A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116753
• Other study ID #: FE200486 CS15
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: November 12, 2010
• Start date: January 2005
• Est. completion date: November 2006

Study information

• Verified date: November 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
• Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
• Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg Leuven	Leuven
Canada	The Male/Female Health Centres and Research	Barrie	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	Southern Interior Medical Research Corp	Kelowna	British Columbia
Canada	North Bay Hospital	North Bay	Ontario
Canada	The Male/Female Health Centres and Research	Oakville	Ontario
Canada	Andreou Researce	Surrey	British Columbia
Canada	The Male Health Center	Toronto	Ontario
Canada	Can-Med Clinical Research Inc.	Victoria	British Columbia
Finland	Helsinki University Hospital, Maria Hospital, Dept Urology	Helsinki
Finland	Central Hospital, North Karelian, Dept. of Urology	Joensuu
Finland	Oulu University Hospital, Department of Surgery Division of Urology	Oys
Finland	Tampere University Hospital, Dept. of Urology	Tampere
Former Serbia and Montenegro	Clinical Center of Serbia Institute of Urology and Nephrology	Belgrade
Former Serbia and Montenegro	Clinical Center Novi Sad, Clinic of Urology Hajduk	Novi Sad
France	Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie	La Roche-sur-Yon
France	Fédération d'Urologie et Néphrologie	Nice
Germany	Gemeinschaftspraxis Dres Effert und Benedic	Aachen
Germany	Klinik fuer Urologie, Vivantes Klinikum Am Urban	Berlin
Netherlands	Academic Medical Center, Urology	Amsterdam
Netherlands	St. Elisabeth Hospital	Tilburg
Romania	Centrul Medical Privat	Arad
Romania	Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department	Bucharest
Romania	University CF Hospital No.2, Urology Clinic	Bucharest
Russian Federation	Andros Clinic	Saint Petersburg
Russian Federation	City Hospital #15	Saint Petersburg
Russian Federation	City Hospital #26	Saint Petersburg
Russian Federation	Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department	Saint Petersburg
Russian Federation	Pavlov State Medical University, Urology Department	Saint Petersburg
United Kingdom	Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary	Falkirk
United Kingdom	Mount Vernon Cancer Centre, Marie Curie Research Wing	Middlesex
United Kingdom	Castle Hill Hospital, Dept. Urology	North Humberside
United Kingdom	Level 7, Urology Research Unit, Derriford Hospital	Plymouth
United States	Advanced Urology Medical Center	Anaheim	California
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	Urology Research Option	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	University of Missouri, Urology, Deptof Surgery	Columbia	Missouri
United States	Northeast Urology Research	Concord	North Carolina
United States	SW Florida Urological Associates	Fort Myers	Florida
United States	Urology Association of Northern Texas	Fort Worth	Texas
United States	RT Services, Inc	Ft Myers	Florida
United States	The Urology Center	Greensboro	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Medical Affiliationed Research Center	Huntsville	Alabama
United States	Mississippi Urology Clinic	Jackson	Mississippi
United States	Kansas City Urology Care	Kansas City	Missouri
United States	Center for Urological Research	La Mesa	California
United States	South Orange County Medical Research Center	Laguna Woods,	California
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Urology San Antonio Research	San Antonio	Texas
United States	Seatle Urology Research Centre	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	State College Urologic Association	State College	Pennsylvania
United States	West Coast Clinical Research	Tarzana	California
United States	Western Clinical Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  Former Serbia and Montenegro,  France,  Germany,  Netherlands,  Romania,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study	Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.	From Day 28 to 12 or 13 months	No
Secondary	Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study	Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.	From after Day 28 to 12 or 13 months	No
Secondary	Number of Participants With Testosterone <=0.5 ng/mL at Day 28	Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.	28 Days	No
Secondary	Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	12 or 13 months	No
Secondary	Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	12 or 13 months	No