CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
rituximabdrug
Likely dose
rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01804712
NCT01804712Early Ph 1Completed
CompareCT.gov

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

Christopher Kane·interventional·Posted Mar 5, 2013·Updated Mar 12, 2026

In Brief

A Early Phase 1 clinical trial evaluating rituximab for Prostate Cancer. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2013
Enrollment StartJul 1, 2013
Primary CompletionJun 30, 2020
Study CompletionAug 6, 2020
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 13.3 years ago

Interventions

rituximabdrug

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).