Clinical trial · Interventional
Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
Randomized, Controlled Phase II Study of Valproic Acid in Patients With Non-metastatic Biochemical Progression of Prostate Cancer
NCT00670046CI-TRIAL-00035068terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated per the PI decision.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard of care follow-up | Other | — | UNRESOLVED |
| valproic acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm I (standard of care)
- description
- Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
- interventionNames
- Other: standard of care follow-up
- type
- EXPERIMENTAL
- label
- Arm II (valproic acid)
- description
- 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.
- interventionNames
- Drug: valproic acid
Primary outcomes (1)
- measure
- Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.