Clinical Trials Register

Summary
EudraCT Number:	2016-005284-13
Sponsor's Protocol Code Number:	ARTO
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:	2021-02-09
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

2016-005284-13

A.3

Full title of the trial

A 2 arm, phase II controlled randomized trial comparing efficacy and safety of abiraterone and abiraterone associated with Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial)

Studio randomizzato controllato di fase II a due bracci finalizzato alla comparazione dell’efficacia e della sicurezza di abiraterone ed abiraterone associate a radioterapia ablative in pazienti con carcinoma prostatico oligometastatico resistente alla castrazione (ARTO trial)

A.3.1

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

Phase II trial testing Ablative radiotherapy in metastatic prostate
cancer, resistant to hormonal therapy and with number of metastatic lesions lower or equal to three.

Trial randomizzato di fase II sulla radioterapia ablativa in pazienti con carcinoma della
prostata oligometastatico resistente alla castrazione (ARTO)

A.3.2

Name or abbreviated title of the trial where available

ARTO

A.4.1

Sponsor's protocol code number

ARTO

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	DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE
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	Dipartimento "Mario Serio" Univ. studi Firenze
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	Dipartimento "Mario Serio" Univ. studi Firenze
B.5.2	Functional name of contact point	Data Manager
B.5.3	Address:
B.5.3.1	Street Address	Viale Morgagni, 50
B.5.3.2	Town/ city	Firenze
B.5.3.3	Post code	50134
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390557947192
B.5.5	Fax number	+390552751835
B.5.6	E-mail	datamanager.ng.rt@sbsc.unifi.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	Yes
D.2.1.1.1	Trade name	ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V.
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	Zytiga
D.3.2	Product code	[41427016]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	abiraterone acetato
D.3.9.1	CAS number	154229-18-2
D.3.9.2	Current sponsor code	41427016
D.3.9.3	Other descriptive name	Abiraterone acetate
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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	No
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

Oligometastatic prostate cancer, castration resistant

Carcinoma prostatico oligometastatico resistente alla castrazione

E.1.1.1

Medical condition in easily understood language

Patient affected by castration resistant prostate cancer, metastatic, with a number of metastatic lesions lower or equal to three

Paziente con carcinoma prostatico non responsivo alla terapia ormonale, metastatico, con un numero di lesioni metastatiche inferiore o uguale a 3

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	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

Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).

L’obiettivo primario dello studio sarà la risposta biochimica, definita come la riduzione del PSA > 50% misurata entro 6 mesi, in pazienti oligometastatici con lesioni ossee o linfonodali sottoposti a SBRT in associazione ad abiraterone acetato (Braccio sperimentale) in confronto a pazienti trattati con solo abiratero-ne acetato (braccio di controllo)

E.2.2

Secondary objectives of the trial

- To assess, during the observation period, the radiographic progression free survival (rPFS) and/or biochemical PFS in nodal and/or bone oligometastatic (¿ 3 lesions) castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).

- To describe SBRT+AA safety.

- To compare PSA trend in the two treatment arms during the observation period.

- To compare the overall survival (OS) in the two treatment arms.
- To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period.
- To describe the use of analgesic drugs and pain experience by means presence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF)

-Valutare la sopravvivenza libera da progressione ra-diologica e biochimica in pazienti oligometastatici con lesioni ossee o linfonodali sottoposti a SBRT in associazione ad abiraterone acetato (Braccio speri-mentale) in confronto a pazienti trattati con solo abiraterone acetato (braccio di controllo)
- Descrivere la sicurezza dell’associazione tra abirate-rone acetato e SBRT
- Comparare il trend di PSA nei due bracci di tratta-mento durante il periodo di osservazione
- Comparare la sopravvivenza assoluta nei due bracci di trattamento
- Descrivere i dati di qualità della vita, misurati tramite EORTC QLC-C30 durante il periodo di osservazione
- Descrivere l’utilizzo di farmaci analgesici e la sinto-matologia dolorosa tramite la presenza/assenza di sintomi misurata tramite Brief Pain Inventory Short Form (BPISF)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Metastatic disease and only minor or equal at 3 metastatic sites recorded (irrespective if nodal or bone).
2. Patients should have received abiraterone acetate for 30 days before start of radiotherapy (+ or – 3 days)
3. Asymptomatic or mildly symptomatic pa-tients according to clinical judgement.

4. Age more and equal 18 years.

5. Subject must have signed an informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study.

1. Malattia metastatica con un numero di siti metastatici inferiore o uguale a 3 (sia al livello osseo che linfonodale)
2. I pazienti devono aver ricevuto abiraterone acetato per 30 giorni prima dell’inizio della radioterapia nel braccio speri-mentale (+/- 3 giorni)
3.Pazienti asintomatici o lievemente sintomatici secondo giudizio clinico
4. Età maggiore ed uguale a 18 anni
5. I pazienti devono aver firmato un consenso informato che indichi la comprensione delle procedure richieste dallo studio e del loro obiettivo e che indichi la chiara volontà di partecipare allo studio.

E.4

Principal exclusion criteria

1. More than 3 metastatic lesions.

2. Visceral envolvement.

3. Known or suspected contraindications or hypersensitivity to Abiraterone, GnRH agonist/antagonist or Radiotherapy.
4. Comorbidities that contraindicate Abiraterone, GnRH agonist/antagonist or Radiotherapy.
5. Any condition for which, in the option of the investigator, participation would not be in the best interest of subject.
6. Patients who received previous therapies for mCRPC (excluded ormonal therapy)

Piu di 3 lesioni metastatiche
2. Interessamento viscerale
3. Controindicazione nota o sospetta o ipersensibilita' all'abiraterone, GnRH agonisti/antagonisti o radioterapia.
4. Comorbidita' che controindichino GnRH agonisti/antagonisti o radioterapia.
5. Qualsiasi condizione per la quale, a giudizio dell'investigatore, la partecipazione non sia nel maggiore interesse dell soggetto
6. Precedente somministrazione di terapie per mCRPC (escluso terapia ormonale)

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months

6 mesi

E.5.2

Secondary end point(s)

castration resistant prostate cancer patients undergoing SBRT in combination with AA; To compare PSA trend in the two treatment arms during the observation period.; To compare the overall survival (OS) in the two treatment arms.; To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period; To describe the use of analgesic drugs and pain experience by means pres-ence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF)

Descrivere la sicurezza dell’associazione tra abiraterone acetato e SBRT; Comparare il trend di PSA nei due bracci di trattamento durante il periodo di osservazione; Comparare la sopravvivenza assoluta nei due bracci di trattamento; Descrivere i dati di qualità della vita, misurati tramite EORTC QLC-C30 durante il periodo di osservazione; Descrivere l’utilizzo di farmaci analgesici e la sintomatologia dolorosa tramite la presenza/assenza di sintomi misurata tramite Brief Pain Inventory Short Form (BPISF)

E.5.2.1

Timepoint(s) of evaluation of this end point

40 months; 40 months; 40 months; 40 months; 40 months

40 mesi; 40 mesi; 40 mesi; 40 mesi; 40 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

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

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

Yes

E.8.2.3.1

Comparator description

AGGIUNTA TRATTAMENTO RADIOTERAPICO STEREOTASSICO SULLE LESIONI TARGET AL TRATTAMENTO SISTEMICO CON A

STEREOTACTIC RADIOTHERAPY ADDITION TO SYSTEMIC TREATMENT WITH ABIRATERONE

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

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:

114

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

174

F.4.2

For a multinational trial

F.4.2.1

In the EEA

174

F.4.2.2

In the whole clinical trial

174

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)

Patients will follow normal terapeutic and follow up procedures, according to local clinical practice

I pazienti proseguiranno le normali procedure terapeutiche e di follow up secondo la pratica clinica locale

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

2018-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-09

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

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