Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer

A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer

Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.

Upon determination of eligibility, patients will be receive:

• Docetaxel + Bortezomib

Patients with objective responses or stable disease will continue treatment for eight courses or until disease progression is documented.

Inclusion Criteria:

• Prostate cancer, and objective evidence of metastatic disease
• Progression while receiving androgen ablation therapy
• No previous chemotherapy
• Measurable or evaluable disease in conjunction with elevated serum PSA levels
• ECOG performance status 0, 1, or 2
• Adequate bone marrow, liver and kidney function
• Voluntarily provide written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Moderate or severe peripheral neuropathy
• Age < 18 years
• Other serious medical conditions that may interfere with protocol therapy
• Other active malignancies
• history of treatment for other invasive cancers within 3 years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.