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    Summary
    EudraCT Number:2010-021900-93
    Sponsor's Protocol Code Number:CLIN1001 PCM301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-03
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-021900-93
    A.3Full title of the trial
    A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for low risk localised prostate cancer compared to Active Surveillance
    A.4.1Sponsor's protocol code numberCLIN1001 PCM301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSTEBA BIOTECH SA
    B.1.3.4CountryLuxembourg
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTOOKAD® Soluble
    D.3.2Product code WST11
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPadeliporfin
    D.3.9.1CAS number 886845-72-3
    D.3.9.2Current sponsor codeWST11
    D.3.9.3Other descriptive namePalladium Bacteriopheophorbide Monolysotaurine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeWST11 originates from bacterial culture. Because of the three synthesis and purification steps after the Bacteriochlorophyll a extraction, it is classified as a small-molecule pharmaceutical drug.
    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
    Low-risk prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble VTP compared to men on active surveillance.
    E.2.2Secondary objectives of the trial
    To assess the impact of TOOKAD® Soluble VTP on the rate of absence of significant cancer (key secondary objective).

    To determine the differences between men who undergo TOOKAD® Soluble VTP and men on active surveillance with regard to:
    - the rate of additional prostate cancer therapy
    - the overall cancer burden in the prostate
    - Prostate Specific Antigen
    - the rate of adverse events
    - incontinence, erectile dysfunction, urinary and rectal discomfort
    - the overall quality of life and prostate-related anxiety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Low risk prostate cancer diagnosed using transrectal ultrasound guided biopsy using a minimum of 10 cores or equivalent, showing:
    • Clinical stage up to T2a (pathological or radiological up to T2c disease permitted),
    • Gleason 3 + 3 prostate adenocarcinoma,
    • A maximum of three (3) cores positive for cancer,
    • A maximum cancer core length of 5 mm in any core.
    2) Serum prostate specific antigen (PSA) of 10 ng/mL or less.
    3) Prostate volume more than 30 cc and less than 60 cc.
    4) Male subjects aged 18 years or older.
    E.4Principal exclusion criteria
    1) Unwillingness to accept randomisation to either of the two arms of the study
    2) Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
    3) Life expectancy less than 5 years.
    4) Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure such as:
    4.1) Any condition or history of illness or surgery that in the opinion of the Investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., active inflammatory bowel disease which may predispose to rectal fistula formation, cardiac or respiratory disease precluding general anaesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure);
    4.2) Medical conditions which preclude the use of general anaesthesia.
    4.3) A history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation.
    4.4) Hormonal manipulation (excluding 5 alpha reductase inhibitors) or androgen supplements within the previous 6 months.
    4.5) History of urethral stricture disease.
    4.6) History of acute urinary retention within 6 months of study entry.
    4.7) Men who have an absolute need for the following medication which have potential photosensitising effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics and griseofulvin).
    4.8) Men who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin) which cannot be withdrawn during the 10 days prior to the VTP procedure.
    4.9) Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) and blood disorders (clinician judgement).
    4.10) A history of sun hypersensitivity or photosensitive dermatitis.
    5) Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
    6) Contra-indication to MRI (e.g., pacemaker), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).
    E.5 End points
    E.5.1Primary end point(s)
    Failure of treatment due to progression of cancer from low to moderate or higher risk over the 24 month follow-up. Moderate or higher risk is defined as the observation of:
    - More than 3 cores positive for cancer when considering all biopsies during follow-up of study;
    - or any Gleason primary or secondary pattern 4 or more;
    - or at least one cancer core length greater than 5 mm;
    - or PSA>10ng/mL in 3 consecutive measures;
    - or any metastasis.

    Positive cores are considered whenever the length of cancer in the core is >1 mm in size. Histological changes are assessed using biopsies taken under the guidance of transrectal ultrasound at 12 and 24 months or at anytime time during follow-up.

    A panel blinded to the exposure status reviews the histological reports of all patients, whether reported positive or negative for cancer, and all the PSA data.
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Active surveillance population
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 400
    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 Decision2010-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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