Prostate Cancer

The main purpose of this study is to establish a recommended dose of Alpharadin® to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

Main Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
• Known castration-resistant disease
• Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
• Life expectancy at least 6 months.
• Acceptable hematology and serum biochemistry screening values
• Eligible for use of docetaxel according to the product information (package insert or similar).

Main Exclusion Criteria:

• Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
• Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
• Has an immediate need for radiotherapy.
• Has received prior hemibody external radiotherapy .
• Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
• Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
• Has received more than ten previous infusions of docetaxel.
• Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
• Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
• Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
• Has received prior treatment with Alpharadin.
• Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
• Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
• Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
• Uncontrolled loco-regional disease.
• Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
• Has imminent or established spinal cord compression based on clinical findings and/or MRI.
• Unmanageable fecal incontinence.