EUCTR2013-003118-42-ITActive, not recruitingPhase 1
A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg versus 80 kBq/kg, and versus 50 kBq/kg in an extended dosing schedule in subjects with castration-resistant prostate cancer metastatic to the bone
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer HealthCare AG
- Enrollment
- 391
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Histologically or cytologically confirmed adenocarcinoma of the prostate
- •- Castration-resistant disease defined as:
- •-- Serum testosterone level: = 50 ng/dL (1.7 nmol/L)
- •-- Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
- •-- Serum PSA (Prostate specific sntigen) progression defined as 2 subsequent increases in PSA over a
- •previous reference value (a minimum of 2 ng/mL [µg/L])
- •-- Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression
- •- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone.
- •- Two or more skeletal metastases (= 2 hot spots) on bone scintigraphy within 8 weeks of randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
Exclusion Criteria
- •- History of visceral metastasis, or visceral metastases
- •- Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
- •- Central nervous system (CNS) metastases
- •- Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to
- •randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the
- •treatment period or follow-up
- •- Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone)
- •- Prior treatment with radium-223 dichloride
- •- Prior systemic radiotherapy and hemibody external radiotherapy
Investigators
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