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

Phase 3

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00036556
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2002-05-10
• Study First Submitted QC: 2002-05-10
• Study First Posted: 2002-05-13
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-13
• Last Update Posted: 2007-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 941

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (233)

Urology Centers Of Alabama; 🇺🇸 Homewood,, Alabama, United States

Alaska Clinical Research Center, LLC; 🇺🇸 Anchorage, Alaska, United States

Advanced Clinical Trials; 🇺🇸 Tucson, Arizona, United States

Arkansas Urologial Associates, PA; 🇺🇸 Little Rock, Arkansas, United States

Robin V. Smith, MD; 🇺🇸 Chula Vista, California, United States

Urology Associate Of Central California; 🇺🇸 Fresno,, California, United States

South Valley Medical Plaza; 🇺🇸 Gilroy, California, United States

San Diego Urology Center; 🇺🇸 La Mesa, California, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Hills, California, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Scroll for more (223 remaining)