Stephen Howell, MD, University of California Medical Center
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
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.
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
- 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:
- 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
- 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.
- 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
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology
Moores UCSD Cancer Center
La Jolla, California, 92093-0698
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Information objtained from ClinicalTrials.gov, on
9/30/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: