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Complete title: A PhaseI/IIa Study of Safety and Efficacy of Alpharadin® with Docetaxel in Patients with Bone Metastases from Castration-Resistant Prostate Cancer
|Research Study Number||20121484|
|Principal Investigator||Tia Higano, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Male
- 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).
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Prostate Cancer; Solid Tumors
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