An observational study in Metastatic Castration-resistant Prostate Cancer, sponsored by Bayer. Completed at 68 sites in 20 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Bayer · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 1,472 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.
Number of Participants With Second Primary Malignancies (SPM)
Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician
Time frame: 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)
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
Time frame: 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
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
Time frame: 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
All drug-related SAEs were collected up to 7 years after the last administration of radium-223.
Time frame: 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
Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)
Time frame: 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
Hematological toxicities were summarized by the Common Terminology Criteria for Adverse Events (CTCAE) coding system and the worst grade. The grading system ranges from Grade 1 (mild) to Grade 5 (death). The percentage of participants with post-radium-223 treatment CTCAE grade 3 or 4 hematological toxicities that occurred within 183 days from last radium-223 injection are reported
Time frame: From last Radium-223 dose up to 6 months post last dose of Radium-223
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC)
Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223
Time frame: From 30 days after last dose of Radium-223 up to 6 months after last dose
Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage
Participants who receive subsequent cytotoxic chemotherapy were followed for the development of febrile neutropenia and hemorrhage up to 6 months after the last administration of chemotherapy at a frequency based on local clinical practice.
Time frame: From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy
Overall Survival
Overall survival was defined as the time interval from the start of Radium-223 therapy to death due to any cause. Patients whose death was not confirmed at the time of data-cut were censored at the last date known to be alive.
Time frame: 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
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain severity on a scale from 0 (no pain) to 10 (worst pain). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain severity score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary. Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
Time frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain interference on a scale from 0 (does not interfere) to 10 (completely interferes). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain interference score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
Time frame: From initiation of Radium-223 (treatment period up to 6 months which includes 4 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
Percentage of Participants With Bone Fractures
Bone fractures were identified by MedDRA HLGTs: Fractures: HLGT = "Fractures".
Time frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223
Percentage of Participants With Bone Associated Events
Bone associated events were identified by MedDRA HLGTs: Bone associated events: HLGT = "Bone disorders (excl congenital and fractures)"
Time frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223
The study was conducted at 188 treatment centers in 20 countries from 20 August 2014 (first patient first visit) to 02 August 2024 (last patient last visit)
| Milestone | Radium-223 |
|---|---|
| Started | 1472 |
| Completed | 22 |
| Not completed | 1450 |
| Withdrew: Death | 1308 |
| Withdrew: Lost to follow-up | 84 |
| Withdrew: Withdrawal by subject | 52 |
| Withdrew: Physician decision | 1 |
| Withdrew: Patients without documented end of observation due to premature site closure | 5 |
Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician
| Participants | Radium-223 |
|---|---|
| Number of Participants With Second Primary Malignancies (SPM) | 24 |
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
| Participants | Radium-223 |
|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 325 |
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
| Participants | Radium-223 |
|---|---|
| Number of Participants With Drug-related Treatment-emergent Adverse Events | 537 |
All drug-related SAEs were collected up to 7 years after the last administration of radium-223.
| Participants | Radium-223 |
|---|---|
| Number of Participants With Drug-related SAEs | 88 |
Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)
| Participants | Radium-223 |
|---|---|
| Patients with at least one of the bone marrow suppression relevant treatments — No | 1133 |
| Patients with at least one of the bone marrow suppression relevant treatments — Yes | 339 |
| Patients with any blood transfusions — No | 1155 |
| Patients with any blood transfusions — Yes | 317 |
| Patients receiving erythropoiesis stimulating drugs — No | 1448 |
| Patients receiving erythropoiesis stimulating drugs — Yes | 24 |
| Patients with colony stimulating factors — No | 1448 |
| Patients with colony stimulating factors — Yes | 24 |
Overall survival was defined as the time interval from the start of Radium-223 therapy to death due to any cause. Patients whose death was not confirmed at the time of data-cut were censored at the last date known to be alive.
| Months | Radium-223 |
|---|---|
| Overall Survival | 15.6 (14.6 to 16.4) |
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain severity on a scale from 0 (no pain) to 10 (worst pain). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain severity score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary. Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
| Score | Radium-223 |
|---|---|
| Baseline/Treatment cycle 1 | 3.003 ± 2.189 |
| Treatment cycle 2 (approximately at week 4) | 2.760 ± 2.251 |
| Treatment cycle 3 (approximately at week 8) | 2.464 ± 2.222 |
| Treatment cycle 4 (approximately at week 12) | 2.436 ± 2.309 |
| Treatment cycle 5 (approximately at week 16) | 2.261 ± 2.223 |
| Treatment cycle 6 (approximately at week 20) | 2.262 ± 2.210 |
| First available follow-up measurement | 2.458 ± 2.307 |
| Last available follow-up measurement | 2.629 ± 2.424 |
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain interference on a scale from 0 (does not interfere) to 10 (completely interferes). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain interference score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
| Score | Radium-223 |
|---|---|
| Baseline/Treatment 1 | 3.283 ± 2.664 |
| Treatment cycle 2 (approximately at week 4) | 2.965 ± 2.588 |
| Treatment cycle 3 (approximately at week 8) | 2.656 ± 2.469 |
| Treatment cycle 4 (approximately at week 12) | 2.587 ± 2.525 |
| Treatment cycle 5 (approximately at week 16) | 2.358 ± 2.408 |
| Treatment cycle 6 (approximately at week 20) | 2.495 ± 2.425 |
| First available follow-up measurement | 2.809 ± 2.570 |
| Last available follow-up measurement | 3.107 ± 2.774 |
Bone fractures were identified by MedDRA HLGTs: Fractures: HLGT = "Fractures".
| Percentage of participants | Radium-223 |
|---|---|
| Percentage of Participants With Bone Fractures | 9.7 (8.2 to 11.3) |
Bone associated events were identified by MedDRA HLGTs: Bone associated events: HLGT = "Bone disorders (excl congenital and fractures)"
| Percentage of participants | Radium-223 |
|---|---|
| Percentage of Participants With Bone Associated Events | 8.5 (7.1 to 10.0) |
Hematological toxicities were summarized by the Common Terminology Criteria for Adverse Events (CTCAE) coding system and the worst grade. The grading system ranges from Grade 1 (mild) to Grade 5 (death). The percentage of participants with post-radium-223 treatment CTCAE grade 3 or 4 hematological toxicities that occurred within 183 days from last radium-223 injection are reported
| Percentage | Radium-223 |
|---|---|
| Grade 3 | 14.74 (12.97 to 16.66) |
| Grade 4 | 1.77 (1.16 to 2.58) |
| Total | 15.42 (13.61 to 17.37) |
Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223
| Participants | Radium-223 |
|---|---|
| Abnormal platelet count (<50x10^9/L) — No | 398 |
| Abnormal platelet count (<50x10^9/L) — Yes | 49 |
| Abnormal platelet count (<50x10^9/L) — Missing | 1025 |
| Abnormal neutrophil count (<1x10^9/L) — No | 247 |
| Abnormal neutrophil count (<1x10^9/L) — Yes | 6 |
| Abnormal neutrophil count (<1x10^9/L) — Missing | 1219 |
Participants who receive subsequent cytotoxic chemotherapy were followed for the development of febrile neutropenia and hemorrhage up to 6 months after the last administration of chemotherapy at a frequency based on local clinical practice.
| Participants | Radium-223 |
|---|---|
| Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage | 23 |
Collected over After 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. Drug-related serious adverse events were collected up to 7 years. Adverse events reporting for all-cause mortality considers all death that occurred at any time during the study before the last contact, up to 7 years after last administration of Radium-223.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radium-223 | 1,308/1,472 (88.9%) | 325/1,472 (22.1%) | 837/1,472 (56.9%) |
| Event | Radium-223 |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 27/1472 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 16/1472 |
| General physical health deteriorationGeneral disorders | 15/1472 |
| PneumoniaInfections and infestations | 14/1472 |
| Spinal cord compressionNervous system disorders | 13/1472 |
| Back painMusculoskeletal and connective tissue disorders | 11/1472 |
| PainGeneral disorders | 10/1472 |
| ThrombocytopeniaBlood and lymphatic system disorders | 8/1472 |
| AstheniaGeneral disorders | 8/1472 |
| Bone painMusculoskeletal and connective tissue disorders | 8/1472 |
| Event | Radium-223 |
|---|---|
| DiarrhoeaGastrointestinal disorders | 203/1472 |
| NauseaGastrointestinal disorders | 189/1472 |
| FatigueGeneral disorders | 170/1472 |
| AnaemiaBlood and lymphatic system disorders | 168/1472 |
| Back painMusculoskeletal and connective tissue disorders | 86/1472 |
| Decreased appetiteMetabolism and nutrition disorders | 85/1472 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 73/1472 |
| VomitingGastrointestinal disorders | 67/1472 |
| AstheniaGeneral disorders | 62/1472 |
| PainGeneral disorders | 55/1472 |
| Age, Continuous(Years) | Radium-223 |
|---|---|
| Median | 73.0 (44 to 94) |
| Sex: Female, Male(Participants) | Radium-223 |
|---|---|
| Female | 0 |
| Male | 1472 |
| Ethnicity (NIH/OMB)(Participants) | Radium-223 |
|---|---|
| Hispanic or Latino | 170 |
| Not Hispanic or Latino | 1159 |
| Unknown or Not Reported | 143 |
| Race/Ethnicity, Customized(Participants) | Radium-223 |
|---|---|
| White | 1295 |
| Black or African American | 63 |
| Asian | 16 |
| Multiple | 2 |
| American Indian or Alaska Native | 1 |
| Not reported | 95 |
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