Docetaxel is a chemotherapy drug that is used to treat several different types of cancer.

On the 19th of May 2004, the United States Food and Drugs Administration (US FDA) approved the use of docetaxel injection (available as Taxotere from Aventis Pharmaceuticals) plus prednisolone for the treatment of advanced, androgen-independent prostate cancer, also called hormone refractory prostate cancer.

The safety and efficacy of this regimen was shown in a multi-center clinical trial of 1006 men with advanced refractory prostate cancer. The men were randomly assigned to receive one of mitoxantrone plus prednisone (control arm), weekly docetaxel plus prednisone, or docetaxel every three weeks plus prednisone. The main endpoint of the study was patient survival after treatment.

The researchers found that the men who received docetaxel once every three weeks in combination with prednisone had a significant survival advantage over those in the control arm, at a median of 18.9 months versus 16.5 months. The regimen that involved weekly doses of docetaxel plus prednisone did not offer any survival advantage over the control arm.

Adverse side effects were more common with the use of docetaxel every three weeks plus prednisone than with mitoxantrone plus prednisone. These side effects included fluid retention, vomiting, allergic reaction, fatigue, diarrhea, hair loss, nail changes and anorexia.

The approved dosing regimen for the management of prostate cancer with docetaxel is 75 mg per square metre of body surface area. It is given as a one-hour infusion once every three weeks in combination with 5 mg oral prednisone twice daily. The treatment is usually given in ten cycles.