Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer
- Assess whether treatment with valproic acid (a type I histone deacetylase inhibitor)
can alter the kinetics of prostate-specific antigen (PSA) progression in patients with
non-metastatic prostate cancer and biochemical progression.
- Determine the duration of PSA response.
- Assess the percentage of patients who achieve a complete response.
- Assess the percentage of patients who achieve a partial response.
- Assess the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (observation): Patients undergo observation according to standard of care.
- Arm II (valproic acid): Patients receive oral valproic acid twice daily for up to 1
year in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
Allocation: Randomized, Primary Purpose: Treatment
Percentage of patients exhibiting observed or predicted prostate-specific antigen (PSA) doubling time > 10 months after initiation of the study
Ronald Rodriguez, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|