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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atrasentan
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers Of Alabama
  • Alaska Clinical Research Center, LLC
  • Arkansas Urologial Associates, PA
  • San Diego Urology Center
  • Western Clinical Research Inc
  • Georgetown University Medical Center
  • Clinical Physiology Associates
  • Southeastern Urological Center, PA
  • Northwestern University
  • Johns Hopkins Oncology Center
  • Sheldon Freedman MD
  • VA Medical Center(111)
  • Nevada Urology Associates
  • Carolinas Medical Centre
  • Cleveland Clinic Foundation
  • Urologic Specialists Of Oklahoma, Inc.
  • Oregon Urology Specialists
  • Urological Assoc. of Lancaster
  • University Of Pittsburgh
  • Center for Urologic Care
  • Center for Urologic Care
  • Ntouch Research Corporation
  • Salt Lake Research
  • Jeffrey Frankel, M.D.
  • University of Washington Medical Center
  • Tom Baker Cancer Center
  • Cross Cancer Institute
  • Cal Andreou, MD
  • Can-Med Medical Research Inc
  • Bruce W. Palmer Urology Inc.
  • The Male Health Centres
  • Burlington Professional Centre
  • Hamilton & District Urology Association
  • London Health Sciences Centre
  • Quest Clinical Trials
  • Guardian Medical Arts Bldg.
  • Jack Barkin, MD
  • The Male Health Centres
  • Sunnybrook &Women's College Health Sciens Center
  • Hopital Notre-Dame
  • Chuq Pavillon Hotel-Dieu

Outcomes

Primary Outcome Measures

Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2002
Last Updated
August 10, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00038662
Brief Title
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

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atrasentan
Primary Outcome Measure Information:
Title
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darryl Sleep, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers Of Alabama
City
Homewood,
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arkansas Urologial Associates, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
San Diego Urology Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Western Clinical Research Inc
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Southeastern Urological Center, PA
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Sheldon Freedman MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
VA Medical Center(111)
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Nevada Urology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Carolinas Medical Centre
City
Charlotte,
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Urologic Specialists Of Oklahoma, Inc.
City
Tulsa,
State/Province
Oklahoma
ZIP/Postal Code
74104-5433
Country
United States
Facility Name
Oregon Urology Specialists
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Urological Assoc. of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
Facility Name
University Of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Center for Urologic Care
City
West Reading,
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Center for Urologic Care
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Ntouch Research Corporation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Jeffrey Frankel, M.D.
City
Seattle,
State/Province
Washington
ZIP/Postal Code
98166-3059
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Tom Baker Cancer Center
City
Calgary,
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Cal Andreou, MD
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Can-Med Medical Research Inc
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Bruce W. Palmer Urology Inc.
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N4K9
Country
Canada
Facility Name
The Male Health Centres
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 4S5
Country
Canada
Facility Name
Burlington Professional Centre
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Hamilton & District Urology Association
City
Hamilton,
State/Province
Ontario
ZIP/Postal Code
L8N 1T8
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Quest Clinical Trials
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B1A1
Country
Canada
Facility Name
Guardian Medical Arts Bldg.
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B4Z2
Country
Canada
Facility Name
Jack Barkin, MD
City
North York
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
The Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Sunnybrook &Women's College Health Sciens Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Chuq Pavillon Hotel-Dieu
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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