Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

Completed · Phase 2

Conditions studied: Prostate Cancer, Adenocarcinoma of the Prostate

In brief

The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.

Key facts

Study ID

NCT00181558

Run by

Massachusetts General Hospital

People needed

44

Starts

2001-12-01

Expected to finish

2006-12-01

Last updated by the study team

2010-05-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• History of bilateral orchiectomy or current treatment with a GnRH agonist or antagonist
• Radiographically documented bone metastases
• Disease progression according to criteria from the PSA Working Group

You may not qualify if…

• Prior treatment with Atrasentan or Zometa within one year
• Serum creatinine > 2.0mg/dL
• Documented cardiovascular disability status of New York Heart Association Class 2
• Treatment with chemotherapy, radiation, steroids, estrogens, or PC-SPES within 6 weeks
• Treatment with bisphosphonates or radiopharmaceuticals within 12 weeks
• History of Paget's disease, hyperthyroidism, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia or other disorder associated with metabolic bone disease.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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