Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Key facts
- Study ID
- NCT01491971
- Run by
- Ferring Pharmaceuticals
- People needed
- 76
- Starts
- 2012-01-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2013-12-12
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
- 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:
- For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
- 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
- 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
You may not qualify if…
- Has had previous or is currently under hormonal management of prostate cancer
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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