Clinical Trials Register

Summary
EudraCT Number:	2019-003381-40
Sponsor's Protocol Code Number:	BED-PSMA-301
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-11-28
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

Germany - BfArM

A.2

EudraCT number

2019-003381-40

A.3

Full title of the trial

A prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) PET ligand in men with newly diagnosed prostate cancer

A.3.1

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

Study of diagnostic PET scan using rhPSMA-7.3 (18F) injection in men with newly diagnosed prostate cancer.

A.4.1

Sponsor's protocol code number

BED-PSMA-301

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	Blue Earth Diagnostics Ireland Ltd.
B.1.3.4	Country	Ireland
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	Blue Earth Diagnostics Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Blue Earth Diagnostics, Inc
B.5.2	Functional name of contact point	James O'Neill
B.5.3	Address:
B.5.3.1	Street Address	25 Mall Road, Suite 206
B.5.3.2	Town/ city	Burlington
B.5.3.3	Post code	MA 01803
B.5.3.4	Country	United States
B.5.4	Telephone number	+19199998670
B.5.6	E-mail	contact@blueearthdx.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	rhPSMA-7.3 (18F)
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	Not available
D.3.9.1	CAS number	2305081-64-3
D.3.9.2	Current sponsor code	rhPSMA-7.3 (18F)
D.3.9.3	Other descriptive name	Gallium 2,2',2''-(10-((3S,7S,12R,26R,34)-1,3,7,12,26,34-hexacarboxy-29-((4-(di-tert-butyl-[18F]fluorosilyl)benzamido)methyl)-5,10,17,20,28,31-hexaoxo-4,6,11,16,21,27,30-heptaazatetratriacontan-34-yl)-1,4,6,10-tetraazacyclododecane-1,4,7-triyl)triacetate
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	49
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

E.1.1.1

Medical condition in easily understood language

Prostate cancer

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	20.0
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 assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. At least one positive pelvic LN on PET (N1) and one positive LN as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.

E.2.2

Secondary objectives of the trial

To assess:
Verified Detection Rate(VDR) for M1 disease of IMP PET on patient(pt) level in pts with 1)newly diagnosed unfavorable intermediate-, high-, or very high-risk PCa using histopathology(HP) or confirmatory imaging(CI) or 2)negative CI.
Positive predictive value(PPV) of IMP PET for N1 and M1 lesions compared(cf) to HP or CI
PPV of IMP PET to detect pelvic LN mets cf to surgical pathology on a pt level in which a False Positive(FP) pt is defined as ≥1 FP region (R or L pelvis), regardless of coexisting TP findings.
Negative predictive value(NPV) of IMP PET to detect pelvic LN mets cf to surgical pathology on a pt level in which a False Negative(FN) pt is defined as having ≥1 FN region(R or L pelvis), regardless of any coexisting True Negative(TN) findings.
Impact of IMP on a)upstaging pts planned for RP or b)converting planned RP to external beam radiation therapy(EBRT).
Inter- and intra-reader agreement of IMP scan interpretation by blinded independent readers.
Safety of IMP.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
2. Patient is male and aged >18 years old.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Candidate for RP with PLND and scheduled to undergo the surgical procedure.
5. Patient with either:
a) Unfavorable intermediate risk (disease, defined as:
- Any Gleason Grade Grouping [GGG] 3, or
- GGG 2 with ≥50% of biopsy cores positive for PCa and/or >1
Intermediate Risk Factor [T2b; T2c; PSA 10-20] or
b) High risk or very high risk disease (per NCCN Guidelines Version
1.2020; PROS 2).

E.4

Principal exclusion criteria

1. Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
2. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
3. Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
4. Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3 (18F).
5. Patients with known hypersensitivity to the active substance or to any of the excipients of the IP.

E.5 End points

E.5.1

Primary end point(s)

• Sensitivity of rhPSMA-7.3 (18F) PET (as determined by central BIE) for detecting pelvic LN metastases compared to surgical pathology on a patient level.
• Specificity of rhPSMA-7.3 (18F) PET (as determined by central BIE) for detecting pelvic LN metastases compared to surgical pathology on a patient level.

E.5.1.1

Timepoint(s) of evaluation of this end point

After a single dose.

E.5.2

Secondary end point(s)

1. Percentage of patients in whom rhPSMA-7.3 (18F) imaging detects at least one verified M1 metastasis, as determined by central BIE.
2. Percentage of patients with negative conventional imaging for M1 disease in whom rhPSMA-7.3 (18F) PET detects at least one verified M1 metastasis, as determined by central BIE.
3. PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 lesions compared to histopathology or confirmatory imaging (M1 lesions only).
4. PPV of rhPSMA-7.3 (18F) PET for detecting pelvic LN metastases compared to surgical pathology on a patient level in which a FP patient is defined as having at least one FP region (right or left pelvis), regardless of any coexisting TP findings.
5. NPV of rhPSMA-7.3 (18F) PET for detecting pelvic LN metastases compared to surgical pathology on a patient level in which a FN patient is defined as having at least one FN region (right or left pelvis), regardless of any coexisting TN findings.
6. a) The percentage of patients being upstaged to N1 or M1 disease;
b) The percentage of patients in whom planned RP is converted to EBRT.
7. Kappa statistic for the agreement between and within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
8. Safety (AEs, vital signs clinical laboratory evaluations, 12-lead ECG and focused physical examinations) of rhPSMA-7.3 (18F) injection in patients.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of study

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

Yes

E.6.13.1

Other scope of the trial description

Evaluation of the sensitivity and specificity of rhPSMA-7.3 (18F) imaging.

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

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

Finland

Germany

Netherlands

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 end of patient participation is defined as when the last patient has completed all the study procedures and the results of the histology or confirmatory imaging are available in order to satisfy the SoT.

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:

225

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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.4.2

For a multinational trial

F.4.2.1

In the EEA

160

F.4.2.2

In the whole clinical trial

375

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)

rhPSMA-7.3 (18F) is a single-use diagnostic agent. No additional care for trial participants is planned once their participation in the study has ended. All patients will receive standard of care treatment in line with their medical condition as determined by their physician.

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

2020-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-02-18

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