do_not_disturb_altRecruitment Complete
Bone metastatic castration-resistant prostate cancer
Bayer Identifier:
20511
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to assess how radium-223 distributes in the body of patients with prostate cancer which spread to the bones
Trial purpose
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).
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
46Trial Dates
November 2020 - August 2025Phase
Phase 1Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Universitätsklinikum Münster (UKM) | Münster, 48149, Germany |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Institut Claudius Regaud - iUCT Oncopole | TOULOUSE CEDEX 9, 31059, France |
Withdrawn | Gustave Roussy - Departement Oncologie-Radiotherapie | VILLEJUIF CEDEX, 94805, France |
Completed | HCL - Centre Hospitalier Lyon Sud | PIERRE BENITE, 69495, France |
Completed | Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale | Reggio Emilia, 42123, Italy |
Withdrawn | Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria |
Completed | Uniklinikum Salzburg - Landeskrankenhaus | Salzburg, 5020, Austria |
Active, not recruiting | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Active, not recruiting | Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital | London, SE1 7EH, United Kingdom |
Active, not recruiting | University College London Hospitals NHS Foundation Trust | London, NW1 2PG, United Kingdom |
Withdrawn | HUS, Meilahden sairaala | Helsinki, 00290, Finland |
Active, not recruiting | Institut du Cancer de Montpellier - Val d'Aurelle | MONTPELLIER CEDEX, 34298, France |
Completed | Institut de Cancérologie de l'Ouest - Saint Herblain | Saint-Herblain, 44800, France |
Completed | Vilnius University Hospital Santaros Klinikos | Vilnius, LT-08661, Lithuania |
Active, not recruiting | National Cancer Institute | Vilnius, LT-08660, Lithuania |
Primary Outcome
- AUC of radium-223 in tumor-free bone after 3 dosesThe uptake of radium-223 in bone is determined with single-photon emission tomography / computed tomography (SPECT/CT).date_rangeTime Frame:At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).
Secondary Outcome
- AUC of radium-223 in tumor-free bone after single dosedate_rangeTime Frame: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 dosesdate_rangeTime Frame:At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2