Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)

Exclusion Criteria

• •Excluded medical conditions:
• •1. More than 5 not previously locally treated bone metastases as diagnosed by bone scintigraphy;
• •2. Visceral or lymph node metastases above the pelvis as assessed by computed tomography (CT) (or other imaging modality) ;
• •3. History of HIV infection or chronic hepatitis B or C
• •4. Active clinically serious infections (\> grade 2 National Cancer Institute Common Terminology Criteria (NCI-CTC) version 4.03)
• •5. History of organ allograft
• •6. Patients undergoing renal dialysis
• •7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study if not in complete remission for at least 5 years since date of diagnosis treated treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
• •8. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •9. Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
• •10. Any other serious illness or medical condition
• •11. Fecal incontinence
• •12. Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
• •13. Known allergy to Radium-223 dichloride (i.e. to active substance or one of the constituents)
• •Excluded therapies and medications, previous and concomitant:
• •1. Anticancer chemo- or targeted therapy for CRPC
• •2. Radiotherapy for prostate cancer manifestations other than study treatment if not given with curative intent to prostate fossa and/or pelvic lymph nodes
• •3. Major surgery within 4 weeks of study entry.
• •4. Systemic therapy with radionuclides for the treatment of bone metastases
• •5. Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
• •6. Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 week of study entry
• •7. Investigational drug therapy outside of this trial during or within 4 weeks of study entry