SWOG 0421

Principal Investigator:	Seth Cohen, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
Drugs such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

Eligibility and Treatment Plan:
Male patients = 18 years, with histologically diagnosed adenocarcinoma of the prostate with evidence of bone metastases, and be unresponsive or refractory to hormone therapy.

Patients will randomly be assigned to one of the two study arms (12 cycles/36 weeks):
Arm A) Docetaxel + Atrasentan + Prednisone
Arm B) Docetaxel + Placebo + Prednisone.

Benefits and/or Compensation:
Participants will receive the investigational agent Atrasentan or placebo at no charge under the supervision and care of a team of medical professionals. Patients and/or their health plan will need to pay for some or all the costs of treating your cancer in this study. The information gathered from this study may be beneficial to future patients, and atrasentan + docetaxel may improve the overall survival of patients with HRPC.