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Bone Metastatic Castration-resistant Prostate CancerPhase 1NCT04521361

A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

A Phase 1 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Bone Metastatic Castration-resistant Prostate Cancer, run by Bayer at 12 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Radium-223 dichloride (Xofigo, BAY88-8223)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
12 sitesin 6 countries
Study dates
16 Nov 2020to 27 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who have histologically confirmed adenocarcinoma of the prostate.
  • Participants with bone metastatic CRPC, progressing after 1 or 2 prior lines of systemic treatment for metastatic prostate cancer (including prior treatment for metastatic hormone sensitive prostate mHSPC or metastatic castration resistant prostate cancer mCRPC).
  • Participants with at least 2 bone metastases on Tc 99m phosphonate whole body planar bone scans at Screening.
  • Documented progression of mCRPC. Disease progression is defined by at least one of the following criteria: a. PCWG3 criteria (defined as 2 consecutive increases in PSA over a previous reference value measured at least one week prior, with a minimal start value of 1.0 ng/mL) or b. ≥2 new bone lesions (according to PCWG3 bone scan criteria) or c. Radiological progression according to RECIST, version 1.1.
  • Ability to participate in the required study procedures including all scanning procedures and ability to control pain to ensure tolerance and completion of the necessary scanning procedures.
  • Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to start of Screening and must be continued throughout the study.
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  • Participants must be on a bone health agent prior to the first dose of radium-223 dichloride. Participants with at least 6 months of prior bone health agent (BHA) treatment are preferred.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  • Life expectancy ≥6 months.

Who cannot join

  • Any chronic medical condition requiring continuous systemic corticosteroid treatment at a higher dose than 5 mg prednisone / prednisolone twice daily.
  • Pathological finding consistent with neuroendocrine features small cell carcinoma of the prostate.
  • Metastatic bone deposits extend of disease (EOD) grades 0 or 4 (according to centrally assessed Tc 99m phosphonate planar bone scans during Screening).
  • History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations (according to central review at screening).
  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
  • Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). - Participants with history of spinal cord compression should have completely recovered.
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  • Active or symptomatic viral hepatitis
  • Inability to tolerate any of the other imaging procedures in the study (ie, bone SPECT/CT and planar bone scans with a Tc 99m phosphonate radiotracer, DXA scan, radium-223 SPECT/CT scans).
  • Any condition, which in the opinion of the investigator would preclude participation in this trial.
  • Hypersensitivity to radium-223 dichloride.
  • Blood transfusion or erythropoietin stimulating agents 4 weeks prior to start of Screening and during the whole Screening period before enrollment into the cohort.
  • Prior administration of an investigational therapeutic for CRPC.

Trial locations and contacts

12 sites in 6 countries.

12 sites in 6 countries

France4 sites

  • ICM - Institut du Cancer de Montpellier - Val d'Aurelle

    Montpellier, 34298

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, 44800

  • Institut Claudius Regaud - iUCT Oncopole

    Toulouse, 31059

Other trials in France

United Kingdom3 sites

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital

    London, SE1 7EH

  • Royal Marsden NHS Trust (Surrey)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Lithuania2 sites

  • National Cancer Institute

    Vilnius, LT-08660

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Austria1 site

  • Uniklinikum Salzburg - Landeskrankenhaus

    Salzburg, 5020

Other trials in Austria

Israel1 site

  • Rambam Health Corporation

    Haifa, 3109601

Other trials in Israel

Italy1 site

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

    Reggio Emilia, Emilia-Romagna, 42123

Other trials in Italy

About this study

Official 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.

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).

Being tested
Radium-223 dichloride (Xofigo, BAY88-8223)
Keywords
Metastatic castration-resistant prostate cancer (mCRPC), Single-photon emission tomography / computed tomography (SPECT/CT), radium-223,, phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT04521361
Study groupRoleWhat they receive
Patients with Low extent of diseaseExperimentalAdult men with bone mCRPC having < 6 bone metastases
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Patients with High extent of diseaseExperimentalAdult men with bone mCRPC having ≥ 6 bone metastases
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).

Secondary outcomes (2)

  1. AUC of radium-223 in tumor-free bone after single dose

    Measured: At 4, 24 and 144 hours post injection at Cycle 1 ( total duration of one cycle is 28 days).

  2. AUC of radium-223 in tumor-free bone after 6 doses

    Measured: At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start16 Nov 2020
  3. Primary completion10 Oct 2023
  4. Study completion27 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521361
Sponsor's protocol ID
20511
Other IDs
2023-506435-15-00, 2019-000475-17, 2019, 2023
Status last verified
Sep 2025
First submitted
3 Aug 2020
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Bone Metastatic Castration-resistant Prostate Cancer, run by Bayer at 12 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, United Kingdom, Lithuania, Austria, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC of radium-223 in tumor-free bone after 3 doses (time frame: At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04521361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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