Early Phase 1
N=8
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01804712 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Mar 2026
Primary outcome: Primary: B-cell Density Stained Area — 0.027 mm^2/mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Christopher Kane
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY B-cell Density Stained Area |
0.027 | — |
| SECONDARY Prostate-specific Antigen (PSA) |
8.1; 8.36 | — |
| SECONDARY Change in Tumor B-cell Stained Area |
-0.005 | — |
| SECONDARY Tumor CD3+ T-cell Stained Area |
0.022 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01804712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.