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Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

This study has been completed.
Information provided by:
Abbott Identifier:
First received: June 3, 2002
Last updated: August 10, 2006
Last verified: August 2006
The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Condition Intervention Phase
Prostatic Neoplasms
Drug: Atrasentan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.

Estimated Enrollment: 200
Study Start Date: May 2002

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

Inclusion Criteria:

  • prostate adenocarcinoma,
  • radical prostatectomy,
  • PSA between 0.4 and 5 ng/mL,
  • PSADT < 1 year

Exclusion Criteria:

  • previous hormonal therapy,
  • salvage therapy to the pelvis within 3 months prior to randomization
  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: NCT00038662

  Show 41 Study Locations
Sponsors and Collaborators
Study Director: Darryl Sleep, M.D. Abbott
  More Information Identifier: NCT00038662     History of Changes
Obsolete Identifiers: NCT00084994
Other Study ID Numbers: M01-366
Study First Received: June 3, 2002
Last Updated: August 10, 2006

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017