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

Abbott941 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

941

Conditions

Prostatic Neoplasms

Interventions

AtrasentanDRUG

Eligibility

Sex: MALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (234)

Outcomes

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

Data from ClinicalTrials.gov

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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

...and 224 more locations