Clinical trial NCT00038662: Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-06-04
Enrollment: 200
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood,
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Urologial Associates, PA
state: Arkansas
city: La Mesa
country: United States
facility: San Diego Urology Center
state: California
city: Torrance
country: United States
facility: Western Clinical Research Inc
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urological Center, PA
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Las Vegas
country: United States
facility: Sheldon Freedman MD
state: Nevada
city: Reno
country: United States
facility: VA Medical Center(111)
state: Nevada
city: Reno
country: United States
facility: Nevada Urology Associates
state: Nevada
city: Charlotte,
country: United States
facility: Carolinas Medical Centre
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Tulsa,
country: United States
facility: Urologic Specialists Of Oklahoma, Inc.
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Urology Specialists
state: Oregon
city: Lancaster
country: United States
facility: Urological Assoc. of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh
state: Pennsylvania
city: West Reading,
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: West Reading
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Dallas
country: United States
facility: Ntouch Research Corporation
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Seattle,
country: United States
facility: Jeffrey Frankel, M.D.
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Calgary,
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: Cal Andreou, MD
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Medical Research Inc
state: British Columbia
city: Kentville
country: Canada
facility: Bruce W. Palmer Urology Inc.
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male Health Centres
state: Ontario
city: Burlington
country: Canada
facility: Burlington Professional Centre
state: Ontario
city: Hamilton,
country: Canada
facility: Hamilton & District Urology Association
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Markham
country: Canada
facility: Quest Clinical Trials
state: Ontario
city: North Bay
country: Canada
facility: Guardian Medical Arts Bldg.
state: Ontario
city: North York
country: Canada
facility: Jack Barkin, MD
state: Ontario
city: Oakville
country: Canada
facility: The Male Health Centres
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook &Women's College Health Sciens Center
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame
state: Quebec
city: Quebec
country: Canada
facility: Chuq Pavillon Hotel-Dieu
Study officials:
affiliation: Abbott
name: Darryl Sleep, M.D.
role: STUDY_DIRECTOR
References: