Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Phase 2
47
about 4.8 years
18+
Male only
1 site in MD
What this study is about
This trial is testing a treatment of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) for men with metastatic castration-resistant prostate cancer. Men who have received hormone therapy and whose cancer has returned will be enrolled in it, which involves giving Radium-223 every 28 days for six cycles along with Testosterone Cypionate injections until the treatment causes unacceptable side effects or the cancer progresses.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive radium-223
- 2.Take Bipolar Androgen Therapy (BAT)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Radiographic progression-free survival (rPFS) of BAT-RAD
Secondary: Change in Quality of life as assessed by anxiety/depression EuroQol 5 dimensions 3 levels (EQ-5D-3L), Change in Quality of life as assessed by the Brief Pain Inventory-Short Form (BPI-SF), Change in Quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P), Overall survival of BAT-RAD, PSA progression-free survival (PSA-PFS) of BAT-RAD, Safety of BAT-RAD in patients with mCRPC as assessed by number of participants removed for adverse events, Symptomatic skeletal event-free survival, Time to disease progression of BAT-RAD