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.
This is an open label, single institution, pilot study of rituximab neoadjuvant therapy in patients with high risk prostate cancer scheduled to undergo radical prostatectomy. Prior to prostatectomy, patients will receive one treatment cycle (28 days) of rituximab 375 mg/m2 intravenously once weekly. Patients will be scheduled to undergo radical prostatectomy within two weeks of completing study treatment. Tissue from prostatectomy will be used for immunohistochemistry (IHC) staining of pharmacodynamic markers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
Moores UCSD Cancer Center
La Jolla, California, United States
B-cell Density Stained Area
Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm\^2/mm\^2)
Time frame: 1 treatment cycle (28 days)
Prostate-specific Antigen (PSA)
Prostate-specific antigen (PSA)
Time frame: from Day 1 to Day 29
Change in Tumor B-cell Stained Area
Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm\^2/mm\^2)
Time frame: from Day 1 to Day 29
Tumor CD3+ T-cell Stained Area
Immunohistochemical staining of serial prostatectomy sections to measure the density of CD3+ T-cells as stained area (mm\^2/mm\^2)
Time frame: from Day 1 to Day 29
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