Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy

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).