Clinical Trials Register

Summary
EudraCT Number:	2014-005345-50
Sponsor's Protocol Code Number:	RD-FCH-2014
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-03-03
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

Czechia - SUKL

A.2

EudraCT number

2014-005345-50

A.3

Full title of the trial

Diagnostic feasibility and morfological and functional correlation of PET examination in use of [18F]-Fluorocholin inj. in patients with prostate cancer

Diagnostická proveditelnost a morfologicko-funkční korelace vyšetření PET při použití [18F]-Fluorocholin inj. u pacientů s karcinomem prostaty

A.3.1

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

Diagnostic feasibility of PET examination with use of [18F]-Fluorocholin inj. in patients with prostate carncer

Diagnostická proveditelnost vyšetření PET při použití přípravku [18F]-Fluorocholin inj. u pacientů s rakovinou prostaty

A.3.2

Name or abbreviated title of the trial where available

Fluoromethylcholinium-(18F)-chlorid inj.

A.4.1

Sponsor's protocol code number

RD-FCH-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	Masarykův onkologický ústav
B.1.3.4	Country	Czech Republic
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	Masarykův onkologický ústav
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Masarykův onkologický ústav
B.5.2	Functional name of contact point	Oddělení klinických hodnocení
B.5.3	Address:
B.5.3.1	Street Address	Žlutý kopec 7
B.5.3.2	Town/ city	Brno
B.5.3.3	Post code	656 53
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	00420543136611
B.5.6	E-mail	demlova@mou.cz

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]-Fluorocholin inj.
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	[18F]- Fluorocholin
D.3.9.3	Other descriptive name	FLUOROMETHYL-(18F)-DIMETHYL-2-HYDROXYETHYL-AMMONIUM
D.3.9.4	EV Substance Code	SUB124446
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	100 to 1500
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

Prostate cancer

Rakovina prostaty

E.1.1.1

Medical condition in easily understood language

Prostate cancer

Rakovina prostaty

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	17.1
E.1.2	Level	PT
E.1.2	Classification code	10060862
E.1.2	Term	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

To prove accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj. administrated in the activity of 4 MBq / kg in the cancer tissue of prostate cancer and eventuual metastases.

Prokázat akumulaci radiofarmaka [18F]-Fluorocholin inj., podaného v aktivitě 4 MBq / kg tělesné hmotnosti v nádorové tkáni karcinomu prostaty a případných metastázách.

E.2.2

Secondary objectives of the trial

1. Assessment of safety of the investigational medicinal product

2. Comparison of accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj., image contrast (defined as relation of intensity of acumulation of the radiopharmaceutical medicinal product in the tumour to intensity of accumulation in body background) and diagnostic quality in early imaging (10 minutes after the application) and late imaging (60 minutes after the application).

1. Hodnocení bezpečnosti aplikovaného přípravku.

2. Srovnání akumulace radiofarmaka [18F]-Fluorocholin inj., obrazového kontrastu (vyjádřeného poměrem intenzity akumulace RF v tumoru vzhledem k intenzitě akumulace v tělním pozadí) a diagnostické kvality při zobrazení časném (10 minut po aplikaci) a pozdním (60 minut po aplikaci).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• age ≥ 18 years
• clinically localized/locally progressed prostate cancer- high risk group (clinical stage cT2c or higher or PSA higher than 20 ng/ml or Gleason score more than 8-10) before the planned curative therapy to exclude a metastatic impairment
• examination of the disseminated prostate cancer to assess the impaired area
• biochemical recidive after a radical treatment od prostate cancer to localise the recidive and eventually to plan a targeted local therapy
• signed informed consent
• ECOG PS 0-1
• Laboratory values:
• bilirubin < 1,5x maximum normal value
• creatinine < 1,5x maximum normal value
• urea < 1,5x maximum normal value
• trombocytes > 50 x 109 / l
• diagnostic CT examination of abdomen and pelvis performed max. 28 days prior to study PET examination
• assessment of PSA max. 14 days prior to study PET examination, in case of relaps of the disease - assessment of PSA doubling time
• Aa least 3 weeks from eventual last application of anticancer treatment and 6 weeks from
eventual last radiotherapy (first 4 subjects should not by premedicated neither by chemotherapy nor by radiotherapy in order to restrict the possible infuence of those treatmensts on the quality of examinations)
• ability to cooperate according to the requirements of protocol

• věk ≥ 18 let
• klinicky lokalizovaný / lokálně pokročilý karcinom prostaty zařazený do skupiny s vysokým rizikem (klinické stadium cT2c a vyšší NEBO PSA více než 20 ng/ml NEBO Gleason skóre 8-10) před zvažovanou kurativní léčbou k vyloučení metastatického postižení
• vyšetření u diseminovaného karcinomu prostaty k posouzení rozsahu postižení
• biochemická recidiva po radikální léčbě karcinomu prostaty za účelem lokalizace recidivy a případného plánování cílené lokální léčby
• podepsaný informovaný souhlas
• ECOG PS 0-1
• laboratorní hodnoty:
• bilirubin < 1,5x horní hranice normálu
• kreatinin < 1,5x horní hranice normálu
• urea < 1,5x horní hranice normálu
• trombocyty > 50 x 109 / l
• diagnostické CT vyšetření břicha a pánve provedené max. 28 dnů před studiovým PET vyšetřením
• odběr hodnoty PSA max. 14 dnů před studiovým PET vyšetřením, v případě relapsu onemocnění stanovení PSA doubling time
• minimálně 3 týdny od případné poslední aplikace protinádorové léčby a 6 týdnů od případné poslední radioterapie (první 4 subjekty hodnocení by optimálně neměly být předléčeny chemoterapií ani radioterapií, aby byl omezen možný vliv této léčby na kvalitu vyšetření)
• schopnost subjektu hodnocení spolupracovat dle požadavků protokolu

E.4

Principal exclusion criteria

• hypersensitivity to any compound of the investigational medicinal product
• renal impairment
• urea > 1,5x maximum normal value
• creatinine > 1,5x maximum normal value
• presence of any psychical, familial, social or geographic obstacles which could cause noncompliance with the protocol. These facts must be discussed with the subject prior to his/her inclusion
• weight more than 204 kg or deformity of thorax that could make the passage of the gantry of the device (diameter 70 cm) impossible
• claustrophobia or incapacity to lie 20 minutes without moving

• hypersenzitivita na jakoukoliv součást hodnoceného přípravku
• porucha funkce ledvin
• urea > 1,5x horní hranice normálu
• kreatinin > 1,5x horní hranice normálu
• přítomnost jakýchkoli duševních, rodinných, sociálních či geografických skutečností, které by mohly být překážkou postupu v souladu s protokolem. Tyto skutečnosti musí být se subjektem hodnocení před jeho zařazením do klinického hodnocení prodiskutovány
• hmotnost subjektu hodnocení nad 204 kg nebo deformita trupu bránící prostupu přes otvor gantry přístroje o průměru 70 cm
• klaustrofobie nebo neschopnost ležet 20 min bez pohnutí

E.5 End points

E.5.1

Primary end point(s)

Proven accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj. administrated in the activity of 4 MBq / kg in the cancer tissue of prostate cancer and eventuual metastases.

Prokázání akumulace radiofarmaka [18F]-Fluorocholin inj., podaného v aktivitě 4 MBq / kg tělesné hmotnosti v nádorové tkáni karcinomu prostaty a případných metastázách.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 hours

24 hodin

E.5.2

Secondary end point(s)

1. Assessment of safety of the investigational medicinal product

2. Comparison of accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj., image contrast (defined as relation of intensity of acumulation of the radiopharmaceutical medicinal product in the tumor to intensity of accumulation in body background) and diagnostic quality in early imaging (10 minutes after the application) and late (60 minutes after the application).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. During the whole clinical trial
2.10 minutes after the application and 60 minutes after the application

1. během celé doby trvání KH
2. 10 minut po aplikaci a 60 minut po aplikaci

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)

Yes

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

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

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

Poslední návštěva posledního subjektu hodnocení

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

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)

none

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

2015-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-11-04

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