Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Jean Perrin
The purpose of this study is to assess the pathological response rate in metastatic prostate cancer patients treated by : Docetaxel with a phytochemical
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Age \>18
WHO performance status 0-2
Life expectancy ≥ 3 months
Patients receiving androgen-suppressive therapy in the form of chirurgical castration by orchiectomy or pulpectomy,or medical by LHRH agonist or antagonist with or without anti-androgen or all treatment blocking non gonadic testosterone fraction
Resulting to testosteronemia \<0,5 ng/ml
Histologically confirmed adenocarcinomia of prostate cancer and documented hormone independant metastatic disease - defined by: objective progression with at least one measurable lesion and/or evaluable lesion according to RECIST criteria and /or a rise in PSA level ("rising PSA")
Total bilirubin ≤ upper limit of normal (ULN).
AST and ALT ≤ 1.5 times ULN. Alkaline phosphatase ≤ 2.5 times ULN.
Serum creatinine \< 140 µmol/L or creatinine clearance \> 60 mL/ min.
Neutrophil count \> 2.109 L-1.
Platelet count ≥ 100,000/mm3.
Hemoglobin ≥ 10 g/dL
Not previous chemotherapy, except Estracyt
No liver, kidney or heart failure link to treatment
No malabsorption syndrome or disease significantly affecting gastrointestinal function
Prior radiotherapies are permetted withing four weeks of the first study treatment and must be \< 25 % of the bone marrow, and all adverse events must be resolved
Prior surgery are permitted.
You may not be if
Age \< 18
History of psychiatric disorders including psychotic disorder, dementia or seizures that would prohibit the understanding, observance and giving of informed consent
Previous or concomitant other malignancies except basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy
Patients should not have symptomatic brain metastasis
Concurrent severe and/or uncontrolled co-morbid medical condition
Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade \> 2 dysphagia
Patients with uncontrolled infection
History of significant neurologic (i.e. peripheral neuropathy grade \> 2 using NCI-CTC criteria v3.0)
Patients should not have received NSAIDs or COX2 inhibitors within the three weeks prior to starting the study
Treatment with any investigational drug within 30 days prior to registration
Patients should not have current regimen containing dietary phytonutrients
