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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036543

Enrollment

1000

Registered

2002-05-13

Start date

2001-05-31

Completion date

Unknown

Last updated

2006-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Hormone-Refractory, Prostate Cancer

Brief summary

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

Interventions

DRUGAtrasentan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026