Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bipolar Androgen Therapy · 1 trial · 3 indications
To determine the radiographic progression-free survival (rPFS) of BAT-RAD in patients with mCRPC treated with at least one novel androgen receptor (AR) targeted treatment.
| Arm | Type | Description |
|---|---|---|
| Bipolar Androgen Therapy in addition to RADium-223 (RAD) | EXPERIMENTAL | Participants will receive Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD). |
| Name | Type | Description |
|---|---|---|
| radium-223 | RADIATION | Radium-223 is an alpha-particle-emitting bone-targeted therapy. All patients will receive Treatment with Radium-223 at a dose of 55 kBq per kilogram of body weight IV every 28 days, for 6 cycles, |
| Bipolar Androgen Therapy (BAT) | DRUG | All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity. |
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate confirmed by pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, \> 50% of the tumor must be adenocarcinoma. * Bone metastases as manifested by one or more...