Prostate Cancer Clinical Trial
Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Asymptomatic, non-metastatic disease
Biochemical progression after definitive local therapy (radical prostatectomy)
Most recent prostate-specific antigen (PSA) level ≥ 1.0 ng/mL AND rising over the prior value
No clinical or radiological evidence of local progression
PSA doubling time (DT) < 10 months after local therapy (in patients who have not received prior hormone therapy)
At least three PSA values (each at least 4 weeks apart) are required to calculate the PSA-DT
No clinical or radiological evidence of metastatic disease, including bone metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 3 months
Total bilirubin normal
AST/ALT < 2.5 times upper limit of normal
Creatinine ≤ 2.5 mg/dL
Platelet count > 125,000/mm^3
PT and aPTT ≤ 1.3 times above the standard reference
Albumin ≥ 3.5 g/dL
Geographically accessible and willing to participate in all stages of study treatment
No active second malignancy
No known HIV positivity
No active, uncontrolled infection (e.g., hepatitis A, B, or C infection)
No history of allergic reactions attributed to compounds of similar chemical or biological composition to valproic acid
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal study treatment and follow-up
No history of hepatic disease or significant hepatic dysfunction
No history of pancreatitis
No history of seizure disorder or clinically treated bipolar disorder
PRIOR CONCURRENT THERAPY:
More than 6 months since prior hormone therapy
No prior valproic acid
At least 2 weeks since prior drugs specifically known to interact with valproic acid including, but are not limited to, aspirin, felbamate, rifampin, amitriptyline/nortriptyline, carbamazepine, clonazepam, diazepam, ethosuximide, lamotrigine, phenobarbital, primidone, phenytoin, tolbutamide, warfarin, or zidovudine
No concurrent systemic chemotherapy for prostate cancer
No other concurrent investigational drugs
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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