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    Summary
    EudraCT Number:2016-000842-79
    Sponsor's Protocol Code Number:IJB-PROS-PROSPERO-2016
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000842-79
    A.3Full title of the trial
    Prospective evaluation of 68Ga-PSMA PET-CT for Recurrence detection of Prostate Cancer and its impact on patient management
    The ProsPERo Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective evaluation of 68Ga-PSMA PET-CT for Recurrence detection of Prostate Cancer and its impact on patient management. The ProsPERo Trial
    A.3.2Name or abbreviated title of the trial where available
    PROSPERO
    A.4.1Sponsor's protocol code numberIJB-PROS-PROSPERO-2016
    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 SponsorInstitut Jules Bordet
    B.1.3.4CountryBelgium
    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 supportLes Amis de l'Institut Jules Bordet
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Jules Bordet
    B.5.2Functional name of contact pointDepartement medecine nucleaire
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard de Waterloo 121
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3225413082
    B.5.5Fax number322541
    B.5.6E-mailcarlos.artigas@bordet.be
    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 name68Ga-(HBED-CC)-PSMA
    D.3.2Product code 68Ga-PSMA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNno proposed INN
    D.3.9.2Current sponsor code68Ga-(HBED-CC)-PSMA_IJB
    D.3.9.3Other descriptive nameGALLIUM(68GA)-(HBED-CC)-(AHX)LYS-CO-GLU
    D.3.9.4EV Substance CodeSUB182637
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number900
    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 Yes
    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
    Males 18 years of age or older with histologically-proven prostate adenocarcinoma and biochemical relapse with rising PSA level after initial treatment with radical curative intent, not yet on palliative systemic treatment and considered for further salvage therapy
    E.1.1.1Medical condition in easily understood language
    Males with prostate cancer and biochemical relapse with rising PSA level after initial treatment
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10068979
    E.1.2Term Imaging procedure
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prospectively evaluate the impact of 68Ga-PSMA-ligand PET-CT (PSMA-PET/CT) on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up (RIW).
    A treatment management decision will be recorded at the urologic tumor board (UTB) before and after the PSMA-PET/CT result. Rate of decision change will be calculated.
    No new prostate cancer therapy is allowed between the signature of the Informed Consent Form (ICF) and the PSMA-PET/CT.
    E.2.2Secondary objectives of the trial
    1)To compare detection rates of PSMA-PET/CT and RIW.
    2)To search for a predictor of a positive PET scan.
    3)To assess diagnostic value of PSMA-PET/CT.
    4)To assess PSA response after targeted treatment for oligometastatic disease.
    5)To evaluate the delay to start of Androgen Deprivation Therapy (ADT) from the UTB decision.
    6)To evaluate the time to PSA progression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age ≥ 18 years old.
    •Histologically-proven prostate adenocarcinoma.
    •Biochemical recurrence after initial treatment with radical curative intent based on PSA values 1:
    a) Following Radical Prostatectomy (RP) +/- Radiotherapy (RT): a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
    b) Following primary RT: PSA value of 2 ng/ml above the nadir.
    c) A continued rise in PSA level despite treatment with curative intent.
    •Patients with negative, inconclusive or oligometastatic disease on the RIW and susceptible to be treated with curative radical intent (salvage treatment).
    RIW exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
    •Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the UTB and available before the PSMA-PET/CT.
    •ECOG performance status ≤ 2.
    •Signed informed consent prior to any study related procedure.
    E.4Principal exclusion criteria
    •Previous malignancy other than PCa (except basocellular or squamous cell skin cancer).
    •Patients previously treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
    •PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.
    •Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L).
    •Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
    •All medical conditions that might interfere with the correct performance of imaging scans.
    •Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)
    E.5 End points
    E.5.1Primary end point(s)
    Changes in treatment management are defined either as:
    •Shift to a different therapeutic strategy (systemic treatment vs surgery vs radiotherapy vs high intensity focused ultrasound vs hormonotherapy vs watchful waiting).
    •Modification of the initial therapeutic strategy (eg. change of surgical approach or change of radiotherapy planning).
    •No change
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the 2nd urologic tumor board (UTB)
    E.5.2Secondary end point(s)
    1.Number of positive scans
    •PSMA only positive
    •RIW only positive
    •Positive in both
    2.Detection rates will be correlated with:
    •PSA value at the time of imaging
    •PSA doubling time
    •Gleason score
    3.Reference diagnosis :
    •Histology when available.
    •Normalisation of PSA level after ablative therapy.
    •Morphological and/or biochemical evolution when no target treatment is given.
    4.A confirmed PSA response is defined as ≥ 30% reduction of the blood level, compared to the baseline value, confirmed by a second PSA value 4 or more weeks later. PSA responses will be evaluated at 1 month after targeted radiotherapy (RT) or surgery and 3 and 6 months after the UTB decision.
    5.ADT free survival: time from UTB to start of ADT treatment during the follow period of 6 months.
    6.Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria:
    •In case of decline from baseline: record time from UTB to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir OR that is ≥25% above the pretreatment PSA value and which is confirmed by a second value 3 or more weeks later.
    •In case of no decline from baseline: PSA increase that is ≥25% and ≥ 2 ng/ml after 3 months if baseline PSA is ≥2 ng/ml. PSA increase that is ≥25% after 3 months if baseline PSA is < 2 ng/ml.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the 2nd urologic tumor board (UTB)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 study will be declared when all the following criteria will have been met:
    -After last visit of the last subject
    -The trial is mature for the analysis (endpoints as defined in the protocol have been collected, if the trial reaches its endpoints).
    -The database has been fully cleaned and frozen for all analyses.
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state75
    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)
    At the discretion of the treating physician according to the standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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