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    Summary
    EudraCT Number:2014-003386-22
    Sponsor's Protocol Code Number:PRX302-2-07
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-10
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-003386-22
    A.3Full title of the trial
    A Single Centre, Open Label, Phase IIa Study, Evaluating the Safety and Tolerability 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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PRX302 (protein) injection directly into the prostate to treat prostate cancer that has not spread beyond the prostate
    A.3.2Name or abbreviated title of the trial where available
    Intraprostatic PRX302 injection to treat localised prostate cancer
    A.4.1Sponsor's protocol code numberPRX302-2-07
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSophiris Bio Corp
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSophiris Bio Corp
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSophiris Bio Corp
    B.5.2Functional name of contact pointAllison Hulme
    B.5.3 Address:
    B.5.3.1Street Address1258 Prospect Street
    B.5.3.2Town/ cityLa Jolla, CA 92037
    B.5.3.4CountryUnited States
    B.5.4Telephone number001858255-4702
    B.5.5Fax number001858412-5693
    B.5.6E-mailallison@sophiris.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nametopsalysin
    D.3.2Product code PRX302
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraprostatic use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePRX302 is a 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.1.1Medical condition(s) being investigated
    Prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety and tolerability of PRX302 when used to selectively target and focally ablate histologically proven, clinically significant localised low to intermediate prostate cancer that is associated with an MRI lesion.
    E.2.2Secondary objectives of the trial
    2. To evaluate the potential efficacy of PRX302 to selectively target and focally ablate histologically proven, clinically significant, localised low to intermediate prostate cancer that is associated with an MRI lesion, as assessed by biopsy (histological), imaging (MRI) and PSA outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 prostate cancer of maximum Gleason Score 7 (3+4 or 4+3)
    • In the presence of Gleason sum of 7, the maximum cancer core length must be 10mm or less
    • In the presence of Gleason sum of 7 there is no minimum cancer core length involvement
    • In the presence of Gleason patterns 3+3 the minimum cancer core length must exceed 3mm.
    4. Radiological stage T1-T2 N0 Mx/M0 disease.
    5. A visible lesion on mpMRI that is accessible to PRX302 transperineal injection. mpMRI to be obtained at the screening visit or within 3 months prior to dosing.
    6. Transperineal prostate biopsy (template mapping and/or targeted) within 12 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.4Principal exclusion criteria
    1. Previous radiation therapy to the pelvis.
    2. Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
    3. Use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
    4. Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
    5. Presence of Gleason score >7 and/or maximum cancer core length involvement of >3mm outside of the planned treatment zone.
    6. A tumour within the prostate not visible on mpMRI.
    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. Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, thermal or microwave therapy to treat cancer of the prostate.
    11. Transurethral resection of the prostate (TURP) for symptomatic lower urinary tract symptoms within the 6 months prior to dosing.
    12. Not fit for major surgery as assessed by a Consultant Anaesthetist.
    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 30-week 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.5.1Primary end point(s)
    The safety and tolerability of PRX302 will be assessed by recording adverse events, concomitant medications, physicial examinations, baseline medical conditions, vital signs, clinical laboratory tests, urinalysis, PSA, changes in the IIEF, IPSS, UCLA-EPIC Urinary domain and FACT-P.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be monitored throughout the study with assessments carried out at Screening and Visit 1 through Visit 7.
    E.5.2Secondary end point(s)
    The efficacy of PRX302 will be assessed by biopsy (histological), imaging (MRI) and PSA outcomes.
    Although the primary objective is to assess safety and tolerability, the key efficacy variable of interest is the successful ablation of the targeted area, defined as the absence of clinically significant prostate cancer in the targeted area as determined by a transperineal targeted biopsy performed 24 weeks post treatment. Other efficacy evaulations will include, proportion of men with the absence of MRI visible disease, proportion of men with a reduction in the size of MRI visible lesion and pilot data on the ability of MRI to predict presence of residual/recurrent clinically significant prostate cancer on biopsy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRI will be conducted at 2, 12 and 24 weeks. PSA testing will be conducted at Screening, 12 and 24 weeks and Transperineal biopsy will be undertaken at 24 weeks.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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. The experimental intervention takes place once. There is therefore no need to continue provision to participants
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-11
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