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    Summary
    EudraCT Number:2019-001365-32
    Sponsor's Protocol Code Number:19CX5006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 number2019-001365-32
    A.3Full title of the trial
    IP4- CHRONOS: Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IP4-CHRONOS: Comparative Health Research Outcomes of NOvel Surgery in prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    IP4- CHRONOS
    A.4.1Sponsor's protocol code number19CX5006
    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 SponsorImperial Joint Research Compliance Office
    B.1.3.4Country
    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 supportProstate Cancer UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointProfessor Hashim Ahmed
    B.5.3 Address:
    B.5.3.1Street Address5L28, Laboratory Block
    B.5.3.2Town/ cityCharing Cross Campus
    B.5.3.3Post codeW6 8RP
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailhashim.ahmed@imperial.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 Finasteride
    D.2.1.1.2Name of the Marketing Authorisation holderAurobindo Pharma limited
    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 nameFinasteride
    D.3.4Pharmaceutical form 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 INNfinasteride
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 Bicalutamide
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    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 nameBicalutamide
    D.3.4Pharmaceutical form Coated 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 INNbicalutamide
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.2Term Adenocarcinoma of prostate
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our initial CHRONOS trial will be a pilot study. If successful, we will apply for funding for a full main study which will run through if and when funding is approved. We have therefore described the objectives for both phases of CHRONOS, and for both CHRONOS-A and CHRONOS-B.

    Pilot study:
    1)To determine patient acceptance to randomisaton
    2) To coniduct an embedded qualitative study of patient and clinician acceptance and experience of the linked RCT CHRONOS design
    3) To establish the feasibility of an economic evaluation alongside the main trial
    4) To determine the acceptability and completeness of resource use and utility measures (EQ- 5D- 5L)
    5) To identify the relevant NHS and non-NHS resource use to be collected alongside the main trial
    6) To identify the relevant items to populate the Cost and Consequences framework
    7) To perform preliminary analysis of pattern of missing data


    Main study:
    CHRONOS A: To evaluate cancer control rates of focal therapy compared to standard of care
    E.2.2Secondary objectives of the trial
    Disease Control
    To determine the histological, biochemical and oncological disease control for men undergoing radical therapy, focal therapy with neo/adjuvant treatments

    Adverse events and functional outcomes
    To determine the adverse events and functional outcomes after radical therapy, focal therapy or focal therapy with neo/adjuvant treatments

    Health Economics
    To establish the NHS costs of the different interventions
    To determine the Cost per QALYs (CUA), cost per PFS/FFS (CEA) and cost and consequences (CCA)
    To determine acceptability and completeness of resource use and utility measures (EQ-5D-5L)

    Qualitative
    Analyse the patient experience of consent and recruitment, including reasons for declining participation.
    To analyse participants' motivation to accept randomisation to and compliance with an intervention, which may or may not include neoadjuvant and adjuvant treatments.
    To review patients' understanding and experience of each trial arm
    To review patients' experience of tox
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Prostate cancer confirmed on biopsy of Gleason 6 or Gleason 7 overall
    2) Serum PSA (prostate specific antigen) less than or equal to 20ng/ml
    3) Stage </= (radiological) T3aN0M0 or </= (clinical rectal examination)T2N0M0
    4) Minimum age of 18 years of age
    5) Clinically fit enough to undergo all procedures listed in the trial that the patient has been been enrolled into
    E.4Principal exclusion criteria
    1) Previous prostate cancer treatment
    2) Life expectancy less than 10 years
    3) Unable to consent to participation in the trial
    4) Previous or current use of current LHRH agonist or LHRH antagonist or anti-androgen use in CHRONOS-B
    5) Less than 6 months of discontinuation of 5 alpha-reductase inhibitor use in CHRONOS-B
    E.5 End points
    E.5.1Primary end point(s)
    Pilot Phase:
    To determine patient acceptance to randomisation
    To conduct an embedded qualitative study of patient and clinician acceptance and experience of the linked RCT CHRONOS design.
    To establish the feasibility of an economic evaluation alongside the main trial
    To determine acceptability and completeness of resource use and utility measures (EQ-5D-5L)
    To identify the relevant NHS and non-NHS resource use to be collected alongside the main trial
    To identify the relevant items to populate the Cost and Consequences framework
    To perform preliminary analysis of pattern of missing data


    Main Phase:
    CHRONOS A: to evaluate PFS (progression free failure) rates of focal therapy alone compared to radical therapy (radiotherapy or surgery) in the treatment of non- metastatic clinically significant prostate cancer.
    CHRONOS B: To evaluate failure free survival (FFS) rates of focal therapy alone compared to focal therapy combined with other therapies as a neoadjuvant and/or adjuvant strategy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients enrolled within the pilot phase will be followed up for a minimum of 3 months. Should the study continue to the main phase all patients (including those enrolled during the pilot) will continue follow up over a total of 60 months. The trial may be terminated early if determined by the Trial Steering Committee, in which case patients will continue with standard of care follow up and management as per their local hospital policy.
    E.5.2Secondary end point(s)
    1) Determine the adverse events associated with radical therapy, focal therapy and focal therapy with neo/adjuvant treatments.
    2) Determine the cost per QALY, cost per progression/ failure free survival and cost and consequences
    3) To estimate the incremental cost per quality adjusted life year (QALYs) gained over the estimated lifetime of participants for focal therapy compared to radical therapy
    4) To estimate the incremental cost per quality adjusted life year (QALYs) gained over the estimated lifetime of participants for focal therapy compared to focal therapy with a neoadjuvant and/or adjuvant strategies
    5) Patient experience of consent and recruitment, including reasons for declining participation
    6) Participants' motivation to accept randomisation to and compliance with an intervention, which may or may not include neoadjuvant and adjuvant treatments.
    7) Patients' understanding and experience of each trial arm
    8) Patients' experience of toxicities focusing on erectile dysfunction and urinary symptoms
    9) Patients' attitudes to the predicted survival rate
    10) Potential improvements to recruitment processes
    11) To evaluate cancer infiltrating immune cells and immune gene signatures following ablation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicities will be evaluated throughout the follow-up period.
    Progression/ failure free survival will be evaluated throughout the 5 year follow up period, and specific analysis wlil be determined at 1 year in patients undergoing focal therapy.
    Determination for reasons to decline enrolment into the study will be as close to declining visit as possible.
    All other end points will be evaluated over the 5 year follow-up period.
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Control arm in CHRONOS-A: radical therapy; Control arm in CHRONOS-B: focal therapy alone
    E.8.2.4Number of treatment arms in the trial5
    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 concerned10
    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
    The end of the trial will be marked by the completion of the study report so that all study outcomes can be addressed. However, the trial may end early upon recommendation of the Trial Steering Committee.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 state2450
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2450
    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)
    As the interventions are one-offs and do not continue long term this is not relevant. All treatment options, in the case of failure of cancer control, will be discussed with patients at multidisciplinary team meetings.
    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 Decision2019-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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