A Pilot Study of Rituximab Neoadjuvant Therapy in Patients With High Risk 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, 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).