Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Radium-223 dichloride (BAY88-8223)
Ages Eligible For Study:
- Age ? 18 years - Histologically or cytologically confirmed prostate cancer - Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed) - Symptomatic is defined as either - Regular (not occasional) use of analgesic medication for cancer related bone pain (? level 1; World Health Organization [WHO] ladder for cancer pain), or - Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment) - Progressive disease is defined either by: - The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR - In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ? 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met). - No intention to use cytotoxic chemotherapy within the next 6 months - Life expectancy ? 6 months - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 - Adequate hematological, liver, and renal function - Absolute neutrophil count (ANC) ? 1.5 x10^9/L - Platelet count ? 100 x10^9/L - Hemoglobin ? 10.0 g/dL (100 g/L; 6.2 mmol/L) - Total bilirubin level ? 1.5 x institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN - Creatinine ? 1.5 x ULN - Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care