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 States1,472 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 range18 Years

SexMALE

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

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

Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression

Timeframe: From last Radium-223 dose up to 6 months post 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 range18 Years

SexMALE

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

Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression

Timeframe: From last Radium-223 dose up to 6 months post last dose of Radium-223