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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 10, 2002
Last updated: August 10, 2006
Last verified: August 2006
This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

Condition Intervention Phase
Prostate Cancer
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 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression

Estimated Enrollment: 1000
Study Start Date: May 2001

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

Inclusion Criteria:

  • Diagnosis of prostate cancer.
  • Rising PSA while on hormonal therapy or following surgical castration.
  • Documented evidence of metastatic disease.

Exclusion Criteria:

  • 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 ClinicalTrials.gov identifier: NCT00036543

  Show 233 Study Locations
Sponsors and Collaborators
Study Director: Darryl Sleep, M.D. Abbott
  More Information

ClinicalTrials.gov Identifier: NCT00036543     History of Changes
Obsolete Identifiers: NCT00026481
Other Study ID Numbers: M00-211 
Study First Received: May 10, 2002
Last Updated: August 10, 2006
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

ClinicalTrials.gov processed this record on April 27, 2016