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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.
- 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, Control: Active Control, Primary Purpose: Treatment
valproic acid, standard follow-up care
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:30:58-0400
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A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
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A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Specialized healthcare delivered as a follow-up or referral from a PRIMARY CARE provider.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...