Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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 or MRI 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.
