Radium-223 biodistribution study in patients with bone metastatic CRPC

  • Research type

    Research Study

  • Full title

    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.

  • IRAS ID

    280504

  • Contact name

    Chistopher Parker

  • Contact email

    chris.parker@icr.ac.uk

  • Sponsor organisation

    Bayer Consumer Care, AG

  • Eudract number

    2019-000475-17

  • Duration of Study in the UK

    4 years, 11 months, days

  • Research summary

    This study will evaluate how radium-223 dichloride (marketed as Xofigo) is spread around the body, particularly into the bone and bone metastases of the underlying disease in patients with metastatic castration resistant prostate cancer (mCRPC). Radium-223 dichloride will be given as an infusion (approximately 1 minute) to participants every 28 days (4 weeks) for a total of up to 6 administrations. Each patient will be prescribed the same dose, the actual volume of study drug administered will be calculated using patient’s body weight in kg. About 60 patients will take part in the study in approximately 5 countries. Patients will visit the study site approximately 23 times; the expected study duration is 9 months (1 month to check suitability for the study, 6 months on active treatment and 2 months for follow up after final treatment). There will be two groups of patients recruited into the study; the allocation of patients to each group is dependent on the quantity of their disease that spreads to the bones (low and high number of bone metastases). 30 patients will be enrolled per cohort. Patients in both groups will receive the same treatment and will have the same procedures. Participants will undergo a physical examination, have vital signs and height/weight measured and have blood samples taken. Patients will also receive regular ECGs and various scans over the course of the study to measure the spread of the study drug; participants will undergo bone SPECT/CT, Radium SPECT / CT, MRI and DXA scans.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    20/SC/0218

  • Date of REC Opinion

    29 Jul 2020

  • REC opinion

    Further Information Favourable Opinion