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    The EU Clinical Trials Register currently displays   43202   clinical trials with a EudraCT protocol, of which   7150   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004425-13
    Sponsor's Protocol Code Number:PP01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-004425-13
    A.3Full title of the trial
    Prospective evaluation of 68-Ga-PSMA-PET and early PSA kinetics during salvage radiotherapy for personalizing the management of men with relapse of prostate cancer after radical prostatectomy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective evaluation of 68-Ga-PSMA-PET and early PSA kinetics during salvage radiotherapy for personalizing the management of men with relapse of prostate cancer after radical prostatectomy.
    En prospektiv studie för att utvärdera undersökning med 68-Ga-PSMA-PET under strålbehandling för att individanpassa behandlingen hos patienter med prostatacancer efter radikal prostataresektion.
    A.3.2Name or abbreviated title of the trial where available
    PROPER
    PROPER
    A.4.1Sponsor's protocol code numberPP01
    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 SponsorSkåne University Hospital, Department of Oncology
    B.1.3.4CountrySweden
    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 supportSkåne University Hospital, Department of Oncology
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital
    B.5.2Functional name of contact pointDepartment of Oncology
    B.5.3 Address:
    B.5.3.1Street AddressGetingevägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+464617 75 20
    B.5.5Fax number+464617 60 23
    B.5.6E-mailadalsteinn.gunnlaugson@skane.se
    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 name68-Ga-PSMA
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code68GA-PSMA
    D.3.9.3Other descriptive name68GA-PSMA HBED-CC
    D.3.9.4EV Substance CodeSUB171041
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Patients with prostate cancer, with a PSA recurrence of ˃
    0.2 ng/ml after prostatectomy, and who are going to receive radiotherapy to the prostate bed.
    Patienter med prostatacancer, vilka återfallit i sin sjukdom definierat som en förhöjning av PSA-värdet med 0.2 ng/ml efter resektion av prostata, och som skall erhålla strålbehandling mot prostatabädden.
    E.1.1.1Medical condition in easily understood language
    Patients with prostate cancer, with a PSA recurrence of ˃
    0.2 ng/ml after prostatectomy, and who are going to receive radiotherapy to the prostate bed.
    Patienter med prostatacancer, vilka återfallit i sin sjukdom definierat som en förhöjning av PSA-värdet med 0.2 ng/ml efter resektion av prostata, och som skall ha strålbehandling mot prostatabädden.
    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 10066489
    E.1.2Term Progression of prostate cancer
    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
    The ability of 68-Ga-PSMA-PET to identify relapse of prostate cancer in patients with recurrence after prostatectomy.
    Möjligheten att med hjälp av 68-Ga-PSMA-PET identifiera återfallslokal av prostatacancer hos patienter som erhåller strålbehandling för återfall av cancer efter radikal prostatektomi.
    E.2.2Secondary objectives of the trial
    - PSA response (during treatment)
    - PSA response (at 3, 6, 9, 12, and 24 months post treatment
    - Overall survival
    - Toxicity
    - Quality of life
    - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting
    - Prevalence of distant metastases (68-Ga-PSMA-PET/m-MRT) in the salvage setting
    - Prevalence of local recurrent disease (68-Ga-PSMA-PET) in the salvage setting
    - Time to hormone therapy/chemotherapy
    - PSA respons
    - PSA respons (vid 3, 6, 9, 12, och24 månader efter avslutad behandling
    - Totalöverlevnad
    - Toxicitet
    - Livskvalitet
    - Prevalens av lymfkörtelmetastasering (utvärderat med 68-Ga-PSMA-PET)
    - Prevalens av fjärrmetastasering ( utvärderat med 68-Ga-PSMA-PET/m-MRT)
    - Prevalens lokalt återfall ( utvärderat med 68-Ga-PSMA-PET)
    - Tid till start av hormonell behandling eller cytostatikabehandling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed prostate cancer
    - PSA recurrence after prostatectomy (defined as a PSA ˃ 0.2 ng/ml confirmed in a second sample)
    - Expected Life-expectancy of ˃ 10 years
    - Any pT, pN0/X, M0/X
    - Patients suitable for radiotherapy
    - Konfirmerad prostatacancer
    - Återfall i prostatacancer (definierat som en förhöjning av PSA med ˃ 0.2 ng/ml, konfirmerat med ett andra blodprov)
    - Förväntad överlevnad ˃ 10 år
    - Alla T, N0/X, M0/X
    - Patient lämplig för att erhålla strålbehandling
    E.4Principal exclusion criteria
    - Previous malignancy other than basalioma within the last 5 years
    - Previous or ongoing hormonal therapy
    - Inability to sign written informed concent
    - Tidigare malignitet förutom basaliom inom de senaste 5 åren
    - Tidigare eller pågående hormonell behandling
    - Inkapabel att signera informerat samtycke
    E.5 End points
    E.5.1Primary end point(s)
    The ability of 68-Ga-PSMA-PET to identify prostate cancer recurrence in patients with biochemical relapse after prostatectomy.
    Att med hjälp av 68-Ga-PSMA-PET identifiera prostata cancer recidivlokaler hos patienter med återfall efter prostatektomi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 5 weeks of radiotherapy.
    Efter 5 veckors strålbehandling.
    E.5.2Secondary end point(s)
    - PSA response (during treatment)
    - PSA response (at 3, 6, 9, 12, and 24 months post-treatment)
    - Overall survival
    - Toxicity
    - Quality of Life
    - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting
    - Prevalence of distant metastases (68-Ga-PSMA-PET) in the salvage setting
    - Prevalence of local recurrent disease (68-Ga-PSMA-PET/m-MRT) in the salvage setting
    - Time to hormone therapy/chemotherapy
    - PSA respons (under behandling)
    - PSA respons (vid 3, 6, 9, 12 och 24 månader efter behandling)
    - Totalöverlevnad
    - Toxicitet
    - Livskvalitet
    - Förekomst av lymfkörtelmetastasering (68-Ga-PSMA-PET) under den understödjande behandlingen
    - Förekomst av fjärrmetastaser (68-Ga-PSMA-PET) under den understödjande behandlingen
    - Förekomst av lokalrecidiv (68-Ga-PSMA-PET/m-MRT under den understödjande behandlingen
    - Tid till hormonell behandling/cytostatikabehandling
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PSA evaluation weekly during radiotherapy
    - Evaluation with 68-Ga-PSMA-PET after 5 weeks of radiotherapy
    - PSA evaluation at 3, 6, 9, 12 months after end of radiotherapy, thereafter every 6 months until progressive disease.
    - Evaluation of quality of life before start of treatment, at end of radiotherapy, and at 1 year after end of radiotherapy
    - Utvärdering av PSA 1 gång per vecka under strålbehandlingen
    - Utvärdering med 68-Ga-PSMA efter 5 veckors strålbehandling
    - Utvärdering av PSA vid 3, 6, 9 och 12 månader efter avslutad strålbehandling, därefter var sjätte månad fram till progressiv sjukdom
    - Utvärdering av livskvalitet före start av behandling, vid avslut av behandling samt 1 år efter avslutad strålbehandling
    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 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) 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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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
    LVLS.
    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 months6
    E.8.9.1In the Member State concerned 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 3 and 12 months after end of treatment: Physical examination, WHO performance status, PSA, HB- and blood chemistry, register adverse events and toxicity (CTCAE v. 4.0 - urinary, intestinal, sexual.


    Every 6th month after end of radiotherapy: Assessment of of PSA until further systemic intervention or death.

    Date of progressive disease (defined as a rise of 0.2 ng/ml in PSA from nadir, date of start of hormonal therapy or chemotherapy and date of death will be registered.
    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 Decision2016-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-20
    P. End of Trial
    P.End of Trial StatusOngoing
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