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

Inclusion 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