Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ra223 · 1 trial · 1 indication
Measured as the total number of cycles administered to each patient. Patients will be categorized in two groups, complete treatment compliance (complete ≥5 cycles of Ra223) and incomplete treatment compliance (complete \<5 cycles of Ra223). The proportion of patients in each category and their 95% confidence interval (CI) calculated by Clopper-Pearson will be given.
| Arm | Type | Description |
|---|---|---|
| QUANTUM intervention | EXPERIMENTAL | Six intravenous administrations of Radium-223 chloride, in a dose of 55 kBq/kg body weight standard dose with a treatment interval between administrations of 4 weeks. Treatment with Ra223 could be prematurely discontinued in case of progression, unacceptable toxicity, withdrawal or death. Patients received backgrount therapy with ADT and darolutamide |
| Name | Type | Description |
|---|---|---|
| Ra223 | DRUG | Six intravenous administrations of Radium-223 chloride, in a dose of 55 kBq/kg body weight standard dose with a treatment interval between administrations of 4 weeks. Treatment with Ra223 could be prematurely discontinued in case of progression, unacceptable toxicity, withdrawal or death. |
| Darolutamide Oral Tablet | DRUG | Darolutamide at 600 mg twice daily. Darolutamide administration will continue until progression, unacceptable toxicity, withdrawal or death, whichever comes first. |
| Androgen Deprivation Therapy (ADT) | OTHER | Standard of care ADT (surgical or drug). Administration will continue until progression, unacceptable toxicity, withdrawal or death, whichever comes first. |
INCLUSION CRITERIA Subjects must fulfill all of the following inclusion criteria to be eligible for enrollment to the study: 1. Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment. 2. Patients ≥18 years old. 3. ECOG performa...
Ra223 is being studied for metastatic hormone-sensitive prostate cancer, a form of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The research focuses on patients with high-volume disease. It is an investigational therapy and has not been approved for this use.
Ra223 is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is running the clinical program evaluating the agent in prostate cancer.
Ra223 is in Phase 2 clinical development. One Phase 2 trial is registered, and it has not yet begun recruiting participants. The study is designed to enroll 50 patients.
One registered trial is evaluating Ra223: NCT07717099, titled Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer. It is a Phase 2 study with a planned enrollment of 50 male patients aged 18 and older, and it is being conducted in Spain.
Ra223 is investigational and remains in clinical development. It is being tested in a Phase 2 trial for metastatic hormone-sensitive prostate cancer and has not completed the regulatory process for that indication. No approval for this use has been granted.
The Phase 2 trial NCT07717099 is an uncontrolled, open-label study, meaning it does not use a placebo or comparator group and is not blinded. It plans to enroll 50 male participants aged 18 years or older with high-volume metastatic hormone-sensitive prostate cancer in Spain.