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

Tracking Information

First Received Date ^ICMJE

May 10, 2002

Last Updated Date

August 13, 2007

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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-skelatal leisions, or an event due to metastatic prostate cancer.

Change History

Complete list of historical versions of study NCT00036556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Drug: Atrasentan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

941

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00036556

Responsible Party

Study ID Numbers ^ICMJE

M00-244

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Gary Gordon, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP