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Radium-223 safety checked in over 1,400 prostate cancer patients

NCT ID NCT02141438

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed over 1,400 men with metastatic castration-resistant prostate cancer who were already receiving Radium-223 as part of their routine care. Researchers tracked serious side effects and the development of new cancers over several years. The goal was to better understand the long-term safety of this treatment in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radium-223 (Xofigo)
What this could lead to
If successful, this study could confirm the long-term safety of Radium-223 and help doctors better understand the risk of second cancers in men with advanced prostate cancer.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by other treatments patients received.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,472 people

The number who actually took part.

Started

Aug 2014

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases for whom the treatment decision to Radium-223 has been made independent from and before patient enrolment in the study.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study * Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases * Signed informed consent Exclusion Criteria: * Previously treated with Radium-223 for any reason * Currently treated in clinical trials including other Radium-223 studies * Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

  • Study site

    Anchorage, Alaska, United States

  • Study site

    Scottsdale, Arizona, United States

  • Study site

    Daly City, California, United States

  • Study site

    Long Beach, California, United States

  • Study site

    Sacramento, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    Colorado Springs, Colorado, United States

  • Study site

    Boca Raton, Florida, United States

  • Study site

    Fort Myers, Florida, United States

  • Study site

    Jacksonville, Florida, United States

  • Study site

    Lakewood Rch, Florida, United States

  • Study site

    Plantation, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Decatur, Georgia, United States

  • Study site

    Honolulu, Hawaii, United States

  • Study site

    Evanston, Illinois, United States

  • Study site

    Warrenville, Illinois, United States

  • Study site

    Wichita, Kansas, United States

  • Study site

    Ashland, Kentucky, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Rockville, Maryland, United States

  • Study site

    Towson, Maryland, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Troy, Michigan, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Billings, Montana, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Lebanon, New Hampshire, United States

  • Study site

    Neptune City, New Jersey, United States

  • Study site

    Township, New Jersey, United States

  • Study site

    Buffalo, New York, United States

  • Study site

    East Setauket, New York, United States

  • Study site

    Lake Success, New York, United States

  • Study site

    Winston-Salem, North Carolina, United States

  • Study site

    Middleburg Heights, Ohio, United States

  • Study site

    Oklahoma City, Oklahoma, United States

  • Study site

    Springfield, Oregon, United States

  • Study site

    Abington, Pennsylvania, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Myrtle Beach, South Carolina, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Lubbock, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Temple, Texas, United States

  • Study site

    Charlottesville, Virginia, United States

  • Study site

    Virginia Beach, Virginia, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Multiple Locations, Argentina

  • Study site

    Multiple Locations, Austria

  • Study site

    Multiple Locations, Belgium

  • Study site

    Multiple Locations, Canada

  • Study site

    Multiple Locations, Colombia

  • Study site

    Multiple Locations, Czechia

  • Study site

    Multiple Locations, Denmark

  • Study site

    Multiple Locations, France

  • Study site

    Multiple Locations, Germany

  • Study site

    Multiple Locations, Greece

  • Study site

    Multiple Locations, Israel

  • Study site

    Multiple Locations, Italy

  • Study site

    Multiple Locations, Luxembourg

  • Study site

    Multiple Locations, Mexico

  • Study site

    Multiple Locations, Netherlands

  • Study site

    Multiple Locations, Portugal

  • Study site

    Multiple Locations, Spain

  • Study site

    Multiple Locations, Sweden

  • Study site

    Multiple Locations, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.