This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel	Phase III

Further Study Details: 

Primary Outcomes: To determine if overall survival is increased
Secondary Outcomes: To determine if PSA doubling time is increased; To determine if PSA failure is decreased; To determine if cancer specific mortality is decreased
Expected Total Enrollment:  350

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) with prednisone 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).

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Biopsy proven prostate cancer
• Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 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.
• 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 non-melanoma skin cancer, cancer confirmed to a colonic polyp, carcinoma in situ of the bladder
• Prior pelvic radiation therapy
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00116142

Anthony V D''''Amico, MD, PHD      617-732-7936 
Marian J Loffredo, RN,BS,OCN      617-732-7936 

Massachusetts
      Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium), Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Anthony V. D''''Amico, MD, PhD,  Principal Investigator,  Dana-Farber Cancer Institute   

Study ID Numbers:  05-043
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 27, 2005
ClinicalTrials.gov Identifier:  NCT00116142
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05