A study, in patients with prostate cancer that has spread to the bones, investigating the efficacy of radium-223 dichloride given as a 50kBq/kg dose (55 kBq/kg after implementation of NIST update) every 4weeks or a 80kBq/kg dose (88 kBq/kg after NIST update) every 4 weeks in radium- 223 dichloride naive patients for 6 doses or as a 50kBq/kg (55 kBq/kg after NIST update) every 4 weeks to patients who have already been treated with a course of six doses of radium-223 dichloride
- Conditions
- Castration resistant prostate cancer with bone metastasisMedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003118-42-DE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 391
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Castration-resistant disease defined as:
a Serum testosterone level: = 50 ng/dL (1.7 nmol/L)
b Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
c Serum PSA progression defined as 2 subsequent increases in PSA over a previous reference value, with a PSA value of
= 2 ng/mL at the time of the second increase
OR
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method