Status:
COMPLETED
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01491971
Start Date
January 1 2012
End Date
November 1 2012
Last Update
December 12 2013
Active Locations (15)
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1
Urology Centers of Alabama
Homewood, Alabama, United States
2
South Orange County Urology Research
Laguna Hills, California, United States
3
San Bernadino Urological Association
San Bernadino, California, United States
4
South Florida Medical Research
Aventura, Florida, United States