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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036556

Enrollment

941

Registered

2002-05-13

Start date

2001-06-30

Completion date

Unknown

Last updated

2007-08-15

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

Conditions

Prostatic Neoplasms

Keywords

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.

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

* 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.

Design outcomes

Primary

Measure	Time frame
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.	Every 12 weeks

Countries

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

Outcome results

None listed

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