Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
NCT ID: NCT01630967
Last Updated: 2012-06-28
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2012-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Degarelix
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Interventions
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Degarelix
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* currently receiving LHRH agonist
* Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
* PSA \> 2 ng/ml
* rising PSA despite LHRH agonist
* patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
* Prior chemotherapy allowed
* ECOG performance status 0-1
Exclusion Criteria
* Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
British Columbia Cancer Agency
OTHER
Responsible Party
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Kim Chi
Associate Professor of Medicine, University of British Columbia
Principal Investigators
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Kim N Chi, MD
Role: PRINCIPAL_INVESTIGATOR
British Columbia Cancer Agency, Univeristy of British Columbia
Locations
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British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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References
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Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.
Other Identifiers
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BCCA_Deg01
Identifier Type: -
Identifier Source: org_study_id
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