A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the prostate
Known castration-resistant disease
Serum PSA ≥2 ng/mL (μg/L)
Multiple skeletal metastases (≥2 hot spots) on bone scan
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
Life expectancy ≥6 months
Adequate hematologic, hepatic, and renal function
You may not be if
History of visceral metastasis, or visceral metastases
Malignant lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
Medical condition that would make prednisone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
Treatment with more than one chemotherapy agent for prostate cancer
Prior systemic radiotherapy and hemibody external radiotherapy
History of pituitary or adrenal dysfunction
Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
Central nervous system (CNS) metastases
Clareo Health | A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
