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

Completed · Early Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01804712

Run by

Christopher Kane

People needed

8

Starts

2013-07-01

Expected to finish

2020-08-06

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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