Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Radium-223

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   44334   clinical trials with a EudraCT protocol, of which   7366   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    29 result(s) found for: Radium-223. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-004055-20 Sponsor Protocol Number: ICR-CTSU/2013/10040 Start Date*: 2014-09-23
    Sponsor Name:The Royal Marsden NHS Foundation Trust [...]
    1. The Royal Marsden NHS Foundation Trust
    2. The Institute of Cancer Research
    Full Title: A phase II randomised trial of biomarkers to assess (dose-) response in patients with metastatic castration resistant prostate cancer treated with radium-223.
    Medical condition: Castrate resistant prostate cancer with bone metastases.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005993 Bone metastases LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2013-003118-42 Sponsor Protocol Number: BAY88-8223/16507 Start Date*: 2014-08-08
    Sponsor Name:Bayer AG
    Full Title: A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) versus 80 kBq/kg (88 kBq/kg after implementation of NIST update)...
    Medical condition: Castration resistant prostate cancer with bone metastasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SE (Completed) FI (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-003046-17 Sponsor Protocol Number: BAY88-8223/16506 Start Date*: 2013-10-25
    Sponsor Name:Bayer HealthCare AG
    Full Title: A re-treatment safety study of radium-223 dichloride in subjects with castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride ...
    Medical condition: Castration Resistant Prostate cancer patients with bone metastases
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10036916 Prostate cancer stage D LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) NO (Completed) FI (Completed) IT (Completed) ES (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004452-29 Sponsor Protocol Number: IRST185.04 Start Date*: 2017-04-12
    Sponsor Name:ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    Full Title: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC)
    Medical condition: symptomatic bone-only metastatic castration-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10001186 Adenocarcinoma of prostate LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003704-39 Sponsor Protocol Number: BAY88-8223/19781 Start Date*: 2019-10-25
    Sponsor Name:Bayer Consumer Care AG
    Full Title: An open-label, multicenter, Phase 1/2 study of radium-223 dichloride in combination with pembrolizumab in participants with stage IV non-small cell lung cancer
    Medical condition: Stage IV non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) NL (Completed) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-000476-42 Sponsor Protocol Number: 20510 Start Date*: 2020-08-19
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone domi...
    Medical condition: Metastatic castration resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Trial now transitioned) LT (Trial now transitioned) HU (Trial now transitioned) GB (GB - no longer in EU/EEA) FI (Trial now transitioned) AT (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003620-37 Sponsor Protocol Number: STH19580 Start Date*: 2019-10-31
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: NEPTUNE: Enhancement of immuNothEraPy combining avelumab and repeaT doses of radiUm-223 in ER+ve, HER2-ve metastatic breast caNcEr.
    Medical condition: ER+ve HER-ve breast cancer with bone metastases
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10006280 Breast neoplasm benign female LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-000075-16 Sponsor Protocol Number: BAY88-8223/16216 Start Date*: 2012-06-20
    Sponsor Name:Bayer HealthCare AG
    Full Title: Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
    Medical condition: Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10036916 Prostate cancer stage D LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) DE (Completed) NO (Completed) FI (Completed) BE (Completed) ES (Completed) CZ (Completed) IE (Completed) GB (Completed) IT (Completed) DK (Prematurely Ended) NL (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002407-25 Sponsor Protocol Number: 16996 Start Date*: 2014-11-25
    Sponsor Name:Bayer AG
    Full Title: A Phase 4 long-term follow-up study to define the safety profile of radium-223 dichloride
    Medical condition: Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer, breast cancer or multiple myeloma patients with bone metastasis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036916 Prostate cancer stage D LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) ES (Completed) FR (Completed) BE (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001888-36 Sponsor Protocol Number: MedOPP098 Start Date*: 2016-09-27
    Sponsor Name:Medica Scientia Innovation Research (MedSIR ARO)
    Full Title: A phase II clinical trial of radium-223 activity in patients with metastatic castration-resistant prostate cancer (mCRPC) with asymptomatic progression while on abiraterone acetate or enzalutamide ...
    Medical condition: Patients with mCRPC with asymptomatic progression while on abiraterone acetate or enzalutamide
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002184-34 Sponsor Protocol Number: AK-2016-PC-1 Start Date*: 2016-09-14
    Sponsor Name:Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
    Full Title: Phase II trial: uPAR-PET/CT in Radium-223-dichloride treatment of patients with metastatic castration-resistant prostate cancer
    Medical condition: Metastatic castration resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003438-33 Sponsor Protocol Number: BAY88-8223/15396 Start Date*: 2014-04-23
    Sponsor Name:Bayer HealthCare AG
    Full Title: A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildl...
    Medical condition: Asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) ES (Completed) FI (Completed) SE (Completed) DE (Completed) BE (Completed) GB (Completed) NL (Completed) NO (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002113-39 Sponsor Protocol Number: BAY88-8223/16298 Start Date*: 2014-10-29
    Sponsor Name:Bayer AG
    Full Title: A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects ...
    Medical condition: HER2 negative hormone receptor positive metastatic breast cancer with bone metastases treated with standard of care hormonal treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) ES (Completed) AT (Completed) NO (Completed) CZ (Completed) DK (Prematurely Ended) NL (Completed) SE (Completed) PL (Completed) FI (Completed) IE (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002438-58 Sponsor Protocol Number: BAY88-8223/18987 Start Date*: 2016-11-16
    Sponsor Name:Bayer AG
    Full Title: A phase 1b/2 trial to evaluate the safety and efficacy of radium-223 dichloride (BAY 88-8223) in combination with bortezomib and dexamethasone in early relapsed multiple myeloma
    Medical condition: Relapsed multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-002944-10 Sponsor Protocol Number: c16174 Start Date*: 2019-02-27
    Sponsor Name:Memorial Sloan Kettering Cancer Center
    Full Title: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    Medical condition: Patients with histological or cytological proof of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002114-23 Sponsor Protocol Number: BAY88-8223/17096 Start Date*: 2015-10-26
    Sponsor Name:Bayer HealthCare AG
    Full Title: A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with exemestane and everolimus versus placebo in combination with exemestane and everolimus whe...
    Medical condition: Metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) GB (Completed) ES (Completed) AT (Completed) CZ (Completed) NL (Completed) DE (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002833-70 Sponsor Protocol Number: s56892 Start Date*: 2014-12-18
    Sponsor Name:UZLeuven
    Full Title: Radium-223 in patients with PSA progression and without clinical metastases following maximal local therapy: a pilot study
    Medical condition: Patients with prostate cancer (PCa) who experience PSA progression and who are without detectable metastases following maximal local treatment consisting of radical prostatectomy (RP) + pelvic l...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004850-97 Sponsor Protocol Number: 13-21 Start Date*: 2014-07-11
    Sponsor Name:Cancer Trials Ireland
    Full Title: A Phase II Study of Radium-223 in Combination with Enzalutamide in Progressive Metastatic Castrate-Resistant Prostate Cancer
    Medical condition: Metastatic castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000299-15 Sponsor Protocol Number: BC1-03 Start Date*: 2004-11-03
    Sponsor Name:Algeta AS
    Full Title: A double-blind, dose-response, phase II, multicentre study of radium-223 (Alpharadin TM ) for the palliation of painful bone metastases in hormone refractory prostate cancer patients
    Medical condition: The target population is patients suffering from bone pain due to skeletal metastasis secondary to prostate cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-012189-30 Sponsor Protocol Number: BC1-09 Start Date*: 2009-10-30
    Sponsor Name:Algeta ASA
    Full Title: An open-label Phase IIa, non-randomised, study of Alpharadin in breast cancer patients with bone dominant disease who are no longer considered suitable for endocrine therapy
    Medical condition: Breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for further endocrine therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027452 Metastases to bone LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 01 15:33:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA