Patients diagnosed with metastatic or high risk(PSA>100 or N1) prostate cancer. MedDRA version: 14.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Product Name: Jevtana
Product Code: EU/1/11/676/001
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Sponsors
SPCG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: • Histological proven prostate adenocarcinoma • Metastatic PC with measurable or evaluable disease or • High risk PC (PSA > 100) or • Node positive disease (N+) • No prior treatment for prostate cancer • Age ? 18 years • ECOG 0- ? • Estimated survival > 3 months • WBC ? 2000 / mm 3, neutrophils 1500 / mm 3, platelets ? 100,000 / mm 3 • Satisfactory liver function: bilirubin, transaminases = 1.5 times the upper limit of normal . • Satisfactory renal function: serum creatinine = 150 mol / l • Patient information and signature of informed consent. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 424
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: • Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA) • Severe peripheral neuropathy (CTC grade = 3) • Active infection or other serious underlying pathology that could prevent patients from receiving treatment • History of cancer within 5 years before inclusion in the study other than basal cell skin cancer. • Brain metastases, uncontrolled symptomatic or asymptomatic • Patient participating in another clinical trial protocol with a molecule during this experimental study • Evolutionary History of psychiatric illness. • Inability to undergo medical monitoring for geographical, social or psychological • Systemic treatment with high dose steroids • Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall survival between the two treatment options. Arm B: Hormone therapy alone, Arm A: Hormone therapy + Cabazitaxel 25 mg / m² / day on day 1 every 3 weeks continued if the patient has stable or responding disease to 10 cycles G-CSF use according to ASCO guidelines is recommended. Patients will be followed for overall survival for at least 36 months from the date of therapy initiation. ;Secondary Objective: To evaluate and compare - disease specific survival - progression free survival - treatment response - Find biomarkers for treatment response - Quality of Life (QoL) - Health economic aspects of the two treatments. ;Primary end point(s): Overall survival defined as the time from randomization to the date of death of any cause.;Timepoint(s) of evaluation of this end point: 36 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - progression free survival - disease specific survival - treatment respons - Find biomarkers for treatment response - Quality of Life (QoL) - Health economic aspects of the two treatments ;Timepoint(s) of evaluation of this end point: 36 month | — |
Countries
Sweden
Contacts
Public ContactUrologkliniken USÖ
Örebro läns landsting
Outcome results
None listed