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    Summary
    EudraCT Number:2020-004235-24
    Sponsor's Protocol Code Number:ABX-CT-303
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004235-24
    A.3Full title of the trial
    Phase III study of [18F]PSMA-1007 positron emission tomography for the detection of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detection of Prostate Cancer Lesions with Imaging Tracer for Positron Emission Tomography in Patients who have previously been treated for Prostate Cancer
    A.4.1Sponsor's protocol code numberABX-CT-303
    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 SponsorABX GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportABX GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationpharmtrace klinische Entwicklung GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressWolframstraße 93-94
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12105
    B.5.3.4CountryGermany
    B.5.4Telephone number+493063222700
    B.5.5Fax number+4930632227099
    B.5.6E-mailabx-ct-303@pharmtrace.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 nameF-18-PSMA-1007
    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 INNF-18-PSMA-1007
    D.3.9.2Current sponsor codeF-18-PSMA-1007
    D.3.9.3Other descriptive nameF-18-PSMA-1007
    D.3.9.4EV Substance CodeSUB194628
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 40
    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
    Suspicion of prostate cancer recurrence or persistence after previous definitive treatment, based on American Society for Radiation Oncology (ASTRO) criteria of 3 consecutive PSA rises and/or ASTRO/Phoenix criteria of PSA nadir above 2.0 ng/mL after radiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy
    E.1.1.1Medical condition in easily understood language
    Patients with prostate cancer in whom the treating physician suspect recurrence. All patients in this trial have received an effective and successful initial treatment the after diagnosis
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    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
    To assess, in an independent assessment by 3 blinded readers:

    1. the Region-level positive predictive value (PPV) defined as the percentage of all PET-positive regions containing at least one true positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET imaging and the reference standard), regardless of any co-existent false positive findings within the same region, out of all regions containing at least one [18F]PSMA-1007 PET- positive finding. Regions to be considered in the analysis are prostate bed, pelvic lymph nodes, skeleton, and other distant sites (extrapelvic lymph nodes and viscera).
    2. the Patient-level “correct detection rate” defined as the percentage of patients who have at least one true PET-positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET imaging and the reference standard), regardless of any co-existent false positive findings, out of all patients who are scanned.
    E.2.2Secondary objectives of the trial
    1. to assess the correct detection rate and PPV of the clinical investigator for [18F]PSMA-1007 for metastatic prostate cancer lesions (patient-based analysis)
    2. to assess detection rate and PPV of [18F]PSMA-1007 by body region for prostate cancer lesions (region-based analysis: prostate bed, pelvic lymph nodes, skeleton, and other distant sites [extrapelvic lymph nodes and viscera]). reads by investigator and 3 independent blinded readers)
    3. to assess the safety profile of [18F]PSMA-1007
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
    2. Suspicion of recurrence or persistence
    -- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
    -- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
    3. For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
    4. Life expectancy of 6 months or more as judged by the investigator
    5. Willing and able to undergo all study procedures
    6. Informed consent in writing (dated and signed)
    E.4Principal exclusion criteria
    1. Age: less than18 years
    2. Contraindications to any of the ingredients of [18F]PSMA-1007
    3. Close affiliation with the investigational site; e.g. first-degree relative of the investigator
    4. At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
    5. Having been previously enrolled in this clinical trial
    6. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
    7. Being clinically unstable or requiring emergency treatment
    8. Patients who are unwilling to consider a biopsy if clinically recommended
    9. Patients who are unable to undergo a PET/CT scan (e.g,, patients who are extremely obese, unable to lie flat or remain still, or have uncontrollable claustrophobia)
    10. Patients for whom systemic therapy is the most likely course regardless of PET findings.
    E.5 End points
    E.5.1Primary end point(s)
    recurrence rate detected
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial, after completion of 6-months clinical follow-up in all patients who complete the study
    E.5.2Secondary end point(s)
    1. detection rate of prostate cancer lesions (patient-based: local investigator) 2. per body region: sensitivity and specificity for detection of prostate cancer lesions (local investigators and independent read; expert panel assessment as standard of truth) 3. diagnostic thinking and therapeutic decisions (local investigators and expert panel) 4. appropriateness of therapeutic decisions (expert panel) 5. adverse events / safety 6. Dosimetry estamtes for F-18-PSMA-1007
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial, after completion of 6-months clinical follow-up in all patients who complete the study
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard of Truth: assessment by an expert panel using collected information during follow up
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 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
    Netherlands
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 70
    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)
    None
    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 Decision2020-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-23
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