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

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

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

Related Studies