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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00036556
First Posted: May 13, 2002
Last Update Posted: August 15, 2007
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.
Information provided by:
Abbott
  Purpose
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

Condition Intervention Phase
Prostatic Neoplasms Drug: Atrasentan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 941
Study Start Date: June 2001
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


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

ClinicalTrials.gov Identifier: NCT00036556     History of Changes
Obsolete Identifiers: NCT00026455
Other Study ID Numbers: M00-244
First Submitted: May 10, 2002
First Posted: May 13, 2002
Last Update Posted: August 15, 2007
Last Verified: August 2007

Keywords provided by Abbott:
Hormone-Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Atrasentan
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action