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    Summary
    EudraCT Number:2009-012405-18
    Sponsor's Protocol Code Number:09/0221
    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:2010-03-15
    Trial results Removed from public view
    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 number2009-012405-18
    A.3Full title of the trial
    Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer population
    A.3.2Name or abbreviated title of the trial where available
    MRI in Primary Prostate cancer after Exposure to Dutasteride (MAPPED)
    A.4.1Sponsor's protocol code number09/0221
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Clinical trial IMP material will be used.
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDutasteride
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDutasteride
    D.3.9.1CAS number 164656-23-9
    D.3.9.3Other descriptive nameAvodart
    D.3.10 Strength
    D.3.10.1Concentration unit Ci/mg curie(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily for six months result in a change in volume of prostate cancer, as assessed by MRI (T2 weighted)?
    E.2.2Secondary objectives of the trial
    In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily result in:

    1. Change in volume of prostate cancer as determined by each of a) gadolinium enhanced b) diffusion weighted MRI after 6 months of dutasteride (Avodart) 0.5mg compared to placebo.
    2. Change in volume of prostate cancer as determined by each of a) T2 weighted MRI b) gadolinium enhanced MRI c) diffusion weighted MRI after 3 months of dutasteride (Avodart) 0.5mg compared to placebo.
    3. Changes in MR characteristics of prostate cancer (perfusion, cell density) between baseline and six months in men on dutasteride (Avodart) 0.5mg compared to placebo.
    4. Change in volume of prostate cancer as assessed by HistoScan transrectal ultrasound between baseline and six months.
    5. An association between the measured prostate cancer volumes on MRI with the measured prostate cancer volumes on HistoScan at baseli
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Men with low risk prostate cancer: Gleason sum 6 or less, PSA less than 15 ng/ml, T1c to T2a
    • Measurable disease on MRI of at least 0.2 cc, based on planimetry volume
    • Biopsy proven disease within 2 years of screening visit
    • Able to swallow and retain oral medication
    • Able and willing to participate in the study for its duration
    • Able to read and write (health outcomes questionnaires are written)
    • Able to understand instructions related to study procedures and give written informed consent.
    E.4Principal exclusion criteria
    Exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:

    1. Subject has ever been treated for prostate cancer with any of the following:
    • Radiotherapy (external beam or brachytherapy)
    • Chemotherapy
     Surgery
    • Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, DES)
    • Oral glucocorticoids
    • GnRH analogues (e.g., leuprolide, goserelin)

    2. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one.

    3. Current and/or previous use of the following medications:
    • Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 12 months prior to study entry are excluded.
    • Any other investigational 5α-reductase inhibitors within the past 12 months.
    • Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
    • Drugs with antiandrogenic properties within the past 6 months (e.g., spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents)
    NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the CRF.
    *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study

    4. Contra indication on gadolinium enhanced MRI:
    inability to see tumour focus of >/= 0.2cc on T2 sequences
    Previous allergic reaction to gadolinium
    Serum creatinine > upper limit normal
    Incompatible pacemaker
    Metal fragments in eyes
    Hip replacements which give artefact with prostate /pelvis views
    Any artefact or condition which reduces image quality of MRI (eg inability to keep still).

    5. Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of involvement.

    6. Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.

    7. Any unstable serious co-existing medical condition(s) including but not limited to: myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.

    8. Abnormal liver function test (greater than 2 times the upper limit of normal) for
    • alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline
    • phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.

    9. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2, as given by UCLH laboratories, due to the risk of a deterioration in renal function with MRI contrast.

    11. History of another malignancy within five years that could affect the diagnosis of prostate cancer.

    12. History or current evidence of drug or alcohol abuse within the last 12 months which might confound the results of the study or pose additional risk to the subject.
    13. Known hypersensitivity to any 5α-reductase inhibitor, soya, peanut, or any other excipients; or to any drug chemically related to dutasteride.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is percentage change in volume of prostate cancer as assessed by T2 weighted MRI at baseline and six 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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned1
    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
    Completion of all trial procedures by participants (follow up and results obtained)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    There are no plans to use dutasteride outside of it's licensed indication, once the study has finished.
    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 Decision2010-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-03
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