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 an investigational small molecule being studied for the treatment of metastatic hormone-sensitive prostate cancer. It is currently in Phase 2 clinical development, with an active trial evaluating its use in patients with high-volume disease. The drug is not yet approved and remains under investigation.
Ra223 is a radiopharmaceutical that delivers targeted radiation to bone metastases. It mimics calcium and is taken up by bone, where it emits alpha particles that damage tumor cells. This mechanism is being studied in the context of metastatic hormone-sensitive prostate cancer.
Ra223 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic hormone-sensitive prostate cancer.
Ra223 is currently in Phase 2 clinical development. It is being studied in a single active trial for metastatic hormone-sensitive prostate cancer, with an enrollment target of 50 patients. The drug is investigational and has not yet received regulatory approval.
Ra223 is being evaluated in a Phase 2 clinical trial with the identifier NCT07717099, titled 'Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer.' The trial is not yet recruiting and is planned to enroll 50 male patients aged 18 years and older in Spain.
Yes, Ra223 is the same as radium-223. The drug is referred to by both names, with the clinical trial title using the full name 'Radium-223' while the drug is commonly abbreviated as Ra223 in scientific and regulatory contexts.