Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Radiation therapy plus six months of hormone therapy is one standard way of treating men with
high-risk prostate cancer. In this study, we want to see whether or not adding the
chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has
shown a benefit in median survival when given to men who have become resistant to hormonal
therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Inclusion Criteria:

- Biopsy proven prostate cancer

- Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score
equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible
patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any
minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal
Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive

- Negative bone scan

- Lymph node assessment by CT or MR

- Adequate hematologic function (Blood Counts)

- Adequate liver functions (blood tests)

- ECOG performance Status 0 or 1

- Peripheral neuropathy must be =< grade 1

- PSA obtained within 3 months of entry

Exclusion Criteria:

- Prior history of malignancy that are < 5 years except for cancers found to be
"in-situ" and would not likely impact a patient's life expectancy with appropriate
medical management.

- Prior pelvic radiation therapy

- Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)

- Individuals unable to tolerate lying still 5 - 10 minutes

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 90.