Clinical Trial Details

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Study ID 121451
Stephen Howell, MD,   University of California Medical Center
Title Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
Conditions Prostate Cancer
Interventions Drug: rituximab
Phase Phase 0
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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).
  • Study Location
    Moores UCSD Cancer Center
    La Jolla, California, 92093-0698
    Contact N/A

    Information obtained from, on 7/30/2015. For additional information about this and other clinical trials, visit
    Please refer to this study by its identifier: NCT01804712

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