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    Summary
    EudraCT Number:2015-003720-32
    Sponsor's Protocol Code Number:SPECTRE2015
    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:2016-03-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003720-32
    A.3Full title of the trial
    Combined Suppression Of Cholesterol Bioavailability And Androgen Deprivation Therapy To Treat Castration Resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SPECTRE
    A single arm Phase II study to test if adding statins to hormone treatment will result in better cancer control in patients with hormone resistant prostate cancer.
    A.3.2Name or abbreviated title of the trial where available
    SPECTRE
    A.4.1Sponsor's protocol code numberSPECTRE2015
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN16951765
    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 SponsorNHS Greater Glasgow and Clyde
    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 organisationProstate Cancer UK
    B.5.2Functional name of contact pointDr Reena Morjaria
    B.5.3 Address:
    B.5.3.1Street AddressFourth Floor, The Counting House, 53 Tooley Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 2QN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033107000
    B.5.5Fax number02033107107
    B.5.6E-mailreena.morjaria@prostatecanceruk.org
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    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 Information not present in EudraCT
    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 nameAtorvastatin
    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 INNatorvastatin calcium trihydrate
    D.3.9.1CAS number 344423-98-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatorvastatin calcium trihydrate
    D.3.9.1CAS number 344423-98-9
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatorvastatin calcium trihydrate
    D.3.9.1CAS number 344423-98-9
    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 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) 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
    Castration Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which has become resistant to hormone treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10007113
    E.1.2Term Cancer 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
    To explore the impact of atorvastatin on androgen receptor signalling in castration-resistant prostate cancer.
    E.2.2Secondary objectives of the trial
    To study the impact of atorvastatin on the status of intermediates of androgen biosynthesis pathway in castration-resistant prostate cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically proven adenocarcinoma of the prostate (patients may or may not have evidence of metastatic disease)
    2) Disease progression despite on-going castration therapy (either using LHRH analogue or prior surgical orchiectomy) as judged by rising serial PSA measurements: This will be based on a series of at least 3 readings each taken at least 7 days apart. The 3rd reading must be ≥2 ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (i.e. the 3 readings do not need to be consecutive). In patients who have received prior bicalutamide, flutamide or nilutamide, PSA progression must be proven after withdrawal of this drug.
    3) Castrate levels of serum testosterone (<1.7 nmol/l)
    4) Ongoing castration therapy (either LHRH analogue or prior orchiectomy).
    5) No therapy with statins or other cholesterol-lowering drug during a 2-month period prior to initiation of trial medication.
    6) Male aged 18 or over
    7) Life expectancy greater than 6 months
    8) Adequate hepatic, bone marrow coagulation and renal function as defined by the following criteria:
    a. Haemoglobin > 9.0 g/dL
    b. Platelets > 100 x 109L
    c. Creatinine <2 x ULN
    d. Hepatic function: total bilirubin ≤ 2 x ULN; ALT and AST ≤ 3 x ULN
    e. Creatine kinase ,≤ 5 x ULN
    f. Fasting glucose ≤ 5.6 mmol/L
    g. Prothrombin time ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
    h. Platelets ≥ 100

    9) Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
    10) Ability to swallow oral medications
    11) Willing to undergo two biopsies for research purposes with a lesion (either primary or secondary) amenable to biopsy.
    E.4Principal exclusion criteria
    1) Uncontrolled hypertension (defined as systolic ≥ 170mmHg and/or diastolic ≥ 100 mmHg despite optimal therapy)
    2) The requirement for strong opiates to control cancer related pain; codeine and tramadol are
    permitted
    3) NYHA class III or IV heart failure or Childs-Pugh liver failure class B or worse
    4) Patients with symptomatic or radiographic disease progression (Note: Imaging studies will not be conducted specifically to meet this criterion but only if clinically indicated in accordance with standard of care)
    5) Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the trial
    6) History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol, or any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule.
    7) Administration of any investigational drug within 28 days of receiving the first dose of trial treatment
    8) Major surgery within 28 days prior to trial entry
    9) Active condition which affects drug absorption (e.g. prior gastrectomy or active peptic ulcer disease)
    10) Planned change in systemic therapy for 6 weeks after study initiation
    11) Planned requirement for radiotherapy or surgery for 6 weeks after study initiation
    12) Prior hypersensitivity to atorvastatin or its constituents
    13) Requirement for on-going anti-coagulant therapy (including heparins and warfarin)
    14) Prior systemic therapy for CRPC with cytotoxic chemotherapy, abiraterone or enzalutamide. For clarity, docetaxel for non-castration resistant disease is permitted.

    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the change in PSA levels from baseline during the treatment period, where a responder is any patient which achieves a ≥50% drop from baseline in PSA levels at any time over the 6-week period of statins treatment (PSA response).
    E.5.1.1Timepoint(s) of evaluation of this end point
    As above, the evaluation period will be the six week treatment period.
    E.5.2Secondary end point(s)
    1)Maximum percentage drop in PSA level
    2)Maximum change in testosterone level
    3)Change in adrenal steroid DHEA (dehydroepiandrosterone) levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation period will be the six week treatment period, during which patients are evaluated weekly.
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 trial will be the date of the last data capture or when the last patient attends their last follow-up visit for the trial, whichever is the latest.
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    They will be managed accordingly to their clinical need and further statin medication may be prescribed if thought to be clinically appropriate.
    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 Decision2016-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-01
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