This is a single-arm, multicenter open label, international, phase II study of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) in men with metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC with progressive disease (radiographically and/or biochemically) who have been treated with gonadotropin-releasing hormone (GnRH)-analogue (LHRH agonists/antagonists) continuously or bilateral orchidectomy will be enrolled in this study. Previous antiandrogen therapies are permitted, but no more than one (such as abiraterone, enzalutamide, apalutamide, darolutamide). All patients will receive treatment with Radium-223 at a dose of 55 Kilobecquerel (kBq) per kilogram of body weight IV every 28 days, for 6 cycles, plus Testosterone Cypionate 400mg Intramuscular (IM) every 28 days, until progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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,
All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.
Amber Michalik
Baltimore, Maryland, United States
RECRUITINGMoinhos de Vento Hospital
Porto Alegre, Brazil
NOT_YET_RECRUITINGRadiographic progression-free survival (rPFS) of BAT-RAD
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.
Time frame: 24 months
PSA decline ≥ 50 percent rate (PSA50) of BAT-RAD
To determine the PSA decline ≥ 50% rate (PSA50) of BAT-RAD in patients with mCRPC in 24 months.
Time frame: 24 months
Change in alkaline phosphatase of BAT-RAD
To determine if the dynamics (change) of alkaline phosphatase of BAT-RAD in patients with mCRPC.
Time frame: Baseline and then on day one of each cycle (each cycle is 28 days), up to 9 cycles
PSA progression-free survival (PSA-PFS) of BAT-RAD
To determine the PSA progression-free survival (PSA-PFS) of BAT-RAD in patients with mCRPC in 24 months.
Time frame: 24 months
Time to disease progression of BAT-RAD
To determine the time to disease progression of BAT-RAD in patients with mCRPC measured in months.
Time frame: 24 months
Overall survival of BAT-RAD
To determine the overall survival of BAT-RAD in patients with mCRPC in 24 months.
Time frame: 24 months
Symptomatic skeletal event-free survival
To determine the symptomatic skeletal event-free survival in patients with mCRPC in 24 months.
Time frame: 24 months
Change in Quality of life as assessed by anxiety/depression EuroQol 5 dimensions 3 levels (EQ-5D-3L)
The EQ-5D-3L is made up of 5 questions each with 3 levels. The lowest level being none and the highest level being extreme. Overall score range of 3-15 with higher scores signifying worse quality of life.
Time frame: Baseline, cycle 4 day 1, cycle 7 day 1 and at the end of treatment, up to 28 days post cycle 9 (each cycle is 28 days)
Change in Quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P)
The (FACT-P) is made up of 39 question the scoring is between 0 and 156 with 0 being the best and 156 as the worst.
Time frame: Baseline, cycle 4 day 1, cycle 7 day 1 and at the end of treatment, up to 28 days post cycle 9 (each cycle is 28 days)
Change in Quality of life as assessed by the Brief Pain Inventory-Short Form (BPI-SF)
The Brief Pain Inventory-Short Form (BPI-SF) is 1 question 0 being the best and 10 being the worst.
Time frame: Baseline, cycle 4 day 1, cycle 7 day 1 and at the end of treatment, up to 28 days post cycle 9 (each cycle is 28 days)
Safety of BAT-RAD in patients with mCRPC as assessed by number of participants removed for adverse events
To determine the safety of BAT-RAD in patients with mCRPC in patients with mCRPC compared with standard of care treatment for this patient population. This will be measured through Physical assessment, adverse events and labs and will be measured by how many patients are removed for adverse events.
Time frame: Up to 10 months
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