Clinical trial NCT00116753: A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
Official title: An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 460
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
timeFrame: From Day 28 to 12 or 13 months
Secondary outcomes:
measure: Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
timeFrame: From after Day 28 to 12 or 13 months
measure: Number of Participants With Testosterone <=0.5 ng/mL at Day 28
timeFrame: 28 Days
measure: Liver Function Tests
timeFrame: 12 or 13 months
measure: Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
timeFrame: 12 or 13 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliationed Research Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: La Mesa
country: United States
facility: Center for Urological Research
state: California
city: Laguna Woods,
country: United States
facility: South Orange County Medical Research Center
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Aurora
country: United States
facility: Urology Research Option
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Fort Myers
country: United States
facility: SW Florida Urological Associates
state: Florida
city: Ft Myers
country: United States
facility: RT Services, Inc
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Jackson
country: United States
facility: Mississippi Urology Clinic
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri, Urology, Deptof Surgery
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Urology Care
state: Missouri
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Fort Worth
country: United States
facility: Urology Association of Northern Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Seattle
country: United States
facility: Seatle Urology Research Centre
state: Washington
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Corp
state: British Columbia
city: Surrey
country: Canada
facility: Andreou Researce
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male/Female Health Centres and Research
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Hospital
state: Ontario
city: Oakville
country: Canada
facility: The Male/Female Health Centres and Research
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Center
state: Ontario
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Maria Hospital, Dept Urology
city: Joensuu
country: Finland
facility: Central Hospital, North Karelian, Dept. of Urology
city: Oys
country: Finland
facility: Oulu University Hospital, Department of Surgery Division of Urology
city: Tampere
country: Finland
facility: Tampere University Hospital, Dept. of Urology
city: Belgrade
country: Former Serbia and Montenegro
facility: Clinical Center of Serbia Institute of Urology and Nephrology
city: Novi Sad
country: Former Serbia and Montenegro
facility: Clinical Center Novi Sad, Clinic of Urology Hajduk
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie
city: Nice
country: France
facility: Fédération d'Urologie et Néphrologie
city: Aachen
country: Germany
facility: Gemeinschaftspraxis Dres Effert und Benedic
city: Berlin
country: Germany
facility: Klinik fuer Urologie, Vivantes Klinikum Am Urban
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, Urology
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Arad
country: Romania
facility: Centrul Medical Privat
city: Bucharest
country: Romania
facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
city: Bucharest
country: Romania
facility: University CF Hospital No.2, Urology Clinic
city: Saint Petersburg
country: Russian Federation
facility: Andros Clinic
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #15
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #26
city: Saint Petersburg
country: Russian Federation
facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
city: Saint Petersburg
country: Russian Federation
facility: Pavlov State Medical University, Urology Department
city: Falkirk
country: United Kingdom
facility: Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary
city: Middlesex
country: United Kingdom
facility: Mount Vernon Cancer Centre, Marie Curie Research Wing
city: North Humberside
country: United Kingdom
facility: Castle Hill Hospital, Dept. Urology
city: Plymouth
country: United Kingdom
facility: Level 7, Urology Research Unit, Derriford Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: