Metastatic Castrate Refractory Prostate Cancer
Conditions
Interventions
Trade Name: Jevtana 60mg concentrate and solvent for solution for infusion
Product Name: Jevtana (cabazitaxel)
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed IN
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosis of histologically proven prostate adenocarcinoma, that is castrate refractory 2. Previously treated with up to 6 cycles of Docetaxel at the same time (defined as commencing within 3 months) as instigation of primary hormone therapy. 3. Confirmed biochemical, radiological or clinical progression. 4. Metastatic disease 5. Aged 18 or over 6. WHO performance status grade 0 to 2 7. Adequate organ function as evidenced by: --ANC >1.5 x109/L --WBC >3.0 x109/L --Haemoglobin >10g/dL --Platelet count >100,000/mm3 --Total bilirubin 30ml/min (calculated by EDTA clearance, 24h urine collection, or Cockcroft-Gault) --Available for long-term follow up --Patient’s written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 98
Exclusion criteria
Exclusion criteria: 1. Prior systemic therapy with other chemotherapy drugs 2. Metastatic brain disease or leptomeningeal disease 3. Previous extensive palliative radiotherapy to bone marrow, e.g. hemibody radiotherapy 4. Active grade =2 peripheral neuropathy (NCI CTC v 4) 5. Active infection requiring systemic antibiotic or anti-fungal medication 6. Patients with reproductive potential not implementing accepted and effective method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The STAMPEDE and GETUG-12 trials are evaluating the early use of docetaxel in high risk prostate cancer patients. Currently the standard of care in first line metastatic CRPC (mCRPC) is docetaxel, and as most of the patients enrolled in STAMPEDE will ultimately relapse with mCRPC and a majority of those relapsing would be fit for further chemotherapy, it is debatable whether further chemotherapy should be regarded as first line mCRPC chemotherapy or second line. The TROPIC trial, which compared cabazitaxel with mitoxantrone in patients previously treated with docetaxel, has shown a statistically significant survival advantage with cabazitaxel. In light of the positive results from the TROPIC trial, there is an opportunity to investigate the role of cabazitaxel as a second line treatment in patients with mCRPC, previously treated with docetaxel within STAMPEDE. Both cabazitaxel and abiraterone have recently been licensed for treatment of mCRPC in the second line setting. It is al;Secondary Objective: not applicable;Primary end point(s): Clinical Progression-free survival (CPFS). Clinical progression is defined as the earliest of the: • Date of occurrence of pain progression • Date of occurrence of a cancer-related skeletal-related event • Date of death from any cause;Timepoint(s) of evaluation of this end point: Estimates of time to progression and time to death will be calculated using the Kaplan-Meier method. Median and 6-month ‘survival’ estimates will be presented with confidence intervals. A hazard ratio of the treatment effect will be estimated and presented with 95% confidence intervals. Primary analysis is planned when all patients have a minimum of 12 months follow-up following registration. The final study analysis will take place when all patients have completed 24 months follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine: • Toxicity (National Cancer Institute Common Toxicity Criteria version 4) • Skeletal-related-event-free survival • Pain progression-free survival • PSA-progression free survival • Overall survival • Quality of life;Timepoint(s) of evaluation of this end point: The proportion of patients experiencing grade 3 and grade 4 toxicities on each arm will be reported as a proportion of i) all patients randomised in the trial and ii) all patients receiving at least one dose of treatment in the trial. Changes in pain score and QoL will be assessed using longitudinal methods of analysis and will account for informative dropout, including dropout for death. The final study analysis will take place when all patients have completed 24 months follow up. | — |
Countries
United Kingdom
Contacts
Public ContactMs Carey Hendron
Cancer Research UK Clinical Trials Unit, University of Birmingham
Outcome results
None listed