Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

NCT ID: NCT00038662

Last Updated: 2006-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atrasentan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* prostate adenocarcinoma,
* radical prostatectomy,
* PSA between 0.4 and 5 ng/mL,
* PSADT \< 1 year

Exclusion Criteria

* previous hormonal therapy,
* salvage therapy to the pelvis within 3 months prior to randomization
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Darryl Sleep, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Urology Centers Of Alabama

Homewood, Alabama, United States

Site Status

Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Site Status

Arkansas Urologial Associates, PA

Little Rock, Arkansas, United States

Site Status

San Diego Urology Center

La Mesa, California, United States

Site Status

Western Clinical Research Inc

Torrance, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Clinical Physiology Associates

Fort Myers, Florida, United States

Site Status

Southeastern Urological Center, PA

Tallahassee, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Sheldon Freedman MD

Las Vegas, Nevada, United States

Site Status

VA Medical Center(111)

Reno, Nevada, United States

Site Status

Nevada Urology Associates

Reno, Nevada, United States

Site Status

Carolinas Medical Centre

Charlotte, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Urologic Specialists Of Oklahoma, Inc.

Tulsa, Oklahoma, United States

Site Status

Oregon Urology Specialists

Eugene, Oregon, United States

Site Status

Urological Assoc. of Lancaster

Lancaster, Pennsylvania, United States

Site Status

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Center for Urologic Care

West Reading, Pennsylvania, United States

Site Status

Ntouch Research Corporation

Dallas, Texas, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Jeffrey Frankel, M.D.

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Cal Andreou, MD

Surrey, British Columbia, Canada

Site Status

Can-Med Medical Research Inc

Victoria, British Columbia, Canada

Site Status

Bruce W. Palmer Urology Inc.

Kentville, Nova Scotia, Canada

Site Status

The Male Health Centres

Barrie, Ontario, Canada

Site Status

Burlington Professional Centre

Burlington, Ontario, Canada

Site Status

Hamilton & District Urology Association

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Quest Clinical Trials

Markham, Ontario, Canada

Site Status

Guardian Medical Arts Bldg.

North Bay, Ontario, Canada

Site Status

Jack Barkin, MD

North York, Ontario, Canada

Site Status

The Male Health Centres

Oakville, Ontario, Canada

Site Status

Sunnybrook &Women's College Health Sciens Center

Toronto, Ontario, Canada

Site Status

Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

Chuq Pavillon Hotel-Dieu

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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M01-366

Identifier Type: -

Identifier Source: org_study_id

NCT00084994

Identifier Type: -

Identifier Source: nct_alias