Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181558
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 10, 2010
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by:
Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma of the Prostate Drug: Atrasentan Drug: Zoledronic Acid (Zometa) Phase 2

Detailed Description:
  • 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.

Secondary Outcome Measures :
  1. To evaluate the effects of Atrasentan monotherapy and combination therapy with Atrasentan and Zometa on PSA doubling time.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00181558

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Matthew Smith, MD, PhD Massachusetts General Hospital

Responsible Party: Matthew R. Smith, MD, PhD, Massachusetts General Hospital, Boston, MA 02114 Identifier: NCT00181558     History of Changes
Other Study ID Numbers: 01-200
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by Massachusetts General Hospital:
Prostate Cancer
bone metastases
Androgen Independent Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action