Impact of cabazitaxel on metastatic bone disease in prostate cancer
- Conditions
- 1.Histologically or cytologically confirmed adenocarcinoma of prostate that is resistant to hormone therapy and previously treated with a docetaxel containing regimen.MedDRA version: 21.0Level: LLTClassification code 10001198Term: Adenocarcinoma of the prostate metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001253-41-IT
- Lead Sponsor
- GRUPPO ONCOLOGICO DELL'ITALIA MERIDIONALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 107
1.Histologically or cytologically confirmed adenocarcinoma of prostate that is resistant to hormone therapy and previously treated with a docetaxel containing regimen
2.At least one measurable bone metastasis showed with bone scan and radiological confirmed. A confirmed diagnosis of bone metastases to bone scanning will require a second imaging modality (CT, MRI, or plain radiograph)
3.Life expectancy > 3 months
4.Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107
1. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
2.Any previous hormonal therapy with abiraterone, enzalutamide, TAK 700 provided in post docetaxel setting. Abiraterone pre-docetaxel is allowed only if the last administration is more than 3 months before the study inclusion
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