Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone
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|ClinicalTrials.gov Identifier: NCT00181558|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Adenocarcinoma of the Prostate||Drug: Atrasentan Drug: Zoledronic Acid (Zometa)||Phase 2|
- Patients will be randomized to either receive Atrasentan alone or Atrasentan plus Zometa.
- 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 weeks.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone: A Randomized Pilot Study|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.
- To evaluate the effects of Atrasentan monotherapy and combination therapy with Atrasentan and Zometa on PSA doubling time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181558
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew Smith, MD, PhD||Massachusetts General Hospital|