Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
NCT ID: NCT01491971
Last Updated: 2013-12-12
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
76 participants
INTERVENTIONAL
2012-01-31
2012-11-30
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 - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Degarelix
Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Degarelix
Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Degarelix
Interventions
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Degarelix
Eligibility Criteria
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Inclusion Criteria
* Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
* Has a PSA level meeting one of these criteria:
1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir
* Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as \>150 ng/dL
* Has an Eastern Cooperative Oncology Group score of ≤2
* Has a life expectancy of at least one year
Exclusion Criteria
* Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
* Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
* Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms)
* Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
* Has a previous history or presence of another malignancy, other than prostate
* Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
* Has received 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
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
South Orange County Urology Research
Laguna Hills, California, United States
San Bernadino Urological Association
San Bernadino, California, United States
South Florida Medical Research
Aventura, Florida, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Carolina Clinical Trials
Concord, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Clinic of North Texas
Dallas, Texas, United States
Urology San Antonio Research, Pa
San Antonio, Texas, United States
Pacific Urologic Research
Victoria, British Columbia, Canada
Euroscope Inc
Barrie, Ontario, Canada
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, Canada
Office of Dr. Bernard Goldfarb
North Bay, Ontario, Canada
Urology South Shore Research
Greenfield Park, Quebec, Canada
Countries
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Other Identifiers
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000008
Identifier Type: -
Identifier Source: org_study_id