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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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2012-08-31
2015-11-30
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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Degarelix
Degarelix Alone
Degarelix
Degarelix + Casodex
Degarelix and Casodex
Degarelix
Casodex
LHRH Agonist + Casodex
LHRH Agonist and Casodex
Casodex
LHRH Agonist
Interventions
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Degarelix
Casodex
LHRH Agonist
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent, either alone or with the aid of a translator
* Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
* Gleason Score \>= 7and/or prostate cancer that is clinical stage T2 disease.
* Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
* Normal organ and marrow function as defined by the following criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria
* History of receiving radiation to the pelvic area.
* Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
* Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms).
* History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
* Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
* Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
* Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
* Mental incapacity or language barrier precluding adequate understanding or co operation.
* Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
* Previously participated in any degarelix trial.
18 Years
75 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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References
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Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Sayyid RK, Evans A, Hersey K, Maloni R, Hurtado-Coll A, Kulkarni G, Finelli A, Zlotta AR, Hamilton R, Gleave M, Fleshner NE. A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy. Clin Cancer Res. 2017 Apr 15;23(8):1974-1980. doi: 10.1158/1078-0432.CCR-16-1790. Epub 2016 Oct 18.
Other Identifiers
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Degarelix Pre-Op
Identifier Type: -
Identifier Source: secondary_id
DEG_PRE-OP_001
Identifier Type: -
Identifier Source: org_study_id