A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
Key facts
- Study ID
- NCT00116753
- Run by
- Ferring Pharmaceuticals
- People needed
- 460
- Starts
- 2005-01-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2010-12-10
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.
- Is a male patient aged 18 years or over.
- Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
- Has a PSA value of 2 ng/mL.
- Has a life expectancy of at least 13 months.
You may not qualify if…
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
- Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
- Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- Has a known or suspected hepatic or symptomatic biliary disease.
- Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit.
- Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results.
- Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator.
- Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
- Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study.
- Has previously participated in any degarelix study.
Where it is running
- Medical Affiliationed Research Center — Huntsville, Alabama, United States
- Alaska Clinical Research Center, LLC — Anchorage, Alaska, United States
- Advanced Urology Medical Center — Anaheim, California, United States
- Center for Urological Research — La Mesa, California, United States
- South Orange County Medical Research Center — Laguna Woods, California, United States
- West Coast Clinical Research — Tarzana, California, United States
- Western Clinical Research — Torrance, California, United States
- Urology Research Option — Aurora, Colorado, United States
- South Florida Medical Research — Aventura, Florida, United States
- RT Services, Inc — Fort Myers, Florida, United States
- SW Florida Urological Associates — Fort Myers, Florida, United States
- Regional Urology — Shreveport, Louisiana, United States
- Mississippi Urology Clinic — Jackson, Mississippi, United States
- University of Missouri, Urology, Deptof Surgery — Columbia, Missouri, United States
- Kansas City Urology Care — Kansas City, Missouri, United States
- Northeast Urology Research — Concord, North Carolina, United States
- The Urology Center — Greensboro, North Carolina, United States
- State College Urologic Association — State College, Pennsylvania, United States
- Grand Strand Urology — Myrtle Beach, South Carolina, United States
- Urology Association of Northern Texas — Fort Worth, Texas, United States
- Urology San Antonio Research — San Antonio, Texas, United States
- Seatle Urology Research Centre — Seattle, Washington, United States
- UZ Gasthuisberg Leuven — Leuven, Belgium
- Southern Interior Medical Research Corp — Kelowna, British Columbia, Canada
- Urology Centers of Alabama — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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