A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse

Exclusion Criteria

• •1. Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
• •1. infection,
• •2. cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, left ventricular ejection fraction (LVEF) \> grade 2,
• •3. uncontrolled diabetes mellitus,
• •4. current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
• •5. renal disease,
• •6. active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
• •7. known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) 70% or less of normal and O2 saturation of 88% or less at rest on room air).
• •2. Other prior malignancy within the last 5 years, except basal cell skin cancer
• •3. Physical or psychological condition that would preclude study compliance
• •4. Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
• •5. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• •6. Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
• •7. Previous pelvic irradiation that make prostatic irradiation impossible
• •8. Severe GI disorders precluding pelvic irradiation
• •9. Patients already included in another therapeutic trial involving an experimental drug
• •10. Individual deprived of liberty or placed under the authority of a tutor.
• •11. Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments