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    Summary
    EudraCT Number:2016-001815-19
    Sponsor's Protocol Code Number:Ga-68-PSMA-11
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-15
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-001815-19
    A.3Full title of the trial
    An open-label, single-arm, rater-blinded, multicenter phase 1/2 study to assess safety and diagnostic accuracy and radiotherapeutic implications of pre-operative Ga-68-PSMA-11 PET/CT imaging in comparison to histopathology, in newly-diagnosed prostate cancer (PCA) patients at high risk for metastasis, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in male patients with newly diagnosed prostate cancer to assess the accuracy of an imaging tracer at diagnosing prostate cancer, in comparison to standard prostate biopsy. In addition, the study will collect additional data on the tracers safety, look at the possible ability in the tracer detecting cancer spread to nearby bone and look at the tumour uptake of the tracer.
    A.3.2Name or abbreviated title of the trial where available
    Ga-68-PSMA-11 in high-risk prostate cancer
    A.4.1Sponsor's protocol code numberGa-68-PSMA-11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03362359
    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 SponsorDeutsches Krebsforschungszentrum (DKFZ), Stiftung des öffentlichen Rechts
    B.1.3.4CountryGermany
    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 supportDeutsches Krebsforschungszentrum (DKFZ) Heidelberg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.
    B.5.2Functional name of contact pointDr Volker Meyer
    B.5.3 Address:
    B.5.3.1Street AddressBlasewitzer Strasse 78-80
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number+493512144417
    B.5.5Fax number+493512144415
    B.5.6E-mailvolker.meyer@abx-cro.com
    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-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
    D.3.2Product code Ga-68-PSMA-11
    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 INN68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
    D.3.9.2Current sponsor code68Ga-PSMA-11
    D.3.9.3Other descriptive name68GA-PSMA HBED-CC
    D.3.9.4EV Substance CodeSUB171041
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number6
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer (PCA) with high risk of metastasis.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer (PCA) with high risk of spreading to surrounding bone, tissue or organs
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    1. To assess the ability of Ga-68-PSMA-11 PET/CT imaging to detect prostate cancer tissue within
    a. the prostate gland on level of quadrant (or octant if possible) and
    b. pelvic lymph node metastases on level of 8 defined sub-regions.
    2. To assess the clinical safety of Ga-68-PSMA-11.
    E.2.2Secondary objectives of the trial
    1.To assess the ability of Ga-68-PSMA-11 PET/CT imaging to detect bone metastases in comparison to 99mTc bone scintigraphy
    2.To compare Ga-68-PSMA-11 uptake in primary tumors with Gleason score in surgical specimens from RP.
    3.Determine the percentage of patients in which pre-operative Ga-68-PSMA-11 PET/CT imaging would result into a change in clinical management.
    4.To evaluate the impact of pre-operative Ga-68-PSMA-11 PET/CT imaging on target volume definition for radiotherapy.
    5.Exploratory analysis of molecular and clinical biomarkers (CTC, RNA, DNA, proteins) in blood, serum and plasma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent.
    2.Male ≥ 18 years of age.
    3.Histologically confirmed adenocarcinoma of the prostate.
    4.High risk for metastasis, defined by either:
    a.stadium cT3 according to TNM classification, or
    b.Gleason Score >7, or
    c.PSA >20 ng/mL.
    5.Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7-60 days after start of the study.
    6.Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
    7.Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.
    E.4Principal exclusion criteria
    1.Known hypersensitivity to Ga-68-PSMA-11 or its components.
    2.Presence of known lymph node metastases outside surgical field.
    3.More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
    4.Previous prostate cancer therapy.
    5.Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
    6.Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
    7.Evidence of neuroendocrine small cell carcinoma.
    8.Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
    9. Simultaneous participation in other clinical trials.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the detection of PET signals in prostate gland (on level of quadrant or octant if possible) and lymph nodes of the pelvis (on level of 8 defined subregions) after Ga-68-PSMA-11 injection. Another primary endpoint is occurrence of side effects.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 1
    E.5.2Secondary end point(s)
    Secondary endpoints include detection of bone metastasis, standard uptake values (SUV) of PET signals in prostate gland and lymph nodes of the pelvis, detection of PET signals outside the pelvis, and change of clinical therapy management. Moreover the impact of PSMA imaging on target volume definition in radiotherapy will be studied.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Single arm, rater-blinded
    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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Germany
    Switzerland
    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 is defined as the last visit of the last patient or the last date of follow-up of toxicities, if required (whichever is the later).
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 173
    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)
    This is only a diagnostic study.
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-03
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