Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer
NCT ID: NCT02749825
Last Updated: 2016-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
41 participants
INTERVENTIONAL
2002-09-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trelstar
Per prescribing information
Trelstar
As labeled
Lupron
Per prescribing information
Lupron
As labeled
Zoladex
Per prescribing information
Zoladex
As labeled
Interventions
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Trelstar
As labeled
Lupron
As labeled
Zoladex
As labeled
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently taking Lupron or Zoladex
* Stable PSA
* Baseline testosterone below castration level
* Life expectancy \> 6 months
* Eastern Cooperative Oncology Group performance status of 0-2
* Signed, approved informed consent.
Exclusion Criteria
* Ongoing therapy with hyperprolactinemic agents
* Antiandrogen therapy within 28 days prior to study start
* Prior Orchiectomy, hypophysectomy or adrenalectomy
* Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
* Use of any investigational agent 3 months prior to enrollment
* Use of systemic corticosteroids within 28 days or during study
* Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
* Severe kidney or liver failure, based on adequate lab values
* Other medical conditions which would be likely to interfere with compliance or completion of study requirements
18 Years
MALE
No
Sponsors
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Manyak, Michael, M.D.
INDIV
Watson Pharmaceuticals
INDUSTRY
Pharmatech
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Michael Manyak, MD
Role: PRINCIPAL_INVESTIGATOR
Georege Washington University
Locations
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Arizona Urologic Specialists
Tucson, Arizona, United States
Heritage Physician Group - Urology Department
Hot Springs, Arkansas, United States
California Oncology of the Central Valley
Fresno, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
UroSearch
Ocala, Florida, United States
Scott A Slavis, MD, PC
Las Vegas, Nevada, United States
Shaukat M Qureshi, MD
Pennsville, New Jersey, United States
Brooklyn Heights Urology Associates
Brooklyn, New York, United States
Jazrawi-Atallah, P.C.
Brooklyn, New York, United States
Albemarle Urology Clinic, PA
Albemarle, North Carolina, United States
Raj P. Chopra MD, PC
Bloomsburg, Pennsylvania, United States
Countries
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Related Links
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Pharmatech - The Research Link website
Other Identifiers
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PUI-02809
Identifier Type: -
Identifier Source: org_study_id
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