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    Summary
    EudraCT Number:2014-001784-13
    Sponsor's Protocol Code Number:ISRCTN91422391
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 number2014-001784-13
    A.3Full title of the trial
    PROVENT: A randomised, double blind, placebo controlled feasibility study to examine the clinical effectiveness of aspirin and/or Vitamin D3 to prevent disease progression in men on active surveillance for prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROVENT: A randomised, placebo controlled feasibility study to examine the effectiveness of aspirin and/or Vitamin D to prevent disease progression in men undergoing monitoring for prostate cancer

    A.3.2Name or abbreviated title of the trial where available
    PROVENT: Version 1.0
    A.4.1Sponsor's protocol code numberISRCTN91422391
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN91422391
    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 SponsorQueen Mary University of 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 supportBarts and the London Charity
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportMerck Serono GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBayer Healthcare Pharmaceuticals
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportHologic Gen-Probe
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMyriad Genetics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarts CTU, Queen Mary University of London
    B.5.2Functional name of contact pointLiz Pinney
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Cancer Prevention, Wolfson Institute, Charterhouse Square,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1M 6BQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078823521
    B.5.5Fax number02078823890
    B.5.6E-maill.pinney@qmul.ac.uk
    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 Aspirin 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAspirin 100mg
    D.3.4Pharmaceutical form Gastro-resistant tablet
    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 INNacetylsalicylic acid
    D.3.9.1CAS number CAS 50-78-2
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameaspirin
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number100
    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.IMP: 2
    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 Vigantol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameVitamin D
    D.3.4Pharmaceutical form Oral drops
    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 INNcholecalciferol
    D.3.9.1CAS number 8017-28-5
    D.3.9.3Other descriptive nameVitamin D 3 - IUPAC Name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E... CAS
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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.IMP: 3
    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 Aspirin 300mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH,
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAspirin 300mg
    D.3.4Pharmaceutical form Gastro-resistant tablet
    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 INNacetylsalicylic acid
    D.3.9.1CAS number ASA 50-78-2
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameAspirin
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number300
    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 placeboConcentrate and solvent for suspension for injection
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for suspension for injection
    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
    Prostate cancer disease progression
    E.1.1.1Medical condition in easily understood language
    Prostate cancer that may develop from a low to intermediate risk form of the disease into a more aggressive form
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The principal research objective for this study is to demonstrate the acceptability and feasibility of recruiting to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an active surveillance programme for prostate cancer.
    E.2.2Secondary objectives of the trial
    The secondary research objectives for this study are:

    1. To report response to treatment as determined by magnetic resonance imaging (MRI) of the prostate and to assess consistency of reporting

    2. To report cancer progression based on an increase in serum PSA (Prostate Specific Antigen)

    3. To report cancer progression based on an increase in prostate cancer grade or volume, and to assess consistency of reporting

    4. To report adverse reactions and/or allergy to aspirin and/or Vitamin D3

    5. To assess various laboratory tests, both standard tests and specific research tests, to see how they may help us identify aggressive prostate cancer earlier
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male subjects aged 16 years or over with an estimated life expectancy of more than three years

    2. Willing and able to provide written informed consent

    3. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy)

    4. All subjects must have Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified

    5. Histologically confirmed prostate cancer following prostate biopsy in men opting for Active Surveillance as their primary cancer therapy

    6. Serum calcium (corrected) less than or equal to 2.65mmol/l

    Prostate cancer criteria for inclusion:
    1. Gleason score 6 or 7
    2. Clinical and radiological stage <T3
    3. Serum PSA < or = 15.0 ng/ml
    4. Less than 10mm of cancer in a single core

    Patients must have undergone a multiparametric MRI prior to study enrolment together with a prostate biopsy targeting any MRI observed lesions within 12 months of study enrolment.
    E.4Principal exclusion criteria
    1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)

    2. Current enrolment in an investigational drug, device or other clinical research study, or participation in such a study within 30 days of randomisation

    3. Current daily use of aspirin or NSAIDs; or daily dietary supplements/medication containing more than 400 IU (10 micrograms per day)Vitamin D; or chronic use (defined as > 6 months continuous daily use) of either aspirin or Vitamin D within two years of study enrolment

    4. Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride

    5. Not willing to comply with the procedural requirements of this protocol, including repeat prostate biopsies

    6. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen

    7. Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease

    8. Haemophilia or other bleeding diatheses

    9. Prior history of renal stone disease

    10. Chronic renal disease (≥stage 4)

    11. Known hypercalcaemia (corrected serum calcium >2.65 mmol/l)or untreated hyperparathyroidism

    12. Any bowel condition that would make repeat transrectal biopsy hazardous or difficult to perform e.g. recto-urethral fistula, or prior bowel surgery such as abdomino-perineal resection.

    13. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years

    14. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration

    15. Severe Asthma

    16. G6PD deficiency

    17. Pre-existing macular degeneration

    18. All contraindications to aspirin and Vitamin D, including concomitant therapy with any medication that may interact with aspirin or Vitamin D (see section 4.10)

    19. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)
    E.5 End points
    E.5.1Primary end point(s)
    The PROVENT study is a feasibility study to determine whether men with prostate cancer managed with active surveillance are willing to be enrolled into a randomised placebo-controlled chemoprevention trial evaluating aspirin and Vitamin D.

    Therefore the primary outcome measure of this feasibility study is patient recruitment over the 18 month study period. Screening logs and Case Report Forms (CRFs) will be utilised to measure patient recruitment.



    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of the study is the rate of patient recruitment. This will be captured by reporting the proportion of eligible patients that join the trial over the 18-month trial recruitment period.

    After a recruitment period of 9 months, the Data Monitoring Committee will identify whether study recruitment has been adequate, i.e. an average recruitment rate of 6 patients per month, and if monitoring of 50% of the feasibility group shows minimal adverse effects in any arm of the trial, this information will be used to justify the main trial.
    E.5.2Secondary end point(s)
    The secondary endpoints for PROVENT are:

    To report response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate. Disease progression being defined as the development of a lesion on multi-parametric imaging where no MRI lesion was identified on screening MRI, or alternatively, an MRI scan that demonstrates that a lesion identified on screening MRI has increased or decreased in volume by greater than 33%.

    To report biochemical disease progression - defined as a 50% increase in serum PSA at 12 months from baseline.

    To report histological disease progression - defined as an increase in Gleason scores from:

    Gleason 3+3 to Gleason score 7 or higher
    Gleason 3+4 (score 7) to 4+3 (score 7) or
    Gleason 4+3 to a higher score

    Or a 50% increase in maximum cancer core length (MCCL)


    To report toxicity and/or allergy to both aspirin and Vitamin D.

    To evaluate an association between androgens and disease progression

    To evaluate markers of disease progression

    E.5.2.1Timepoint(s) of evaluation of this end point
    MRI detected disease progression together with biochemical and histological disease progression will be captured 12 months after study entry.

    All trial patients will undergo repeat MRI imaging and prostate biopsy at 12 months allowing comparison with baseline investigations.

    All patients will undergo sequential PSA testing at 3 monthly intervals. To capture final outcome a mixed linear model will be applied on log (1+PSA) to test for dose-by-time interactions.

    Toxicity and/or allergy will be captured continuously throughout the study period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Recruitment feasibility and patient acceptability
    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) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned5
    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 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 - will be the end of the active phase
    LPLDI - Last Patient Last Data Item will be the end of the non-interventional follow up period, which will be LVLS plus 10 years
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 102
    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)
    If this feasibility study has a positive outcome, and funding is secured for the full trial, patients may be able to transfer directly into a phase III study.

    Otherwise, all patients that have participated in the trial will exit the trial and continue on a standard of care clinical pathway as recommended by the National Institute for Cancer and Health Excellence (NICE). This pathway will include serial Prostate Specific Antigen monitoring together with
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRN: North Thames
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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