A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

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.