CClinicalTrials.gg
CompletedNCT00038662Updated Aug 15, 2006

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

A Phase 2 interventional study of Atrasentan in Prostatic Neoplasms, sponsored by Abbott. Completed at 41 sites in 2 countries. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2006-08-15.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years and older
Sex
Male
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Study 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).

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Conditions studied

  • Prostatic Neoplasms

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 200 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous hormonal therapy,
  • salvage therapy to the pelvis within 3 months prior to randomization
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

  • DrugAtrasentan
06

What researchers measure

Primary outcomes

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

07

Study locations

41 sites
  • Urology Centers Of Alabama
    Homewood,, Alabama 35205, United States
  • Alaska Clinical Research Center, LLC
    Anchorage, Alaska 99508, United States
  • Arkansas Urologial Associates, PA
    Little Rock, Arkansas 72205, United States
  • San Diego Urology Center
    La Mesa, California 91942, United States
  • Western Clinical Research Inc
    Torrance, California 90505, United States
  • Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Clinical Physiology Associates
    Fort Myers, Florida 33916, United States
  • Southeastern Urological Center, PA
    Tallahassee, Florida 32308, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Johns Hopkins Oncology Center
    Baltimore, Maryland 21231-1000, United States
  • Sheldon Freedman MD
    Las Vegas, Nevada 89109, United States
  • VA Medical Center(111)
    Reno, Nevada 89502, United States
  • Nevada Urology Associates
    Reno, Nevada 89511, United States
  • Carolinas Medical Centre
    Charlotte,, North Carolina 28204, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Urologic Specialists Of Oklahoma, Inc.
    Tulsa,, Oklahoma 74104-5433, United States
  • Oregon Urology Specialists
    Eugene, Oregon 97401, United States
  • Urological Assoc. of Lancaster
    Lancaster, Pennsylvania 17604-3200, United States
  • University Of Pittsburgh
    Pittsburgh, Pennsylvania 15232, United States
  • Center for Urologic Care
    West Reading,, Pennsylvania 19611, United States
  • Center for Urologic Care
    West Reading, Pennsylvania 19611, United States
  • Ntouch Research Corporation
    Dallas, Texas 75230, United States
  • Salt Lake Research
    Salt Lake City, Utah 84124, United States
  • Jeffrey Frankel, M.D.
    Seattle,, Washington 98166-3059, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • Tom Baker Cancer Center
    Calgary,, Alberta T2N 4N2, Canada
  • Cross Cancer Institute
    Edmonton, Alberta T6G1Z2, Canada
  • Cal Andreou, MD
    Surrey, British Columbia V3V 1N1, Canada
  • Can-Med Medical Research Inc
    Victoria, British Columbia, Canada
  • Bruce W. Palmer Urology Inc.
    Kentville, Nova Scotia B4N4K9, Canada
  • The Male Health Centres
    Barrie, Ontario L4M 4S5, Canada
  • Burlington Professional Centre
    Burlington, Ontario L7N 3V2, Canada
  • Hamilton & District Urology Association
    Hamilton,, Ontario L8N 1T8, Canada
  • London Health Sciences Centre
    London, Ontario N6A 4G5, Canada
  • Quest Clinical Trials
    Markham, Ontario L6B1A1, Canada
  • Guardian Medical Arts Bldg.
    North Bay, Ontario P1B4Z2, Canada
  • Jack Barkin, MD
    North York, Ontario M6A 3B5, Canada
  • The Male Health Centres
    Oakville, Ontario L6H 3P1, Canada
  • Sunnybrook &Women's College Health Sciens Center
    Toronto, Ontario M4N 3M5, Canada
  • Hopital Notre-Dame
    Montreal, Quebec H2L 4M1, Canada
  • Chuq Pavillon Hotel-Dieu
    Quebec, G1R 2J6, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00038662
Lead sponsor
Abbott
First posted
Jun 4, 2002
Start date
May 2002
Last update
Aug 15, 2006

Study contacts

Darryl Sleep, M.D.
study director · Abbott
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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