A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy

Inclusion Criteria

INCLUSION CRITERIA:

- patients with prostate cancer who have just undergone prostatectomy,

- high risk of their cancer recurring (High risk is defined as at least a 50 percent
chance the cancer will return within three years after surgery.)

EXCLUSION CRITERIA:

- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or
any other anticancer therapy.

- Prior radiation therapy

- Patients receiving any concurrent therapy for cancer. This includes alternative
therapies

- Patients requiring concurrent treatment with corticosteroids, with the exception of
inhaled and topical corticosteroids.

- History of a malignancy other than prostate cancer

- Peripheral neuropathy >/= Grade 2

- Psychological, familial, sociological or geographical conditions which do not permit
treatment and/or medical follow-up required to comply with the study protocol

- Patients with a history of hypersensitivity reaction to products containing
Polysorbate 80 (Tween 80).