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

Part of paid clinical trials in La Jolla, California.

Sponsor
Christopher Kane
Study ID
NCT01804712
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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 Dates

First listed
Mar 5, 2013
Start date
Jul 31, 2013
Status verified
Feb 2026
Primary completion
Jun 30, 2020
Completion
Aug 6, 2020

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

B-cell Density Stained Area [ Time Frame: 1 treatment cycle (28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moores UCSD Cancer CenterLa JollaCalifornia92093-0698-

Find similar trials in La Jolla, CA

Nationwide
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By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Moores UCSD Cancer Center· La Jolla, CA

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