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

May 17, 2017 updated by: Stephen Howell, M.D.

A Pilot Study of Rituximab Neoadjuvant Therapy in Patients With High Risk Prostate Cancer Scheduled to Undergo Radical Prostatectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Moores UCSD Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rituximab
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
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).
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histologic response rate after one cycle of rituximab
Time Frame: 1 treatment cycle (28 days)
1 treatment cycle (28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in prostate-specific antigen (PSA)
Time Frame: from Day 1 to Day 29
from Day 1 to Day 29
Change in peripheral blood B cell number
Time Frame: from Day 1 to Day 29
from Day 1 to Day 29
Change in serum CXCL13 level
Time Frame: from Day 1 to Day 29
from Day 1 to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephen Howell, M.D.

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Stephen Howell, MD, University of California Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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