biochemical recurrence-free survival and clinical disease recurrence-free survival. In particular, patients will be identified who will be more able to benefit from this targeted approach, in terms of positive imaging prediction and response to local treatment of recurrence sites with surgery or radiotherapy.

Valutazione dell’accuratezza diagnostica della 68Ga-PSMA PET/MR nell’identificazione dei siti di recidiva nei pazienti con recidiva biochimica di tumore prostatico dopo trattamento primario e confronto con le performance della 68Ga-Bombesina PET/MR.; Correlazione tra i reperti descritti all’imaging con 68Ga-PSMA e 68Ga-Bombesina PET/MR con le caratteristiche cliniche ed istopatologiche.; Valutare l’impatto di una terapia mirata sulle lesioni in termini di sopravvivenza libera da recidiva biochimica e sopravvivenza libera da recidiva clinica di malattia. In particolare, verranno identificati i pazienti che potranno trarre maggiormente beneficio da quest’approccio mirato, in termini di predizione di imaging positivo e risposta al trattamento locale delle sedi di recidiva con chirurgia o radioterapia.

E.5.2.1

Timepoint(s) of evaluation of this end point

36 months; 36 months; 36 months

36 mesi; 36 mesi; 36 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 (PET/MR study with 68Ga-PSMA and PET/MR with 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 PET/RM con 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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