CompletedNot Applicable

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

United States, Argentina, Austria1,472 participantsStarted 2014-08-20

Plain-language summary

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Second Primary Malignancies (SPM)

Timeframe: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Number of Participants With Drug-related Treatment-emergent Adverse Events

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Number of Participants With Drug-related SAEs

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223

Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223

Trial details

NCT IDNCT02141438

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-02

Results submitted2025-07-17

View on ClinicalTrials.gov More Metastatic Castration-resistant Prostate Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Second Primary Malignancies (SPM)

Timeframe: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Number of Participants With Drug-related Treatment-emergent Adverse Events

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223

Number of Participants With Drug-related SAEs

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223

Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression

Timeframe: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223