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Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00036556
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : August 15, 2007
Sponsor:
Information provided by:
Abbott

Brief Summary:
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Atrasentan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 941 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Study Start Date : June 2001

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer. [ Time Frame: Every 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been diagnosed with prostate cancer.
  • Have a rising PSA while on hormone therapy or following surgical castration.

Exclusion Criteria:

  • Have evidence of distant metastatic disease on screening bone scan or CT scan.
  • Have received cytotoxic chemotherapy.
  • Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.

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 ClinicalTrials.gov identifier (NCT number): NCT00036556


Locations
Show Show 234 study locations
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Gary Gordon, M.D. Abbott

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ClinicalTrials.gov Identifier: NCT00036556    
Obsolete Identifiers: NCT00026455
Other Study ID Numbers: M00-244
First Posted: May 13, 2002    Key Record Dates
Last Update Posted: August 15, 2007
Last Verified: August 2007
Keywords provided by Abbott:
Hormone-Refractory Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Atrasentan
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action