do_not_disturb_altRecruitment Complete

Bone metastatic castration-resistant prostate cancer

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

Male

Age

18 - N/A

Trial summary

Enrollment Goal
46
Trial Dates
November 2020 - September 2025
Phase
Phase 1
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Universitätsklinikum Münster (UKM)Münster, 48149, Germany
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Institut Claudius Regaud - iUCT OncopoleTOULOUSE CEDEX 9, 31059, France
Withdrawn
Gustave Roussy - Departement Oncologie-RadiotherapieVILLEJUIF CEDEX, 94805, France
Completed
HCL - Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Completed
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia ProvincialeReggio Emilia, 42123, Italy
Withdrawn
Ordensklinikum Linz GmbH ElisabethinenLinz, 4020, Austria
Completed
Uniklinikum Salzburg - LandeskrankenhausSalzburg, 5020, Austria
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Guy's and St. Thomas' NHS Trust, St. Thomas' HospitalLondon, SE1 7EH, United Kingdom
Completed
University College London Hospitals NHS Foundation TrustLondon, NW1 2PG, United Kingdom
Withdrawn
HUS, Meilahden sairaalaHelsinki, 00290, Finland
Completed
ICM - Institut du Cancer de Montpellier - Val d'AurelleMONTPELLIER CEDEX, 34298, France
Completed
Institut de Cancerologie Ouest - Saint-HerblainSaint-Herblain, 44800, France
Completed
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
National Cancer InstituteVilnius, LT-08660, Lithuania

Primary Outcome

  • 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).
    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 dose
    date_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 doses
    date_rangeTime Frame:
    At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).

Trial design

Open-label, non-randomized Phase 1, multicenter study to assess radium-223 biodistribution in participants with bone metastatic castration resistant prostate cancer (CRPC) receiving radium-223 dichloride treatment.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2