A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451958
• Other study ID #: FE200486 CS21A
• Secondary ID: 2006-006913-34
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2007
• Last updated: March 20, 2013
• Start date: March 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

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 80 mg / Degarelix 80 mg

• Degarelix 160 mg / Degarelix 160 mg

• Leuprolide 7.5 mg / Degarelix 80 mg

• Leuprolide 7.5 mg / Degarelix 160 mg

Locations

Country	Name	City	State
Canada	The Female/Male Health Centres	Barrie	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	Burlington Professional Centre	Burlington	Ontario
Canada	The Urology Research Centre	Burlington	Ontario
Canada	Urology South Shore Research	Greenfields	Quebec
Canada	Investigational Site	Kentville	Nova Scotia
Canada	Investigational Site	Newmarket	Ontario
Canada	The Female/Male Health Centres	Oakville	Ontario
Canada	Can-Med Clinical Research Inc	Victoria
Czech Republic	Urocentrum Brno	Brno
Czech Republic	UROHELP - Bozetechova	Brno
Czech Republic	Nemocnice Jindrichuv Hradec, a.s.	Jindrichuv Hradec
Czech Republic	Fakultni Nemocnice Olomouc	Olomouc
Czech Republic	Slezska nemocnice	Opava
Czech Republic	Fakultni nemocnice v Motole, Prague5	Prague
Czech Republic	Vseobecna fakultni nemocnice v Praze, Prague2	Prague
Germany	Klinikum Mannheim Universitätsklinikum GmbH	Mannheim
Germany	Klinikum der Universität Regensburg	Regensburg
Hungary	Fövárosi Önkormányzat uzsoki utcai Kórház	Budapest
Hungary	Dombóvári Szent Lukács Egészségügyi Kht.	Dombóvár
Hungary	Petz Aladár Megyei Oktató Kórház	Györ
Hungary	Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft	Miskolc
Hungary	Pécsi Tudományegyetem	Pécs
Hungary	Investigational Site	Szeged
Mexico	Investigational Site	Acapulco
Mexico	Hospital Christus Muguerza del Parque	Chihuahua, Chih.
Mexico	Investigational Sit	Durango
Mexico	Hospital Aranda de la Parra , S.A. de C.V.	Leon, GTO
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico	Mexico, DF
Mexico	Investigational Site	Mexico, DF
Mexico	Consultorio Medico	Zapopan, Jalisco
Mexico	Investigational Site	Zapopan, Jalisco
Netherlands	Investigational Site	Ede
Netherlands	Investigational Site	Eindhoven
Netherlands	Atrium MC	Heerlen
Puerto Rico	Hospital Andres Grillasca	Ponce
Romania	Investigational Site	Arad
Romania	Fundeni Uronephrology and Renal Transplant Clinical Institute	Bucharest
Romania	Investigational Site	Bucharest
Romania	Sfantul Ioan" Emergency Clinical Hospital	Bucharest
Romania	PROVITA 2000 Medical Center	Constanta
Romania	Investigational Site	Iasi
Romania	Sibiu Emergency Clinical County Hospital	Sibiu
Russian Federation	City Clinical Hospital #1 n.a. N.I.Pirogov	Moscow
Russian Federation	City Clinical Hospital #60	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow
Russian Federation	City Pokrovskaya Hospital	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	St.Petersburg State Medical Academy n. a. I.I.Mechnikov	St. Petersburg
Ukraine	Dnipropetrovsk State Medical Academy	Dnipropetrovsk
Ukraine	Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval	Kharkiv
Ukraine	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	Odesa State Medical University	Odesa
United Kingdom	Clatterbridge Centre For Oncology	Bebington, Wirral
United States	South Florida Medical Research	Aventura	Florida
United States	Seattle Urology Research Center	Burien	Washington
United States	Investigational Site	Carmel	New York
United States	North Urology Research	Concord	North Carolina
United States	Urology Associates Research	Englewood	Colorado
United States	Investigational Site	Greensboro	North Carolina
United States	Urology Centers Of Alabama	Homewood	Alabama
United States	South Orange County Medical Research Center	Laguna Hills	California
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Investigational Site	Ocala	Florida
United States	Urology San Antonio Research	San Antonio	Texas
United States	Regional Urology	Shreveport	Louisiana
United States	State College Urologic Association	State College	Pennsylvania
United States	Western Clinical Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  Mexico,  Netherlands,  Puerto Rico,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	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 (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.	Up to 4 years of treatment	No
Primary	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.	Up to 4 years of treatment	No
Secondary	Percentage of Participants With no Prostate-specific Antigen (PSA) Progression	PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).	Until all participants have received at least 5 years of treatment and at a frequency of every 3 months	No
Secondary	Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards	The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.; In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.	Until all participants have received at least 5 years of treatment and at a frequency of every 6 months	No
Secondary	Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56		From time of switch to Day 56	No
Secondary	Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56		From time of switch to Day 56	No
Secondary	Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56		From time of switch to Day 56	No
Secondary	Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56		From time of switch to Day 56	No