NCT00670046

Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer

Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating patients with progressive, non-metastatic prostate cancer.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	valproic acid	given orally
OTHER	standard of care follow-up	participant follow the standard of care for patient with metastatic prostate cancer

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-05-01
• Last updated: 2018-09-28
• Results posted: 2018-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study