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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: May 10, 2002
Last updated: August 13, 2007
Last verified: August 2007
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00036556

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

No publications provided Identifier: NCT00036556     History of Changes
Obsolete Identifiers: NCT00026455
Other Study ID Numbers: M00-244 
Study First Received: May 10, 2002
Last Updated: August 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hormone-Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 04, 2016