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

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

Completed

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Prince Of Wales Hospital, Randwick, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrasentan

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
First posted: May 13, 2002
Registry last updated: Aug 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed