Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gustave Roussy, Cancer Campus, Grand Paris
With
Sanofi
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Affiliated to a social security regimen ;
Male patients older than 18 years ;
Histologically confirmed adenocarcinoma of the prostate ;
Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
Serum testosterone \<0.50 ng/ml (1.7 nmol/L) ;
Progressive disease (PSA progression or radiological progression or clinical progression) ;
ECOG 0-2 ;
Information delivered to patient and informed consent form signed by the patient or his legal representative ;
Adequate organ or bone marrow function as evidenced by:
* Hemoglobin \>/= 10 g/dL
* Absolute neutrophil count \>/=1.5 x 109/L,
* Platelet count \>/=100 x 109/L,
* AST/SGOT and/or ALT/SGPT \</=1.5 x ULN;
* Total bilirubin \</=1.5 x ULN,
* Serum creatinine \</=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded
You may not be if
Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ;
Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ;
History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ;
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ;
Clareo Health | Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer
