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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13 released by the tumor cells. B cells release lymphotoxin which drives malignant cell proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine whether depletion of B cells by rituximab will result in a decrease in the extent of B cell infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy will be compared to that in the prostatectomy samples following administration of 4 weekly doses of rituximab.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephen Howell, M.D.
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

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).