Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00670046|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 1, 2008
Last Update Posted : February 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: valproic acid Procedure: standard follow-up care||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||April 2009|
No Intervention: Arm I (observation)
Patients undergo observation according to standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
Procedure: standard follow-up care
Experimental: 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.
Drug: valproic acid
- Percentage of patients exhibiting observed or predicted prostate-specific antigen (PSA) doubling time > 10 months after initiation of the study
- Duration of PSA response
- Percentage of patients who achieve a complete response
- Percentage of patients who achieve a partial response
- Self-perceived functionality, psychosocial well-being, and quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670046
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231-2410|
|Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 email@example.com|
|Principal Investigator:||Ronald Rodriguez, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|