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

Prostatic Neoplasms Clinical Trial

Official title:

A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038662
• Other study ID #: M01-366
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2002
• Last updated: August 10, 2006
• Start date: May 2002

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Other known NCT identifiers

• NCT00084994

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Atrasentan

Locations

Country	Name	City	State
Canada	The Male Health Centres	Barrie	Ontario
Canada	Burlington Professional Centre	Burlington	Ontario
Canada	Tom Baker Cancer Center	Calgary,	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hamilton & District Urology Association	Hamilton,	Ontario
Canada	Bruce W. Palmer Urology Inc.	Kentville	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Quest Clinical Trials	Markham	Ontario
Canada	Hopital Notre-Dame	Montreal	Quebec
Canada	Guardian Medical Arts Bldg.	North Bay	Ontario
Canada	Jack Barkin, MD	North York	Ontario
Canada	The Male Health Centres	Oakville	Ontario
Canada	Chuq Pavillon Hotel-Dieu	Quebec
Canada	Cal Andreou, MD	Surrey	British Columbia
Canada	Sunnybrook &Women's College Health Sciens Center	Toronto	Ontario
Canada	Can-Med Medical Research Inc	Victoria	British Columbia
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Carolinas Medical Centre	Charlotte,	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ntouch Research Corporation	Dallas	Texas
United States	Oregon Urology Specialists	Eugene	Oregon
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Urology Centers Of Alabama	Homewood,	Alabama
United States	San Diego Urology Center	La Mesa	California
United States	Urological Assoc. of Lancaster	Lancaster	Pennsylvania
United States	Sheldon Freedman MD	Las Vegas	Nevada
United States	Arkansas Urologial Associates, PA	Little Rock	Arkansas
United States	University Of Pittsburgh	Pittsburgh	Pennsylvania
United States	Nevada Urology Associates	Reno	Nevada
United States	VA Medical Center(111)	Reno	Nevada
United States	Salt Lake Research	Salt Lake City	Utah
United States	University of Washington Medical Center	Seattle	Washington
United States	Jeffrey Frankel, M.D.	Seattle,	Washington
United States	Southeastern Urological Center, PA	Tallahassee	Florida
United States	Western Clinical Research Inc	Torrance	California
United States	Urologic Specialists Of Oklahoma, Inc.	Tulsa,	Oklahoma
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Center for Urologic Care	West Reading	Pennsylvania
United States	Center for Urologic Care	West Reading,	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.