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    Summary
    EudraCT Number:2016-002504-43
    Sponsor's Protocol Code Number:LPC-004
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-06
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2016-002504-43
    A.3Full title of the trial
    A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))
    Viengubai koduotas, dviejų etapų, dozės nustatymo tyrimas, skirtas įvertinti vienkartinės Liproca® Depot injekcijos į prostatą saugumą, toleravimą ir veiksmingumą neišplitusiu prostatos vėžiu sergantiems pacientams, kuriems paskirtas aktyvus stebėjimas ir yra didelis ligos progresavimo pavojus (vėliau vyks atviras tyrimo tęsinys (pasirenkamasis), kurio metu bus atliekama pakartotinė injekcija)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational product Liproca® Depot single injected into the prostate is safe, tolerable and effective in treatment of localized prostate cancer for patients assigned to active surveillance and who are at high risk for disease progression – using a single blind and two-stage dose finding study design followed by an open label extension.
    A.4.1Sponsor's protocol code numberLPC-004
    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 SponsorLIDDS AB
    B.1.3.4CountrySweden
    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 supportLIDDS AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUAB CROWN CRO
    B.5.2Functional name of contact pointRasa Lecickaja
    B.5.3 Address:
    B.5.3.1Street AddressR. Kalantos g. 161
    B.5.3.2Town/ cityKaunas
    B.5.3.3Post codeLT-52315
    B.5.3.4CountryLithuania
    B.5.4Telephone number+37037209 783
    B.5.5Fax number+37037209 763
    B.5.6E-mailrasa.lecickaja@crowncro.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 nameLiproca® Depot
    D.3.2Product code Not applicaple
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraprostatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN2-HYDROXYFLUTAMIDE
    D.3.9.1CAS number 52806-53-8
    D.3.9.2Current sponsor code2-HOF
    D.3.9.3Other descriptive namenot applicaple
    D.3.9.4EV Substance CodeSUB29608
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) 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 No
    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 No
    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
    Asymptomatic localized prostate cancer patients
    E.1.1.1Medical condition in easily understood language
    Asymptomatic localized prostate cancer patients
    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
    Primary objectives:
    •To define the highest tolerable dose of Liproca®Depot for transrectal injection into the prostate

    •To determine the level of Prostate Specific Antigen (PSA) reduction for the doses in Stage II
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    •To determine the effect on PSA as a function of time from injection up to 24 weeks after treatment with Liproca® Depot, at four dose levels
    •To determine the safety and tolerability of a single dose of Liproca® Depot, up to 24 weeks after treatment

    Open-Label Objectives:
    •To determine the time to PSA recurrence (defined as a PSA level exceeding at least 100 % of Baseline value) beyond 24 weeks after treatment with Liproca® Depot
    •To evaluate the safety, tolerability and efficacy of a second treatment of Liproca® Depot 24 weeks after treatment (using the same dose as the initial treatment)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    1.Signed informed consent prior to any study specific procedures being performed
    2.18 - 80 years of age, inclusive
    3.Assigned to Active Surveillance
    4.Histologically confirmed, localized prostate cancer within 24 months of Screening
    5.Gleason score 3+3 or 3+4 with one or more of the following characteristics:
    -PSA ≥ 6.0 µg/L (ng/mL) and PSA density > 0.15
    -PSA ≥ 10.0 µg/L (ng/mL) and ≤ 20 µg/L (ng/mL)
    -Any systematic core > 50% involvement
    -Any PI-RADS 4 or 5 on MRI
    -Any Gleason grade 4
    -Men of African descent
    6.Patient has a negative bone scan within the last 12 months
    7.Patient is able to have an MRI
    8.Prostate volume ≤ 80 mL (measured by MRI within 12 months of Screening or has been scheduled for an MRI prior to Screening)
    9.9.eGFR ≥ 30 mL/min, using the Cockcroft – Gault Equation:

    Creatinine Clearance = [{(140 – age in years) x (weight in kg)} x 1.23]
    serum Creatinine in micromol/l

    Link to eGFR calculator https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation

    10.AST, ALT and ALP ≤ 1.5 times upper limit of normal
    11.Patient must be willing to comply with all study procedures
    12.Patients must agree to the use of medically acceptable methods of contraception during the entire 24 weeks study period including non-hormonal intrauterine device (IUD) or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide), unless the patient and/or their partner has been surgically sterilized

    Open Label Extension Study:
    -Overall safety results are acceptable, as determined by the Investigator and in consult with the Sponsor
    -Subject has consented to participate in the Open Label Extension Study
    E.4Principal exclusion criteria
    Exclusion Criteria
    1.PSA > 20 µg/L (ng/mL)
    2.Previous or ongoing hormonal therapy for prostate cancer
    3.Positive urine culture before treatment with prophylactic antibiotics
    4.Ongoing or previous therapy with finasteride or dutasteride in the last 3 months
    5.Ongoing or previous invasive therapy for benign prostate hyperplasia (BPH) (e.g. TURP, TUMT, HIFU, etc.)
    6.Use of pacemaker or other implanted electronic devices
    7.Metal implant in the pelvis (e.g. hip replacement) that may affect the MRI of the prostate
    8.Allergy to Liproca® Depot and its ingredients
    9.Severe micturition symptoms (I-PSS >15 or residual urine volume > 150 mL) confirmed by repeat measurement or Qmax< 12 mL/s
    10.Ongoing therapy with the anticoagulant Acetyl Salicylic Acid (ASA) (more than 100 mg/day) as preventive anti-thrombotic therapy should be withdrawn temporarily before treatment with Liproca® Depot, as determined by the Investigator. Other anticoagulants should be withdrawn in cooperation with the treating physician
    11.Use of any previous focal prostate cancer treatment, such as transurethral resection, cryotherapy, high intensity frequency ultrasound (HIFU) and/or photodynamic therapy
    12.Concomitant systemic treatment with corticosteroids or immune modulating agents
    13.Known immunosuppressive disease (e.g. HIV, Type II Diabetes). Patients with well controlled Type II Diabetes may be included, as determined by Investigator
    14.Simultaneous participation in any other study involving an investigational product or device, or having participated in a prostate cancer study within the last 12 months prior to starting treatment with Liproca® Depot
    15.Infection in WHO Risk Group 2, 3 or 4 (see Appendix A)

    Open Label Extension Study:
    Same exclusion criteria as above
    E.5 End points
    E.5.1Primary end point(s)

    •The highest tolerable dose of Liproca® Depot
    •Responder rate, absolute levels and % decrease in Prostate Specific Antigen (PSA) 20 weeks after treatment for the doses of Liproca® Depot selected in Stage II. A responder is defined as a patient with a PSA decrease of at least 15%
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 20 (5 months)
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    •Responder rate, absolute levels and % decrease of PSA level at Week 8, 16, 20 and 24, and PSA nadir. A responder is defined as a patient with a PSA decrease of at least 15%
    •MRI evaluation of prostate volume (PV) measured as % decrease versus Baseline and as absolute values
    •Evaluation of lesions (PI-RADS score) 20 weeks after treatment
    •Quality of Life (QoL) assessment at Baseline, Week 8, 16, 20 and 24 after treatment

    Safety Endpoints
    •Vital signs, chemistry and haematology data, urinary flow (Qmax), residual urine volume, International Prostate Symptom Score (I-PSS), and adverse events, accumulated over the 14 day period after treatment
    •Micturition status (I-PSS) at Week 8, 16 and 24
    •Adverse events will be reported and followed until resolved or until, in the Investigator’s opinion, the condition has become stable and is unlikely to change further
    •Testosterone levels at Baseline, Week 8 and 24 after treatment

    Pharmacokinetics
    •Pharmacokinetic (PK) levels of 2-hydroxyflutamide at Baseline, Hour 2, Day 2, 4, 7 and 14, Week 8 and at End of Study
    •Pharmacokinetics will be evaluated in all subjects in Stage I and a subset of subjects in Stage II. Pharmacokinetics will be characterized using standard PK variables such as T1/2, Tmax, Cmax, AUC

    Open-Label Endpoints:
    •PSA level at Week 32, 40 or 48, or until PSA recurrence (defined as a PSA level exceeding at least 100 % of Baseline value)
    •PSA level at 8 Weeks and 24 Weeks after the second treatment with Liproca® Depot
    •All adverse events (AEs) over the full study period after the second treatment and followed until all being resolved
    •MRI evaluation (including prostate volume) 24 Weeks after the second treatment with Liproca® Depot for only those subjects presenting with a target lesion at Visit 1 (Screening) or Visit 9 (Week 20) in the Single Dose Study
    •Histopathology (prostate biopsy) 24 Weeks after the second treatment with Liproca® Depot (at the Investigator’s discretion or standard of care)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PSA decrease at 2, 4, 5, 6 months
    -prostate volume % decrease, at 5 months
    -QoL assesment at baseline, 2, 4, 5, 6 months
    -safety at 14 days, 2,4, 6 months
    -PK subset at the highest dose level at baseline, hour 2, Day 2,4,7,14 and 2, 6 months
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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
    Different doses of PR1 given; a)35%, b)45% of the prostate volume or fixed doses c)16mL d)20mL
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Finland
    Lithuania
    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
    LVLS
    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 months9
    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 months9
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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 (normal hospital treatment procedures)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-22
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