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

NCT01804712 | Completed Early Phase 1 Results DMC

• 1 other identifier: 121451
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Castration-resistant; Rituximab; neoadjuvant; Rituxan

Outcome Measures

Primary Outcomes (1)

• 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)

  1 treatment cycle (28 days)

Secondary Outcomes (3)

• Prostate-specific Antigen (PSA)

  from Day 1 to Day 29

• Change in Tumor B-cell Stained Area

  from Day 1 to Day 29

• Tumor CD3+ T-cell Stained Area

  from Day 1 to Day 29

Study Arms (1)

rituximab

EXPERIMENTAL

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).

Drug: rituximab

Interventions

rituximab DRUG

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).

Also known as: Rituxan

rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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).

Sponsors & Collaborators

• Christopher Kane: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093-0698, United States

Location

Related Publications (1)

• Ryan ST, Zhang J, Burner DN, Liss M, Pittman E, Muldong M, Shabaik A, Woo J, Basler N, Cunha J, Shalapour S, Estrada MV, Karin M, Messer K, Howell S, Kane CJ, Jamieson CAM. Neoadjuvant rituximab modulates the tumor immune environment in patients with high risk prostate cancer. J Transl Med. 2020 May 28;18(1):214. doi: 10.1186/s12967-020-02370-4.

  PMID: 32466781 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Christopher Kane
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Stephen Howell, MD

  University of California Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: July 1, 2013
• Primary Completion: June 30, 2020
• Study Completion: August 6, 2020
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Locations

US (1)