Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

Inclusion criteria

• Age ≥18yrs
• ECOG performance status ≤2
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Clinical or radiological evidence of metastatic disease
• Disease progression while receiving androgen deprivation therapy with an increase in PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1 week apart
• Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction in serum PSA after this therapy was initiated
• Baseline serum prostate-specific antigen (PSA)≥10ng/ml
• Total testosterone <50 ng/dL (<1.7 nmol/L)
• Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10.0 g/dl
• Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN
• Ability to understand and to sign consent for the study

Exclusion criteria

• Prior treatment for prostate cancer with chemotherapy or radioisotopes
• History of another cancer within the preceding five years (except basal or squamous-cell skin cancer or adequately treated superficial bladder cancer)
• Known or suspected brain or leptomeningeal metastases
• Symptomatic peripheral neuropathy of grade 2 or higher
• Major surgery within 4 weeks of start of trial treatment
• Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start of trial treatment
• Known hypersensitivity to trial treatment or hypersensitivity to any of its components
• Any concomitant drugs contraindicated for use with the trial treatment
• Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
• Any psychological, familial, sociological or other patient related factors that might preclude compliance with the study protocol