A Pilot Study of Rituximab Neoadjuvant Therapy in Patients With High Risk Prostate Cancer Scheduled to Undergo Radical Prostatectomy
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Histologic response rate after one cycle of rituximab
1 treatment cycle (28 days)
No
Stephen Howell, MD
Principal Investigator
University of California Medical Center
United States: Institutional Review Board
121451
NCT01804712
March 2013
March 2017
Name | Location |
---|---|
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |