Clinical Trials Register

Summary
EudraCT Number:	2021-005993-24
Sponsor's Protocol Code Number:	MIP7
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:	2022-09-13
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

2021-005993-24

A.3

Full title of the trial

Phase III Multicentre Prospective Comparative Study of Detection Rate of 18F-JK-PSMA-7 and of 18F-fluorocholine in Patients with Biochemical Recurrence of Prostate Cancer after Previous Treatment with Curative Intent.

Studio MIP7, comparativo, prospettico, multicentrico, di fase III del tasso di rilevamento di ripresa di malattia con 18F-JK-PSMA-7 e di 18F-fluorocolina in pazienti con recidiva biochimica di tumore prostatico dopo un precedente trattamento con intento curativo.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

MIP7

A.4.1

Sponsor's protocol code number

MIP7

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	ITEL TELECOMUNICAZIONI S.R.L.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ANNA TOLOMEO
B.5.2	Functional name of contact point	Qualified Person
B.5.3	Address:
B.5.3.1	Street Address	VIA LABRIOLA Z.I. snc
B.5.3.2	Town/ city	Ruvo di Puglia
B.5.3.3	Post code	70037
B.5.3.4	Country	Italy
B.5.4	Telephone number	0803611033
B.5.5	Fax number	0803611114
B.5.6	E-mail	a.tolomeo@itelte.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.2.1.2	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	Fluorocolina (18F)
D.3.2	Product code	[Fluorocolina (18F)]
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	fluorocolina (18F)
D.3.9.2	Current sponsor code	fluorocolina (18F)
D.3.9.3	Other descriptive name	18F-Fluorocholine
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/kg megabecquerel(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3 to 5
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	[18F]JK-PSMA-7
D.3.2	Product code	[18FJK-PSMA-7]
D.3.4	Pharmaceutical form	Radiopharmaceutical precursor, solution
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	[18F] JK-PSMA-7
D.3.9.2	Current sponsor code	9032
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/kg megabecquerel(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2 to 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	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

Patients with confirmed biochemical recurrence of Prostatic Cancer (PCa) after treatment with curative intention.

Pazienti con recidiva biochimica del cancro alla prostata dopo trattamento con intento curativo.

E.1.1.1

Medical condition in easily understood language

Patients with confirmed biochemical recurrence of Prostatic Cancer (PCa) after treatment with curative intention.

Pazienti con recidiva biochimica del cancro alla prostata dopo trattamento con intento curativo.

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	LLT
E.1.2	Classification code	10036921
E.1.2	Term	Prostate carcinoma
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

To show in an independent assessment by two readers blinded to clinical data
the superiority of 18F-JK-PSMA-7 over 18F-Fluorocholine in patient-based detection
rate of recurrent PCa in patients with confirmed biochemical recurrence after treatment
with curative intention.
Based on available bibliographic data we hypothesize that the detection rate of 18FJKPSMA-7 is at least 20% higher than that of 18F-Fluorocholine

Dimostrare, in una valutazione indipendente, effettuata in cieco da parte di due lettori dei dati clinici del paziente (i due lettori saranno esterni al sito in cui sono state effettuate le indagini PET)
la superiorità di 18F-JK-PSMA-7 su 18F-Fluorocolina nel tasso di rilevamento della ripresa di malattia in pazienti con recidiva biochimica del tumore alla prostata (PCa) dopo un precedente trattamento con intento curativo. Ipotizziamo che le prestazioni diagnostiche del 18F-JK-PSMA-7 siano almeno del 20% superiori rispetto a quelle del tracciante 18F-Colina.

E.2.2

Secondary objectives of the trial

• To evaluate the site-based sensitivity and specificity of 18F-JK-PSMA-7 and of 18FFluorocholine PET/CT for recurrent Pca;
• To evaluate the frequency of change of actual therapeutic management motivated by result of 18F-JK-PSMA-7 and by 18F-Fluorocholine PET/CT in comparison with
initially scheduled therapeutic management;
• To evaluate the discordance rate in 18F-JK-PSMA-7 and in 18F-Fluorocholine PET/CT reading among two blinded readers;
• To evaluate the safety profile of 18F-JK-PSMA-7 and of 18F-Fluorocholine.

- Valutare la sensibilità e la specificità della PET/TC con 18F-JK-PSMA-7 e con 18FFluorocolina nelle recidive biochimiche di PCa;
- Valutare la frequenza di cambiamento della gestione terapeutica, motivata dai risultati
delle indagini PET/TC con 18F-JK-PSMA e 18F-Fluorocolina rispetto alla gestione
terapeutica inizialmente programmata;
- Valutare il tasso di discordanza delle letture delle PET/TC con 18F-JK-PSMA e 18FFluorocolina tra i due lettori in cieco;
- Valutare il profilo di sicurezza del 18F-JK-PSMA-7 e 18F-Fluorocolina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Prescription of a PET examination (18F-Fluorocoline or 18F-PSMA) by the oncologist
or the urologist, based on the clinical evaluation of the individual patient
2. Histological confirmation of prostate malignancy
3. Patient must have had their primary PCa treated with surgery and/or radiation therapy;
salvage radiation to the prostate bed or pelvis is allowed
4. Patient must be = 18 years of age
5. Patient must have an Eastern Cooperative Oncology Group performance status = 2
6. For patients treated with radical prostatectomy: arise of PSA = 0.2 ng/mL (performed
in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive
radiation therapy defined by two subsequent PSA assessments performed over a 3-
month period in the same laboratory
7. Absence of any of the exclusion criteria
8. Signed informed consent.

1. Prescrizione di un’indagine PET (con 18F-PSMA o 18F-Fluorocolina) da parte di un oncologo
o urologo, sulla base della valutazione clinica individuale del paziente
2. Conferma istologica della neoplasia prostatica
3. Precedente trattamento per PCa mediante chirurgia e/o radioterapia; è consentita la
radiazione di salvataggio del letto prostatico o delle pelvi
4. Età = 18 anni
5. ECOG performance status = 2
6. Per ipazienti trattati con prostectomia radicale: insorgenza del PSA = 0.2 ng/mL (eseguito
nell’ultimo mese) o un aumento a 2 ng/mL o maggiore del PSA nadir dopo radioterapia,
definita da due successive valutazioni del PSA eseguite in un periodo di 3 mesi nello stesso
laboratorio.
7. Assenza di uno qualsiasi dei criteri di esclusione
8. Firma consenso informato.

E.4

Principal exclusion criteria

1. Absence of any of the inclusion criteria;
2. More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from
the last treatment
3. Spinal cord compression or impending spinal cord compression
4. Receipt of any other investigational agents in the previous 3 months
5. Inability to lie flat during or tolerate PET/CT
6. Hypersensitivity to active substance or any of excipients of Investigational Medicinal
Product or Comparator
7. Life expectancy <6 months
8. ECOG performance status >2
9. Refusal to sign informed consent
10. Participation in a concurrent clinical trial
11. Concomitant active malignancy
12. Subject deprived of its freedom by administrative or legal decision or who is under
guardianship.

1. Assenza di uno qualsiasi dei criteri di inclusione
2. Terapia di blocco androgenico (ADT) per più di 3 anni, terminata prima di 3 mesi dall’avvio
dello studio
3. Compressione o imminente compressione del midollo spinale
4. Utilizzo di qualsiasi altro agente sperimentale nei precedenti 3 mesi
5. Impossibilità a restare distesi durante l’esame PET/TC o intolleranza alla PET/TC
6. Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti del medicinale sperimentale
o del comparatore
7. Aspettativa di vita <6 mesi
8. ECOG performance status >2
9. Rifiuto alla firma del consenso informato
10. Partecipazione a studi clinici concomitanti
11. Malignità attiva concomitante
12. Soggetti incapaci di intendere e di volere.

E.5 End points

E.5.1

Primary end point(s)

The patient-based detection rate of 18F-JK-PSMA-7 and of 18F-Fluorocholine
PET/CT as a result of consensus of blind reading using an expert panel as a SOT. The
eventual major discordance of results of blind readings will be solved by third reader
blinded to results of previous blind readings.

Il tasso di rilevamento basato sul paziente di 18F-JK-PSMA-7 e di 18F-fluorocolina
PET / CT come risultato del consenso della lettura in cieco utilizzando un gruppo di esperti come SOT.
L'eventuale maggiore discordanza dei risultati delle letture in cieco sarà risolta dal terzo lettore
cieco ai risultati di precedenti letture in cieco.

E.5.1.1

Timepoint(s) of evaluation of this end point

After performing the second PET within 1 month of the first.

Dopo l'effettuazione della seconda PET entro 1 mese dalla prima.

E.5.2

Secondary end point(s)

The site-based sensitivity and specificity of 18F-JK-PSMA-7 and of 18FFluorocholine PET/CT of foci of recurrent Pca;
• The change of actual therapeutic management motivated by result of 18F-JK-PSMA-
7 and of 18F-Fluorocholine PET/CT in comparison with initially scheduled therapeutic
management;
• The discordance rate in 18F-JK-PSMA-7 and in 18F-Fluorocholine PET/CT reading
among two blinded readers;
• The adverse events or reactions related with use of 18F-JK-PSMA-7 and with use of
18F-fluorocholine.

La sensibilità e la specificità site-based di 18F-JK-PSMA-7 e di 18F Fluorocolina PET/CT di focolai di Pca ricorrente;
• Il cambiamento dell'attuale gestione terapeutica motivato dal risultato di 18F-JK-PSMA-
7 e della PET/TC con 18F-Fluorocolina rispetto alla terapia inizialmente programmata
gestione;
• Il tasso di discordanza nella lettura PET/CT di 18F-JK-PSMA-7 e 18F-fluorocolina
tra due lettori ciechi;
• Gli eventi avversi o le reazioni correlate all'uso di 18F-JK-PSMA-7 e all'uso di
18F-fluorocolina.

E.5.2.1

Timepoint(s) of evaluation of this end point

After performing the second PET within 1 month of the first.

Dopo l'effettuazione della seconda PET entro 1 mese dalla prima.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.1.7.1

Other trial design description

Due esami PET consecutivi, distanziati tra loro non più di un mese

Two consecutive PET exams, spaced no more than a month apart, with the IMP and the comparator.

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

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)

It is not intended as it is a diagnostic procedure.

Non è previsto in quanto procedura diagnostica

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

2022-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-07-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-08-22

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