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

This study has been completed.

First Received: May 10, 2002 Last Updated: August 13, 2007 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00036556

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Atrasentan

U.S. FDA Resources

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

Ages Eligible for Study:	19 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036556

Show 236 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Gary Gordon, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M00-244
Study First Received:	May 10, 2002
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00036556 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hormone-Refractory Prostate Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009