Clinical Trials Register

Summary
EudraCT Number:	2017-001395-38
Sponsor's Protocol Code Number:	CALIPSO-study
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:	2020-11-05
Trial results	View 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

2017-001395-38

A.3

Full title of the trial

Treatment of Metastatic prostate cancer castration resistant (mCRPC) with 223RaCl2: response evaluation with a novel tracer 68Ga-PSMA PET molecular imaging

Studio multicentrico di fase II di trattamento con Radio223 dicloruro in pazienti affetti da mCRPC, sottoposti a valutazione della risposta al trattamento con 68Ga-PSMA PET

A.3.1

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

Response evaluation with 68Ga-PSMA PET of metastatic prostate cancer castration resistant patients in treatment with 223RaCl2

Valutazione con 68Ga-PSMA PET della risposta al trattamento con Radio223 dicloruro in pazienti affetti carcinoma della prostata metastatico castrazione resistente

A.3.2

Name or abbreviated title of the trial where available

CALIPSO

A.4.1

Sponsor's protocol code number

CALIPSO-study

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 USL DELLA VALLE D'AOSTA
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	Bayer S.p.A.
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Azienda Ospedaliera della Valle d'Aosta
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	Azienda USL della Valle d'Aosta
B.5.2	Functional name of contact point	S.C. Medicina Nucleare
B.5.3	Address:
B.5.3.1	Street Address	Viale Ginevra 3
B.5.3.2	Town/ city	Aosta
B.5.3.3	Post code	11100
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390165543311
B.5.5	Fax number	00390165543655
B.5.6	E-mail	cpoti@ausl.vda.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	68-Ga-HBED-CC-PSMA
D.3.2	Product code	[68Ga-PSMA]
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-11
D.3.9.1	CAS number	1366302-52-4
D.3.9.2	Current sponsor code	PSMA-11
D.3.9.3	Other descriptive name	PSMA-HBED-CC
D.3.9.4	EV Substance Code	SUB171041
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/kg megabecquerel(s)/kilogram
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	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 mCRPC eligible to treatment with 223RaCl2

Pazienti con neoplasia prostatica metastatica castrazione resistente eleggibili per il trattamento con Radio223 dicloruro

E.1.1.1

Medical condition in easily understood language

Metastatic prostate cancer castration resistant patients eligible to radiometabolic treatment with 223RaCl2 for bone metastasis

Pazienti con neoplasia prostatica metastatica castrazione resistente eleggibili a trattamento radiometabolico con Radio223 dicloruro per le metastasi ossee

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	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10005993
E.1.2	Term	Bone metastases
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10036223
E.1.2	Term	Positron emission tomography
E.1.2	System Organ Class	100000004848

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10062904
E.1.2	Term	Hormone-refractory prostate cancer
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

-Response evaluation of patients treated with 223RaCl2 (Xofigo®, Bayer) using 68Ga-PSMA imaging PET;
- Evaluate if PSMA-PET response can be used as a biomarker to predict survival in patients treated with 223RaCl2 (Xofigo®, Bayer).

- Valutazione della risposta al trattamento con Radio223 dicloruro (Xofigo®, Bayer) utilizzando la metodica 68Ga-PSMA PET/CT;
- Valutare se la risposta alla PET può essere considerata un biomarker per predire la sopravvivenza in pazienti trattati con Radio223 dicloruro.

E.2.2

Secondary objectives of the trial

- Comparison of PSMA-PET results with a validated imaging (bone scintigraphy);
-Correlation of PSA and ALP changes with results of PSMA-PET;
-Correlation of PSMA-PET response with time to first symptomatic skeletal event (SSE).

- Confronto dei risultati PET con una metodica di imaging validata (scintigrafia ossea);
- Correlazione delle variazioni del PSA e fosfatasi alcalina con i risultati della PET;
- Correlazione della risposta PET con il tempo di comparsa del primo evento scheletrico sintomatico (SSE).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age>45
2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigational nature of study
3.Histologically or cytologically confirmed adenocarcinoma of the prostate
4.Known hormone refractory disease (castrate serum testosterone level: =50 ng/dL)
5.Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within 4 weeks
6.Bone pain (Brief Pain Inventory BPI-SF = 2 )
7.ECOG Performance status (PS): 0-2
8.Acceptable haematology and serum biochemistry screening values as follows: WBC= 3000/mm3 , ANC= 1500/mm3, PLT= 100000/mm3 , Hb= 10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine <1.5 x the upper limit of normal

1.Età>45
2.Sottoscrizione del consenso informato
3.Tumore della prostata confermato istologicamente
4.Malattia ormonorefrattaria (livelli di testosterone sierico: =50 ng/dL)
5.Plurime metastasi scheletriche (= 2 lesioni) alla scintigrafia ossea eseguita da meno di un mese
6.Dolore osseo (Brief Pain Inventory BPI-SF = 2 )
7.ECOG : 0-2
8.Recenti esami ematochimici come segue: WBC= 3000/mm3 , ANC= 1500/mm3, PLT= 100000/mm3 , Hb= 10 g/dl, bilirubina totale = 2.0 mg/dL, ALT and AST = 2.5 volte il limite superiore, creatinina<1.5 x il limite superiore di norma

E.4

Principal exclusion criteria

1.Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc) or to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)
2.Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI
3.Visceral metastases assessed by thorax and abdominal/pelvic CT within previous 8 weeks
4.Malignant lymphoadenopathy exceeding 3 cm in short axis diameter assessed by thorax and abdominal/pelvic CT within previous 8 weeks
5.Patients with known inflammatory bowel disease (IBD)
6.Patients with known osteonecrosis of the jaw (ONJ)
7.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug
8.Concomitant chemotherapy, abiraterone or enzalutamide therapy

1.Impossibilità a mantenere la posizione ottimale per tutta la durata dell'indagine (p.e. tosse, severa artrite..) e claustrofobia
2.Peso superiore al limite del tomografo
3.Metastasi viscerali diagnosticate alla TC torace-addome eseguita da meno di 8 settimane
4.Linfoadenopatie superiori a 3 cm in diametro assiale diagnosticate alla TC torace-addome eseguita da meno di 8 settimane
5.Pazienti con malattia infiammatoria intestinale
6.Pazienti con osteonecrosi della mandibola
7.Partecipazione ad altri trial clinici con farmaci sperimentali nelle 4 settimane precedenti lo screening o entro 5 emivite del farmaco
8. Concomitante chemioterapia o terapia con abiraterone o enzalutamide

E.5 End points

E.5.1

Primary end point(s)

Response evaluation of patients treated with 223RaCl2 (Xofigo®, Bayer) using 68Ga-PSMA imaging PET;

Valutazione della risposta al trattamento con Radio223 dicloruro (Xofigo®, Bayer) utilizzando la metodica 68Ga-PSMA PET/CT

E.5.1.1

Timepoint(s) of evaluation of this end point

20 months

20 mesi

E.5.2

Secondary end point(s)

Evaluate if PSMA-PET response can be used as a biomarker to predict survival in patients treated with 223RaCl2 (Xofigo®, Bayer)

Valutare se la risposta alla PET può essere considerata un biomarker per predire la sopravvivenza in pazienti trattati con Radio223 dicloruro.

E.5.2.1

Timepoint(s) of evaluation of this end point

30 months

30 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

Yes

E.6.4

Safety

Yes

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

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

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

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)

Follow-up clinico

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

2017-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
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