Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00038662
Collaborator
(none)
200
41
4.9
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
May 1, 2002
Outcome Measures
Primary Outcome Measures
- Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology Centers Of Alabama | Homewood, | Alabama | United States | 35205 |
| 2 | Alaska Clinical Research Center, LLC | Anchorage | Alaska | United States | 99508 |
| 3 | Arkansas Urologial Associates, PA | Little Rock | Arkansas | United States | 72205 |
| 4 | San Diego Urology Center | La Mesa | California | United States | 91942 |
| 5 | Western Clinical Research Inc | Torrance | California | United States | 90505 |
| 6 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 7 | Clinical Physiology Associates | Fort Myers | Florida | United States | 33916 |
| 8 | Southeastern Urological Center, PA | Tallahassee | Florida | United States | 32308 |
| 9 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 10 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231-1000 |
| 11 | Sheldon Freedman MD | Las Vegas | Nevada | United States | 89109 |
| 12 | VA Medical Center(111) | Reno | Nevada | United States | 89502 |
| 13 | Nevada Urology Associates | Reno | Nevada | United States | 89511 |
| 14 | Carolinas Medical Centre | Charlotte, | North Carolina | United States | 28204 |
| 15 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 16 | Urologic Specialists Of Oklahoma, Inc. | Tulsa, | Oklahoma | United States | 74104-5433 |
| 17 | Oregon Urology Specialists | Eugene | Oregon | United States | 97401 |
| 18 | Urological Assoc. of Lancaster | Lancaster | Pennsylvania | United States | 17604-3200 |
| 19 | University Of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15232 |
| 20 | Center for Urologic Care | West Reading, | Pennsylvania | United States | 19611 |
| 21 | Center for Urologic Care | West Reading | Pennsylvania | United States | 19611 |
| 22 | Ntouch Research Corporation | Dallas | Texas | United States | 75230 |
| 23 | Salt Lake Research | Salt Lake City | Utah | United States | 84124 |
| 24 | Jeffrey Frankel, M.D. | Seattle, | Washington | United States | 98166-3059 |
| 25 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
| 26 | Tom Baker Cancer Center | Calgary, | Alberta | Canada | T2N 4N2 |
| 27 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G1Z2 |
| 28 | Cal Andreou, MD | Surrey | British Columbia | Canada | V3V 1N1 |
| 29 | Can-Med Medical Research Inc | Victoria | British Columbia | Canada | |
| 30 | Bruce W. Palmer Urology Inc. | Kentville | Nova Scotia | Canada | B4N4K9 |
| 31 | The Male Health Centres | Barrie | Ontario | Canada | L4M 4S5 |
| 32 | Burlington Professional Centre | Burlington | Ontario | Canada | L7N 3V2 |
| 33 | Hamilton & District Urology Association | Hamilton, | Ontario | Canada | L8N 1T8 |
| 34 | London Health Sciences Centre | London | Ontario | Canada | N6A 4G5 |
| 35 | Quest Clinical Trials | Markham | Ontario | Canada | L6B1A1 |
| 36 | Guardian Medical Arts Bldg. | North Bay | Ontario | Canada | P1B4Z2 |
| 37 | Jack Barkin, MD | North York | Ontario | Canada | M6A 3B5 |
| 38 | The Male Health Centres | Oakville | Ontario | Canada | L6H 3P1 |
| 39 | Sunnybrook &Women's College Health Sciens Center | Toronto | Ontario | Canada | M4N 3M5 |
| 40 | Hopital Notre-Dame | Montreal | Quebec | Canada | H2L 4M1 |
| 41 | Chuq Pavillon Hotel-Dieu | Quebec | Canada | G1R 2J6 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Darryl Sleep, M.D., Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00038662
Other Study ID Numbers:
- M01-366
- NCT00084994
First Posted:
Jun 4, 2002
Last Update Posted:
Aug 15, 2006
Last Verified:
Aug 1, 2006