Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone: A Randomized Pilot Study
- Patients will be randomized to either receive Atrasentan alone or Atrasentan plus
- Patients receiving Atrasentan alone will receive this drug in pill form once daily for
12 weeks. Patients will have a physical exam, blood work, and a urine sample performed
once every other week during the first four weeks of medication administration. After
those two initial visits, they will return to the clinic once every 4 weeks to have the
same tests repeated. A bone scan and abdominal-pelvic CT Scan will be done every 12
- After the patient has been taking Atrasentan for 12 weeks, if the disease has not
progressed, they will begin combination treatment of Atrasentan and Zometa.
- Patients receiving Atrasentan plus Zometa, receive Zometa intravenously and then
immediately start Atrasentan orally once daily as long as they remain on the study.
Patients will return to the clinic twice over the first 4 weeks (once every other week)
to have a physical exam, blood work and urine test performed. After these two initial
visits, they will return to the clinic once every 4 weeks to have the tests repeated
and to receive another treatment of zometa. A bone scan and an abdominal-pelvic CT
Scan will be done once every 12 weeks.
- Patients participation in this study will last as long as the disease does not progress
and they are not experiencing any serious side effects.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.
Matthew Smith, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|