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Clinical trials for PI-RADS

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    6 result(s) found for: PI-RADS. Displaying page 1 of 1.
    EudraCT Number: 2016-002504-43 Sponsor Protocol Number: LPC-004 Start Date*: 2016-12-30
    Sponsor Name:LIDDS AB
    Full Title: A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Ass...
    Medical condition: Asymptomatic localized prostate cancer patients
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002571-11 Sponsor Protocol Number: ENHANCE Start Date*: 2022-11-25
    Sponsor Name:Institut Mutualiste Montsouris
    Full Title: EvaluatioN of High-Intensity Focused Ultrasound (HIFU) Hemi-ablation and short-term AndrogeN deprivation therapy Combination to Enhance prostate control for intermediate risk localized prostate can...
    Medical condition: Intermediate risk localized prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10036946 Prostatic cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002854-19 Sponsor Protocol Number: S58827 Start Date*: 2017-08-03
    Sponsor Name:UZ Leuven
    Full Title: Neoadjuvant degarelix +/- apalutamide (ARN-509) followed by radical prostatectomy for intermediate and high-risk prostate cancer: a randomized, placebo-controlled trial.
    Medical condition: Prostate cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005042-42 Sponsor Protocol Number: CURF18PSM0001 Start Date*: 2021-06-27
    Sponsor Name:CURIUM Austria GmbH
    Full Title: Prospective study of added value of florastamin (18F) PET/CT in localisation of clinically significant prostate cancer in patients with PI-RADS≤3 report of multi-parametric MRI, elevated serum PSA ...
    Medical condition: Prostate cancer suspected clinically and on the basis of elevated serum Prostate Specific Antigen (PSA) levels and PSA density and with result of multiparametric Magnetic Resonance Imaging (mpMRI) ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    20.0 10022891 - Investigations 10053838 Free prostate-specific antigen increased PT
    20.1 10022891 - Investigations 10050321 Prostate examination PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029096 Neoplasm prostate PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004385 Benign neoplasm of prostate PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004694-41 Sponsor Protocol Number: PRX302-2-08 Start Date*: 2017-02-03
    Sponsor Name:Sophiris Bio Corp. 1258 Prospect Street La Jolla, CA 92037 USA
    Full Title: A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy of Targeted Intraprostatic Administration of PRX302 to Treat Men with Histologically Proven, Clinically...
    Medical condition: Prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004872 10036966 Prostatic neoplasms and hypertrophy HLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004685-18 Sponsor Protocol Number: PSMA-PROSTAPET Start Date*: 2020-07-28
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Evaluation of diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in primary staging of Intermediate and High Risk Prostatic Cancer in men newly diagnosed
    Medical condition: Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10036927 Prostate neoplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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