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

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

Study population: 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.

Trial locations and contacts

68 sites in 20 countries.

About this study

Official title: Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Conditions

Metastatic Castration-resistant Prostate Cancer

Being tested

Radium-223 dichloride (Xofigo, BAY88-8223)

Keywords

Radium-223, CRPC, Phase IV, Safety study

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

  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.

What is being measured

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

1. 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

   Measured: 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

2. 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.

   Measured: 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

3. 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.

   Measured: 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

4. Number of Participants With Drug-related SAEs

   All drug-related SAEs were collected up to 7 years after the last administration of radium-223.

   Measured: 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

5. 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)

   Measured: 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

6. 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

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

7. 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

   Measured: From 30 days after last dose of Radium-223 up to 6 months after last dose

8. 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.

   Measured: From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy

Timeline

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

1. First posted19 May 2014 (estimated)
2. Study start20 Aug 2014
3. Primary completion2 Aug 2024
4. Study completion24 Oct 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
• More trials run by BayerThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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