Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Radium-223 Dichloride (Alpharadin) 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 (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
Inclusion Criteria:
Age ≥18 years of age
Histologically or cytologically confirmed prostate cancer
Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
Progressive disease is defined either by:
Life expectancy ≥ 6 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2
Adequate hematological, liver, and renal function
Exclusion Criteria:
Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
Presence of brain metastases
Lymphadenopathy exceeding 6 cm in short-axis diameter
Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
Any other serious illness or medical condition, such as but not limited to:
Fecal incontinence
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