Thérapie néoadjuvante au Rituximab dans le cancer de la prostate à haut risque avant une prostatectomie radicale

Date de début de l'étude : 1 juillet 2013

Inclusion Criteria: Ability to understand and provide written informed consent. Patient has EITHER: A Kattan nomogram predicted probability of being disease free 5 years after surgery of < 60%, OR A Gleason sum ≥ 8. Indicated for radical prostatectomy. Note: candidates for radical prostatectomy are still eligible even if they have a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix A). Males aged ≥ 18 years. Adequate organ function as defined below measured within 21 days of study entry: Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9.0 g/dL White blood cell (WBC) count ≥ 3.0 x 109/L Biochemistry: Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2 x institution's upper limit of normal (ULN) Total bilirubin <1.5 times ULN Serum creatinine and blood urea nitrogen (BUN)<1.5 times ULN Na, K Cl, carbon dioxide (CO2), Ca, phosphate (PO4) within institutional limits Available prostate biopsy specimen which is evaluable for B lymphocyte count. Exclusion Criteria: Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding TURP), radiation therapy, or chemotherapy. Current or past use of investigational agents within 4 weeks of study enrollment. Evidence of metastatic disease on cross sectional imaging or bone scan. History of hepatitis B or C, hepatitis immunodeficiency virus (HIV), tuberculosis or a chronic infection of any type. Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology). Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing).