Clinical Trials Register

Summary
EudraCT Number:	2014-003165-15
Sponsor's Protocol Code Number:	FACBC-STAGING-2014
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:	2014-08-27
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

2014-003165-15

A.3

Full title of the trial

18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER

A.3.1

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

18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER

A.3.2

Name or abbreviated title of the trial where available

FACBC-STAGING-2014

A.4.1

Sponsor's protocol code number

FACBC-STAGING-2014

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	AOU di Bologna Policlinico S.Orsola-Malpighi
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	Pubblic Research found (PRUa1GR-2013-00000171)
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	AOU di Bologna Policlinico S.Orsola-Malpighi
B.5.2	Functional name of contact point	U.O. Medicina Nucleare P.I. Dr.ssa
B.5.3	Address:
B.5.3.1	Street Address	Via Albertoni 15
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390516363185
B.5.6	E-mail	luciaronic@otmail.com

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	fluciclovine
D.3.2	Product code	18F-FACBC
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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 affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection

Pazienti affetti da carcinoma prostatico a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica

E.1.1.1

Medical condition in easily understood language

Patients affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection

Pazienti affetti da carcinoma prostatico a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10036946
E.1.2	Term	Prostatic cancer
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 evaluate the accuracy of 18F-FACBC PET/CT for preoperative lymph node staging in moderate to high risk prostate cancer patients who are already scheduled for prostatectomy and pelvic lymph node dissection

• Valutare l’accuratezza diagnostica della PET/TC con 18F-FACBC nella stadiazione linfonodale preoperatoria di pazienti affetti da carcinoma della prostata a rischio moderato-alto, già in nota operatoria per prostatectomia radicale e linfoadenectomia pelvica

E.2.2

Secondary objectives of the trial

• To evaluate 18F-FACBC performance respect to standard clinical predictive factors of disease (e.g. age, psa, gleason score,tumor stage, choline PET/CT results).
• To calculate 18F-FACBC sensitivity and specificity

• Valutare la performance della PET/TC con 18F-FACBC rispetto ai fattori prognostici clinici di malattia (ad esempio valore del PSA, Gleason Score, stadio del tumore, risultati della PET/TC con Colina).
• Calcolare sensibilità e specificità della 18F-FACBC PET/TC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects with biopsy-proven adenocarcinoma of the prostate
2. Moderate- to high risk prostate cancer as defined by:
-Moderate risk: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL;
-High risk: T3a or Gleason score 8-10 or PSA > 20 ng/mL.
3. Staging according to conventional preoperative workup tests (digital rectal examination, transrectal ultrasound, biopsy, likelihood of lymph node metastasis with clinical nomograms, Choline PET/CT)
4. Choline PET/CT negative for bone metastases
5. Surgical plan: prostatectomy with limited or extended lymph node dissection within 40 days from the imaging
6. Age≥18

1. Maschio maggiorenne affetto da cancro della prostata istologicamente confermato.
2. Cancro della prostata a classe di rischio da moderato ad alto così definito:
• Rischio moderato: T2b-T2c o GS 7 o PSA 10-20ng/ml;
• Rischio alto: T3a o GS 8-10 o PSA>20 ng/ml
3. Esami di stadiazione preoperatoria eseguiti come previsto nell’ambito del normale percorso assistenziale (ad esempio: esplorazione rettale, ecografia trans rettale, biopsia, calcolo di probabilità di metastasi linfonodali attraverso i nomogrammi clinici, PET/TC con Colina)
4. PET/TC con Colina negativa per metastasi ossee
5. Strategia chirurgica di prostatectomia radicale con dissezione linfonodale programmata entro 40 giorni dall’esecuzione dell’imaging
6. Ottenimento del consenso informato

E.4

Principal exclusion criteria

1. Inability to undergo 18F-FACBC PET/CT scanning for any reason.
2. Prior invasive malignancy (except basal cell carcinoma) unless disease-free for a minimum of 3 years
3. Severe acute co-morbidity
4. Specific preoperative therapy (hormonal treatment, chemotherapy, radiotherapy

1. Impossibilità di sottoporsi all’esame PET/TC con 18F-FACBC per qualsiasi ragione.
2. Pregressa storia di altri tumori (ad eccezione del carcinoma a cellule basali), a meno che non sia dimostrato periodo libero da malattia per un minimo di 3 anni.
3. Severa co-morbidità acuta.
4. Terapia specifica pre-operatoria (terapia ormonale, chemioterapia, radioterapia)

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

2 months

2 mesi

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

2 months

2 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

Yes

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

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.8.3

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.8.5

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

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

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

110

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)

Normal clinical practice

Normale percorso assistenziale

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

2014-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-02

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

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