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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506435-15-00 | Registry Identifier | CTIS(EU) | |
| 2019-000475-17 | EudraCT Number |
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In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Low extent of disease | Experimental | Adult men with bone mCRPC having < 6 bone metastases |
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| Patients with High extent of disease | Experimental | Adult men with bone mCRPC having ≥ 6 bone metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Drug will be administered as aqueous solution intravenously at a dose of 55 kBq/kg body weight every 4 weeks for 6 cycles (cycle length = 4 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of radium-223 in tumor-free bone after 3 doses | The uptake of radium-223 in bone is determined with single-photon emission tomography / computed tomography (SPECT/CT). | At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of radium-223 in tumor-free bone after single dose | At 4, 24 and 144 hours post injection at Cycle 1 ( total duration of one cycle is 28 days). | |
| AUC of radium-223 in tumor-free bone after 6 doses | At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinikum Salzburg - Landeskrankenhaus | Salzburg | 5020 | Austria | |||
| ICM - Institut du Cancer de Montpellier - Val d'Aurelle |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Montpellier |
| 34298 |
| France |
| HCL - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Institut de Cancerologie Ouest - Saint-Herblain | Saint-Herblain | 44800 | France |
| Institut Claudius Regaud - iUCT Oncopole | Toulouse | 31059 | France |
| Rambam Health Corporation | Haifa | 3109601 | Israel |
| Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale | Reggio Emilia | Emilia-Romagna | 42123 | Italy |
| National Cancer Institute | Vilnius | LT-08660 | Lithuania |
| Vilnius University Hospital Santaros Klinikos | Vilnius | LT-08661 | Lithuania |
| Royal Marsden NHS Trust (Surrey) | Sutton | Surrey | SM2 5PT | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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