Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
First received: January 20, 2012
Last updated: July 11, 2014
Last verified: July 2014
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.
Drug: Radium-223 dichloride (BAY88-8223)
What is Expanded Access?
||Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Drug: Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
|Ages Eligible for Study:
||18 Years and older
|Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516762
||Bayer Study Director
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 20, 2012
||July 11, 2014
||United States: Food and Drug Administration
Keywords provided by Bayer:
Castrate resistant prostate cancer
Hormone refractory prostate cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 24, 2016
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Radium Ra 223 dichloride
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs