Clinical Trials Register

Summary
EudraCT Number:	2018-003652-21
Sponsor's Protocol Code Number:	2019-23
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
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

2018-003652-21

A.3

Full title of the trial

Interventional two arms open-label study for evaluating the diagnostic performance of PET PSMA in patients affected by biochemical recurrent prostate cancer.

Studio interventistico a due braccia, in aperto, per valutare le prestazioni diagnostiche di PET PSMA in pazienti affetti da carcinoma prostatico in ricaduta biochimica.

A.3.1

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

Interventional two arms open-label study for evaluating the diagnostic performance of PET PSMA in patients affected by biochemical recurrent prostate cancer.

Studio interventistico a due braccia, in aperto, per valutare le prestazioni diagnostiche di PET PSMA in pazienti affetti da carcinoma prostatico in ricaduta biochimica.

A.3.2

Name or abbreviated title of the trial where available

PSMA-2018

A.4.1

Sponsor's protocol code number

2019-23

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 CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS Sacro Cuore Don Calabria
B.5.2	Functional name of contact point	Unità per la Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Don A. Sempreboni, 5
B.5.3.2	Town/ city	Negrar (VR)
B.5.3.3	Post code	37024
B.5.3.4	Country	Italy
B.5.4	Telephone number	0456014854
B.5.6	E-mail	ricerca.clinica@sacrocuore.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	18F-PSMA
D.3.2	Product code	[18F-PSMA]
D.3.4	Pharmaceutical form	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	18F-PSMA
D.3.9.2	Current sponsor code	18F-PSMA
D.3.9.3	Other descriptive name	18F-PSMA
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	900 to 3100
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	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.2.5	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-CHOLINE
D.3.2	Product code	[18F-CHOLINE]
D.3.4	Pharmaceutical form	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	18F-fluoromethylcholine
D.3.9.2	Current sponsor code	18F-fluoromethylcholine
D.3.9.3	Other descriptive name	18F-CHOLINE
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	900 to 3100
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

Biochemical recurrent prostate cancer

Carcinoma della prostata in recidiva biochimica

E.1.1.1

Medical condition in easily understood language

Biochemical recurrent prostate cancer

Tumore della prostata in ricaduta biochimica

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10036911
E.1.2	Term	Prostate cancer recurrent
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 evaluate the diagnostic performance of 18F-PSMA versus 18F-Choline, in detecting relapses of prostate cancer. We hypothesize that the 18F-PSMA diagnostic performance is at least 20% higher respect to that of the 18F-Choline tracer.

Valutare le prestazioni diagnostiche di 18F-PSMA rispetto a 18F-colina, nel rilevare le ricadute del cancro alla prostata. Si ipotizza che le prestazioni diagnostiche di 18F-PSMA siano almeno il 20% più elevate rispetto a quelle del tracciante 18F-Colina.

E.2.2

Secondary objectives of the trial

To analyze if the use of 18F-PSMA, by an early detection of metastases, optimizes the overall management of the patient, allowing for example targeted radiotherapeutic interventions instead of systemic pharmacological treatments.

Analizzare se l'uso di 18F-PSMA, mediante una diagnosi precoce di metastasi, ottimizza la gestione complessiva del paziente, consentendo ad esempio interventi radioterapeutici mirati invece di trattamenti farmacologici sistemici.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histological confirmation of prostate malignancy.
2. Patient must have had their primary tumor treated with surgery and/or radiation and salvage radiation to the prostate bed or pelvis is allowed.
3. Patient must be = 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
4. Patient must have an Eastern Cooperative Oncology Group performance status = 2.
5. Diagnosis of biochemical failure:
For patients treated with surgery: arise of PSA = 0.2 ng/ml.
For patients treated with radical RT: PSA level +2 ng/ml from nadir.

1. conferma istologica di neoplasia della prostata
2. tumore primitivo trattato con chirurgia e/o radioterapia; la radioterapia di salvataggio sul letto prostatico o pelvico è consentita
3 età = 18 anni, capacità di comprendere e firma del consenso informato
4. ECOG Performance Status = 2
5. Diagnosi di fallimento biochimico:
Per i pazienti trattati con chirurgia: PSA = 0,2 ng/ml
Per i pazienti trattati con RT radicale: livello di PSA +2 ng/ml dal nadir

E.4

Principal exclusion criteria

1. More than 3 years of ADT, with the most recent ADT treatment having occurred < 6 months prior to enrollment.
2. Spinal cord compression or impending spinal cord compression.
3. Receipt of any other investigational agents in the previous 3 months
4. Inability to lie flat during or tolerate PET/CT.
5. Refusal to sign informed consent
6. Participation in a concurrent clinical trial.

1. Oltre 3 anni di ADT, con il trattamento ADT più recente avvenuto <6 mesi prima dell'arruolamento
2. Compressione del midollo spinale o compressione imminente del midollo spinale
3. Assunzione di altri farmaci sperimentali nei 3 mesi precedenti
4. Impossibilità di sdraiarsi o tollerare la PET/CT.
5. Rifiuto di firmare il consenso informato
6. Partecipazione a una sperimentazione clinica concomitante

E.5 End points

E.5.1

Primary end point(s)

18F-PSMA or choline tests results at Visit 2 by all experts; the test will be considered positive when two expert examiners (+ 5000 examinations performed) will agree on the lesion(s), or negative when both experts will judge the injury as negative. Results from patients with diagnostic uncertainty will be reassessed by a third expert to decrease uncertainty and to offer the best diagnosis procedure to the patient.

Risultati dell’esame con 18F-PSMA o 18F-colina alla visita 2, da parte di tutti gli esperti: il test sarà considerato positivo quando due esaminatori esperti (+ 5000 esami eseguiti) concorderanno sulla/e lesione/i, o negativo quando entrambi gli esperti giudicheranno come negativo la lesione. I pazienti con incertezza diagnostica saranno rivalutati da un terzo esperto per diminuire l'incertezza e offrire la migliore procedura di diagnosi al paziente.

E.5.1.1

Timepoint(s) of evaluation of this end point

At visit 2, after TC-PET execution.

Al momento dell'esecuzione dell'esame TC-PET (visita 2).

E.5.2

Secondary end point(s)

Disease-free time after:
• Hormonal therapy,
• Radiotherapy,
• Watchful observation,
• Surgical treatment
as per normal clinical practice.

Tempo libero dalla malattia dopo:
• Terapia ormonale,
• Radioterapia,
• Osservazione vigile,
• trattamento chirurgico
come da normale pratica clinica

E.5.2.1

Timepoint(s) of evaluation of this end point

At usual follow.up visit, as per normal clinical practice, every three months for the first year and every 6 months for the following two years.

Alle visite di controllo previste, come da normale pratica clinica, ogni 3 mesi per il primo anno e ogni 6 mesi per i due anni successivi.

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

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

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

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:

358

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

536

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

894

F.4.2

For a multinational trial

F.4.2.1

In the EEA

894

F.4.2.2

In the whole clinical trial

894

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)

As per normal clinical practice.

Come da normale pratica clinica.

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

2020-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-11-09

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