Clinical Trials Register

Summary
EudraCT Number:	2016-004694-41
Sponsor's Protocol Code Number:	PRX302-2-08
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-12-01
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

UK - MHRA

A.2

EudraCT number

2016-004694-41

A.3

Full title of the trial

A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically Significant, Localised, Low- to Intermediate-Risk Prostate Cancer that is Associated with an MRI Lesion

A.3.2

Name or abbreviated title of the trial where available

Intraprostatic PRX302 injection to treat localised prostate cancer

A.4.1

Sponsor's protocol code number

PRX302-2-08

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	Sophiris Bio Corp. 1258 Prospect Street La Jolla, CA 92037 USA
B.1.3.4	Country	United States
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	Sophiris Bio Corp
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sophiris Bio Corp
B.5.2	Functional name of contact point	Allison Hulme
B.5.3	Address:
B.5.3.1	Street Address	1258 Prospect Street
B.5.3.2	Town/ city	La Jolla
B.5.3.3	Post code	CA 92037
B.5.3.4	Country	United States
B.5.4	Telephone number	+1650222-5679
B.5.5	Fax number	+1858412-5693

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.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	topsalysin
D.3.2	Product code	PRX302
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraprostatic use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Topsalysin
D.3.9.1	CAS number	RN917121256
D.3.9.2	Current sponsor code	PRX302
D.3.9.3	Other descriptive name	TOPSALYSIN
D.3.9.4	EV Substance Code	SUB184912
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Genetically modified, recombinant version of the pore-forming protein proaerolysin

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	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10036966
E.1.2	Term	Prostatic neoplasms and hypertrophy
E.1.2	System Organ Class	100000004872

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 safety and tolerability of a single, and if applicable a second, administration of PRX302 when used to selectively target and focally ablate histologically proven, clinically significant, localised, low- to intermediate-risk prostate cancer that is associated with an MRI lesion.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of a single, and if applicable a second, administration of PRX302 to selectively target and focally ablate histologically proven, clinically significant, localised, low- to intermediate-risk prostate cancer that is associated with an MRI lesion, as assessed by biopsy (histological), imaging (MRI) and PSA outcomes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men aged ≥40 years and life expectancy of ≥10 years.
2. Serum prostate-specific antigen (PSA) ≤15ng/mL.
3. In the planned treatment zone, histologically proven clinically significant prostate cancer of maximum Gleason Score 7 (3+4 or 4+3)
• In the presence of Gleason sum of 7, the MCCL must not exceed 10mm.
• In the presence of Gleason sum of 7, there is no minimum cancer core length requirement.
• In the presence of Gleason patterns 3+3, the MCCL must exceed 5mm.
• In the presence of Gleason sum of 6, the MCCL must not exceed 10mm.
4. Radiological stage T1-T2 N0 Mx/M0 disease.
5. A visible lesion on mpMRI, Prostate Imaging-Reporting and Data System (PI-RADS) (version 2) score 3, 4 or 5 and up to a maximum volume of 1mL that is accessible to administration of PRX302 via transperineal injection. mpMRI to be obtained at the screening visit or within 6 months prior to dosing (using the same MRI magnet strength that will be used for the patient’s in-study mpMRIs).
6. Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
7. Written informed consent by the patient for participation in the study.
8. Patient has an understanding of the English language sufficient to understand written and verbal information about the study and consent process.

E.4

Principal exclusion criteria

1. Prostate volume (PV) <20mL (20g).
2. Previous radiation therapy to the pelvis.
3. Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
4. Use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
5. Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
6. Presence of any other clinically significant lesion (as defined above in inclusion criteria 3), other than the pre-identified lesion for treatment, outside of the planned treatment zone.
7. Inability to tolerate a transrectal ultrasound (TRUS).
8. Known allergy to latex or gadolinium (Gd).
9. Prior rectal surgery preventing insertion of the TRUS probe.
10. Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
11. Any previous injected chemical or injected biological treatment performed on the prostate.
12. Transurethral resection of the prostate (TURP) for symptomatic lower urinary tract symptoms (LUTS) within the 6 months prior to dosing.
13. Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artefact to images).
14. Presence of metal implants/stents in the urethra or any other non-MRI compatible metal objects.
15. Renal impairment with an estimated glomerular filtration rate (GFR) of <35mL/min (unable to tolerate Gd dynamic contrast-enhanced MRI).
16. Use of ANY of the following medications:
• Anticoagulants (e.g., Coumadin, heparin) or platelet inhibitors (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], clopidogrel [e.g., Plavix®]) within 5 days prior to dosing or anticipated for use any time within the first 3 days after dosing or per local guidelines.
• Androgen deprivation therapy will not be permitted during study duration unless the development of metastases (rare) occurred during study follow-up. 5-alpha reductase inhibitors will not be permitted during the study until the post-treatment biopsies have been taken.
17. Any condition that may confound the assessment of safety and tolerability, such as current symptomatic prostatitis; acute or chronic or symptomatic genitourinary infection; or urinary retention requiring catheterisation within 12 months prior to dosing or elevated International Normalized Ratio (INR) >1.5 at the time of dosing.
18. Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the patient or the likelihood that the patient will be unable to complete the study.
19. Unable or unwilling to comply with the requirements of the protocol.
20. Participation in any investigational study within 30 days prior to dosing.

E.5 End points

E.5.1

Primary end point(s)

To assess safety and tolerability of a single and if applicable a second administration of PRX302 which will be described by summarizing AEs, concomitant medications, concomitant procedures and changes from baseline in physical examinations, clinical laboratory tests (including PSA), EF-IIEF, IPSS, UCLA-EPIC Urinary domain, and EQ-5D-5L

E.5.1.1

Timepoint(s) of evaluation of this end point

Proportion of patients with an absence of clinically significant prostate cancer in the targeted area at 24 weeks post-treatment with a single administration of PRX302, as determined by a transperineal targeted biopsy. (Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm.)

E.5.2

Secondary end point(s)

• Proportion of patients with an absence of clinically significant prostate cancer in the targeted area as determined by a transperineal targeted biopsy. (Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm.)
• Proportion of patients with no detectable prostate cancer in the targeted area as determined by a transperineal targeted biopsy.
• Proportion of patients with no detectable prostate cancer in the targeted area as determined by a transperineal targeted biopsy.
• Change from baseline on transperineal targeted biopsy performed of the treated area.
• Proportion of patients with the absence of mpMRI-visible disease in the targeted lesion area.
• Proportion of patients with a reduction in the volume of mpMRI-visible targeted lesion defined as a ≥ 20% volume reduction.
• Ability of mpMRI to predict the presence of residual clinically significant prostate cancer seen on biopsy in the targeted lesion area.
• Change from baseline in mpMRI parameters (e.g., size of lesion, enhancement properties, diffusion weighted properties, T2-weighted characteristics, Grade 1-5 MRI score).
• Change from baseline in serum PSA.
• Change from baseline in serum PSA density (PSA in ng/mL divided by prostate volume [PV] in mL).

E.5.2.1

Timepoint(s) of evaluation of this end point

At 24 weeks post-treatment following a single and if applicable a second administration of PRX302.

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

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

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

E.8.7

Trial has a data monitoring committee

Yes

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

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:

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

After a maximum of 2 administrations of study drug the patients will be monitored as is standard of care with prostate cancer and standard treatments will be offered if necessary

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

2016-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-03

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-11-30

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