Prostatic NeoplasmsPhase 2NCT00038662
Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
A Phase 2 study testing Atrasentan in people with Prostatic Neoplasms, run by Abbott at 40 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Atrasentan
- How many people
- 200 participants
- Where
- 40 sitesin 2 countries
- Study dates
- May 2002to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prostate adenocarcinoma,
- radical prostatectomy,
- PSA between 0.4 and 5 ng/mL,
- PSADT < 1 year
Who cannot join
- previous hormonal therapy,
- salvage therapy to the pelvis within 3 months prior to randomization
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States24 sites
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-1000
Carolinas Medical Centre
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ntouch Research Corporation
Dallas, Texas, 75230
Oregon Urology Specialists
Eugene, Oregon, 97401
Clinical Physiology Associates
Fort Myers, Florida, 33916
Urology Centers Of Alabama
Homewood, Alabama, 35205
San Diego Urology Center
La Mesa, California, 91942
Urological Assoc. of Lancaster
Lancaster, Pennsylvania, 17604-3200
Sheldon Freedman MD
Las Vegas, Nevada, 89109
Arkansas Urologial Associates, PA
Little Rock, Arkansas, 72205
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15232
VA Medical Center(111)
Reno, Nevada, 89502
Nevada Urology Associates
Reno, Nevada, 89511
Salt Lake Research
Salt Lake City, Utah, 84124
Jeffrey Frankel, M.D.
Seattle, Washington, 98166-3059
University of Washington Medical Center
Seattle, Washington, 98195
Southeastern Urological Center, PA
Tallahassee, Florida, 32308
Western Clinical Research Inc
Torrance, California, 90505
Urologic Specialists Of Oklahoma, Inc.
Tulsa, Oklahoma, 74104-5433
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Center for Urologic Care
West Reading, Pennsylvania, 19611
Canada16 sites
The Male Health Centres
Barrie, Ontario, L4M 4S5
Burlington Professional Centre
Burlington, Ontario, L7N 3V2
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Hamilton & District Urology Association
Hamilton, Ontario, L8N 1T8
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, B4N4K9
London Health Sciences Centre
London, Ontario, N6A 4G5
Quest Clinical Trials
Markham, Ontario, L6B1A1
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
Guardian Medical Arts Bldg.
North Bay, Ontario, P1B4Z2
Jack Barkin, MD
North York, Ontario, M6A 3B5
The Male Health Centres
Oakville, Ontario, L6H 3P1
Chuq Pavillon Hotel-Dieu
Québec, Quebec, G1R 2J6
Cal Andreou, MD
Surrey, British Columbia, V3V 1N1
Sunnybrook &Women's College Health Sciens Center
Toronto, Ontario, M4N 3M5
Can-Med Medical Research Inc
Victoria, British Columbia
About this study
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
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).
- Conditions
- Prostatic Neoplasms
- Being tested
- Atrasentan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtrasentanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2002 (estimated)
- Study startMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Darryl Sleep, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038662
- Sponsor's protocol ID
- M01-366
- Status last verified
- Aug 2006
- First submitted
- 3 Jun 2002
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00038662
- Acronym / sponsor ID
- M01-366
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2002
- First posted
- 4 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- prostate adenocarcinoma,
- radical prostatectomy,
- PSA between 0.4 and 5 ng/mL,
- PSADT < 1 year
Key exclusion criteria (2 listed)
- previous hormonal therapy,
- salvage therapy to the pelvis within 3 months prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrasentan | Drug | – |
Primary outcome
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darryl Sleep, M.D. study director
Abbott
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atrasentan in people with Prostatic Neoplasms, run by Abbott at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.