Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients (GERICO10)

This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic Prostate cancer, Elderly patients, Vulnerable and Frail (SIOG classification), castration-resistant Read More

Inclusion Criteria:

• Age >= 75
• Histologically proven prostate adenocarcinoma
• Metastatic disease, not pre-treated with chemotherapy refractory to castration

• Hormone refractory prostate cancer is defined as follows:

  • Patients with documented testosterone castration (<0.50 ng / ml)
  • Patient who received prior hormonal therapy (either orchidectomy or Luteinizing hormone-releasing hormone (LHRH) agonist alone or combined with an anti-androgen)
  • Patients should continue primary androgen suppression by LHRH agonist (in case of non-surgical castration)
  • For patients treated with anti-androgens prior to inclusion, a wash-out period is required (4 weeks for flutamide and nilutamide, 6 weeks for other products) as well as measured progression after anti-androgen discontinuation.
• Progressive disease under hormonotherapy, with progression defined by

Increase of PSA level (two consecutive increases of PSA compared to baseline with a minimum of one week between both measurements)

OR emergence of a new lesion

OR measurable progressive disease (increase of a previous measurable lesion >= 25% in cross section)

OR progressive bone metastases (defined only by the appearance of a new lesion on bone scan)

OR progressive symptoms (defined as cancer pain Grade 2 according to the NCI-CTC V4.0, despite level 2 analgesics intake).

• Patients of Groups 2 and 3 [ "vulnerable" and "frail"] of SIOG classification
• WHO Performance Status (PS) >= 3
• PSA >= 5 ng / ml
• Neutrophils >= 2.109 /L
• Platelets >= 100.109/L
• Haemoglobin ≥ 9 g/dl
• Bilirubin and SGOT / SGPT <1.5 x ULN (<= 2.5 x ULN if hepatic metastasis)
• creatinine <= 2.5 x ULN
• In case of previous palliative or analgesic radiotherapy, a minimum of 14 days must have elapsed between end of radiotherapy and inclusion into the study
• Previous treatment with bisphosphonates should be continued without change during the study treatment and can not be initiated either within 28 days prior to study entry or during the study
• Signed informed consent by patients, according to local regulations

Exclusion Criteria:

• "healthy" or "terminal illness" Groups according to the recommendations of International Society of Geriatric Oncology (SIOG)
• Concomitant or previous malignancy within 5 years prior the study (except basal or squamous in situ cell skin carcinoma)
• Presence of brain metastasis symptoms
• Prior treatment by intravenous radiopharmaceutical agent (e.g. Strontium 89, Samarium lexidronam) within 2 months before study entry
• Initiation of a bisphosphonate therapy within 28 days prior to randomisation
• Any concomitant anticancer treatment (radiotherapy, radiopharmaceutical agent, chemotherapy)
• Patients with uncontrolled infection
• Patients with peripheral neuropathy of grade> 1
• Patients medically unstable (e.g. unstable diabetes, uncontrolled hypertension or decompensated heart failure or myocardial infarct within 3 months)
• Gastro duodenal active ulcer
• Hypersensitivity to study drugs
• Treatment with any experimental drug within 30 days prior to or during the study
• Psychological, familial, sociological or geographical location conditions which do not allow medical monitoring and compliance with study protocol.
• Patients protected by the law or patients placed under protective supervision of adults