Impact of cabazitaxel on metastatic bone disease in prostate cancer

Impact of cabazitaxel on metastatic bone disease in patients with castration resistant prostate cancer previously treated with docetaxel - CABONE STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001253-41-IT

Enrollment

107

Registered

2021-02-09

Start date

2018-03-12

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 21.0 Level: LLT Classification code 10001198 Term: Adenocarcinoma of the prostate metastatic System Organ Class: 100000004864

Interventions

Trade Name: JEVTANA - 60MG-CONCENT. E SOLV.PER SOLUZ. PER INFUSIONE-USO ENDOVENOSO -CONCENT.:FLACONC.(VETRO)SOLV.: FLACONC.(VETRO)-CONCENT.:1.5ML SOLV.:4.5ML-1FLAC.+1FLAC. Product Name: CABAZITAXEL Pr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Bone Progressione Free Survival;Secondary Objective: Analysis of effect on bone turnover markers, time to bone pain progression, bone pain response; ;Primary end point(s): Bone (Skeletal) PFS;Timepoint(s) of evaluation of this end point: Whole duration of the study	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Analysis of effect on Bone turnover markers;Timepoint(s) of evaluation of this end point: Whole duration of the study	—

Countries

Italy

Contacts

Public ContactClinical Trial Center

Gruppo Oncologico dell'Italia Meridionale ( GOIM)

trialsgoim@gmail.com3409404826

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026