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

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

Completed

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

St Vincent's Clinic, Darlinghurst, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Atrasentan

Drug

Primary outcomes

The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start: 2001
First posted: May 13, 2002
Registry last updated: Aug 15, 2006

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