patient preference between cabazitaxel and docetaxel in metastatic castrate-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: taxotere is the current standard first-line chemotherapy for mcrpc and may be used as second-line therapy in good responders in first-line (taxotere rechallenge). jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after taxotere and is now the standard second-line chemotherapy. taxotere and jevtana have different toxicity profiles. many patients who are receiving jevtana for second-line treatment indicate they prefer this agent over taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). this was not expected since jevtana in post-taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than taxotere in first-line setting. the study design of caba-doc is similar to that of the pisces trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. despite similar pfs improvements over placebo in phase iii trials, results clearly showed that patients preferred pazopanib over sunitinib. a randomized phase iii study is currently comparing the efficacy of taxotere and jevtana in first-line setting with overall survival as a primary end-point. assessing patient preference between jevtana and taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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 ; * prior treatment with taxotere or jevtana ; * pre-existing symptomatic peripheral neuropathy grade \> 2 (ctcae v4) ; * 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) ;