Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer (PROTAXY)

This is an interventional treatment trial for Metastatic Prostate Cancer Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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