Assessing PSA Response in Low Dose Ketoconazole in Hormone Refractory Prostate Cancer Patients Who Have Failed at Least One Prior Systemic Chemotherapy Regimen
The aim of the study is to research the response of low dose ketoconazole in hormone
refractory prostate cancer (HRPC) patients who have already undergone chemotherapy as part
of their prostate cancer treatment. The hypothesis of the study is that HRPC patients who
have been previously treated with chemotherapy will demonstrate objective PSA response rates
to low dose ketoconazole, comparable to historical response rates reported in
chemotherapy-naïve patients. This is a single arm trial, with all participants given
ketoconazole 200mg TID, along with hydrocortisone given at 20mg in the morning, 10mg at
night daily. Each cycle will consist of 28 days. The subject's study participation will
continue until subject experiences disease progression, unacceptable toxicities, withdraws
consent for the study or dies.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.
Every Cycle (4 weeks)
Yes
Primo N Lara Jr., MD
Principal Investigator
University of California, Davis Health System
United States: Institutional Review Board
200916901
NCT00895310
May 2009
June 2014
Name | Location |
---|---|
University of California, Davis Cancer Center | Sacramento, California 95817 |