Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: valproic acid; standard of care follow-up
Intervention description: given orally; participant follow the standard of care for patient with metastatic prostate cancer
Intervention MeSH terms: Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV 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.
    

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