Clinical trial NCT00451958: A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Official title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Degarelix
prostate cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-26
Enrollment: 386
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: Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.


Eligibility criteria: Inclusion/Exclusion Criteria:

* Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Signed informed consent
* The patients must have completed the FE 200486 CS21 Study.

Primary outcomes:
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Up to 4 years of treatment
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: Up to 4 years of treatment
Secondary outcomes:
measure: Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
timeFrame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
measure: Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
timeFrame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
measure: Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
timeFrame: From time of switch to Day 56
measure: Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
timeFrame: From time of switch to Day 56
measure: Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
timeFrame: From time of switch to Day 56
measure: Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
timeFrame: From time of switch to Day 56
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Englewood
country: United States
facility: Urology Associates Research
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Investigational Site
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Carmel
country: United States
facility: Investigational Site
state: New York
city: Concord
country: United States
facility: North Urology Research
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Kentville
country: Canada
facility: Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: The Female/Male Health Centres
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Burlington
country: Canada
facility: Burlington Professional Centre
state: Ontario
city: Burlington
country: Canada
facility: The Urology Research Centre
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: The Female/Male Health Centres
state: Ontario
city: Greenfields
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc
city: Brno
country: Czech Republic
facility: Urocentrum Brno
city: Brno
country: Czech Republic
facility: UROHELP - Bozetechova
city: Jindrichuv Hradec
country: Czech Republic
facility: Nemocnice Jindrichuv Hradec, a.s.
city: Olomouc
country: Czech Republic
facility: Fakultni Nemocnice Olomouc
city: Opava
country: Czech Republic
facility: Slezska nemocnice
city: Prague
country: Czech Republic
facility: Fakultni nemocnice v Motole, Prague5
city: Prague
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze, Prague2
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitätsklinikum GmbH
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat uzsoki utcai Kórház
city: Dombóvár
country: Hungary
facility: Dombóvári Szent Lukács Egészségügyi Kht.
city: Györ
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Szeged
country: Hungary
facility: Investigational Site
city: Acapulco
country: Mexico
facility: Investigational Site
city: Chihuahua, Chih.
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Durango
country: Mexico
facility: Investigational Sit
city: Leon, GTO
country: Mexico
facility: Hospital Aranda de la Parra , S.A. de C.V.
city: Mexico, DF
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
city: Mexico, DF
country: Mexico
facility: Investigational Site
city: Zapopan, Jalisco
country: Mexico
facility: Consultorio Medico
city: Zapopan, Jalisco
country: Mexico
facility: Investigational Site
city: Ede
country: Netherlands
facility: Investigational Site
city: Eindhoven
country: Netherlands
facility: Investigational Site
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Ponce
country: Puerto Rico
facility: Hospital Andres Grillasca
city: Arad
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Fundeni Uronephrology and Renal Transplant Clinical Institute
city: Bucharest
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Sfantul Ioan" Emergency Clinical Hospital
city: Constanta
country: Romania
facility: PROVITA 2000 Medical Center
city: Iasi
country: Romania
facility: Investigational Site
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #1 n.a. N.I.Pirogov
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #60
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
city: St. Petersburg
country: Russian Federation
facility: City Pokrovskaya Hospital
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Medical Academy n. a. I.I.Mechnikov
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk State Medical Academy
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Odesa
country: Ukraine
facility: Odesa State Medical University
city: Bebington, Wirral
country: United Kingdom
facility: Clatterbridge Centre For Oncology
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.