Clinical Trials Register

Summary
EudraCT Number:	2020-000121-37
Sponsor's Protocol Code Number:	2020-PSMA
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-03-16
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2020-000121-37

A.3

Full title of the trial

A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

A.3.1

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

A Study on PET/CT Imaging (scan) with 18F-DCFPyL (radioactive substance) of Prostate Cancer having recurred shown by increase in PSA blood level

A.3.2

Name or abbreviated title of the trial where available

PYTHON

A.4.1

Sponsor's protocol code number

2020-PSMA

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	Curium PET France
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Curium PET France
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ICTA PM
B.5.2	Functional name of contact point	Marion DAVID
B.5.3	Address:
B.5.3.1	Street Address	11 Rue du Bocage
B.5.3.2	Town/ city	FONTAINE LES DIJON
B.5.3.3	Post code	21121
B.5.3.4	Country	France
B.5.4	Telephone number	33380534047
B.5.5	Fax number	33380571022
B.5.6	E-mail	marion.david@icta.fr

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	Radiolabeled molecule binding to the extracellular domain of prostate-specific membrane antigen
D.3.2	Product code	18F-DCFPyL
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-DCFPyL, 330MBq/mL, solution for injection
D.3.9.3	Other descriptive name	PSMA
D.3.9.4	EV Substance Code	SUB189818
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	330 to 3300
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.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.2.1.1.1	Trade name	Fluorocholine (18F) CIS bio international 225MBq/mL, solution injectable
D.2.1.1.2	Name of the Marketing Authorisation holder	CIS BIO INTERNATIONAL
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	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	FLUOROCHOLINE (18F) CHLORIDE
D.3.9.3	Other descriptive name	FLUOROCHOLINE (18F) CHLORIDE
D.3.9.4	EV Substance Code	SUB184899
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	112 to 3375
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.IMP: 3
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.2.1.1.1	Trade name	PROSTATEP 500 MBq/mL, solution injectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires Curium PET France
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	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	FLUOROCHOLINE (18F) CHLORIDE
D.3.9.3	Other descriptive name	FLUOROCHOLINE (18F) CHLORIDE
D.3.9.4	EV Substance Code	SUB184899
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 5000
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 with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrence

E.1.1.1

Medical condition in easily understood language

Patients with confirmed prostate cancer treated with radiotherapy or surgery with first recurrence (increase in PSA level)

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	21.0
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

Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT

E.2.2

Secondary objectives of the trial

Impact on patient treatment/management.
Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-lesion basis, using a composite SOR.
Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions using a composite SOR.
Safety of 18F-DCFPyL versus that of 18F-FCH

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male.
2. Age superior or equal to 18 years.
3. Histopathological proven prostate adenocarcinoma per original diagnosis.
4. First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.
5. Able and willing to provide informed consent and comply with protocol requirements
6. Patient who can undergo all study procedures per Investigator’s point of view
7. Patient with social insurance cover.

E.4

Principal exclusion criteria

1. ECOG > 2
2. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
3. History of adjuvant radiotherapy
4. History of cryotherapy, high-intensity focused ultrasound (HIFU)
5. Other active malignant tumour
6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
7. Unable to lie supine for imaging
8. Known allergy to investigational or reference products or to any excipients
9. Unable to provide written consent (linguistic or psychological inability)
10. Participation in another clinical study within one month prior to inclusion
11. Uncooperative, in the Investigator's opinion.
12. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship

E.5 End points

E.5.1

Primary end point(s)

Per-patient detection rate of 18F-DCFPyL PET/CT and 18F-FCH PET/CT for recurrence (either local, regional or distant), based on a surrogate SOR. The SOR will be made of an appropriate combination of tests performed in clinical routine practice during the following 10 months after the last 18F-tracer injection including: clinical data, PSA, histopathology and follow-up imaging exams.

E.5.1.1

Timepoint(s) of evaluation of this end point

10 months of follow-up after the last tracer administration

E.5.2

Secondary end point(s)

• Impact on patient treatment/management.
• Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.
• Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-lesion basis, using composite SOR.
• Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions using composite SOR.
• Safety of 18F-DCFPyL versus that of 18F-FCH

E.5.2.1

Timepoint(s) of evaluation of this end point

10 months of follow-up after the last tracer administration

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)

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

E.8.1.6

Cross over

Yes

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

The patient participation will end with the recording of adverse events occuring within 24 hours after the last tracer injection.Study will end 10 months after last patient completing the study.This period allows to collect sufficient data regarding clinical care of patients to assess the clinical value of performing PET scan with 18F-DCFPyl. Those data will be submitted to the truth panel experts in order to assess the impact/clinical meaning of the 18F-DCFPyl on patient treatment/management.

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

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:

174

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

217

F.4.2.2

In the whole clinical trial

217

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)

Treatment option after BCR is:
o Surveillance or
o In curative intent (no metastasis):
• Salvage radiotherapy (after radical prostatectomy)
• Salvage prostatectomy (after radiotherapy)
o In case of metastasis: Systemic treatment with Androgen Deprivation Therapy +/- abiraterone acetate + prednisone Or +/- Chemotherapy

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

2020-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-10-12

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