A Trial of Degarelix in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946920
• Other study ID #: FE200486 CS35
• Secondary ID: 2008-005276-27
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2009
• Last updated: May 2, 2014
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaMexico: Ministry of HealthBelgium: Federal Agency for Medicines and Health Products, FAMHPFinland: Finnish Medicines AgencyGermany: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportUnited Kingdom: National Health ServiceCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Ministry of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older.

• Has a histological confirmed prostate cancer Gleason graded).

• Has a screening testosterone above 2.2 ng/mL.

• Rising prostate-specific antigen (PSA).

• Has Eastern Cooperative Oncology Group (ECOG) score of = 2.

• Has a life expectancy of at least one year.

Exclusion Criteria:

• Current or previous hormone therapy.

• Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.

• Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

• Has a heart insufficiency.

• Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.

• Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.

• Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.

• Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

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
The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
• Goserelin acetate
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge - Campus Sint-Maarten	Kortrijk
Canada	Bramalea Medical Centre	Brampton	Ontario
Canada	Southern Interior Medical Research Inc.	Kelowna	British Columbia
Canada	Urology Associates / Urologic Medical Research	Kitchener	Ontario
Canada	Uro Laval	Laval	Quebec
Canada	Notre Dame Hopital	Montreal
Canada	Mor Urology, Inc.	Newmarket	Ontario
Canada	Ivestigational site	Scarborough	Ontario
Canada	Dr. Cal Andreou Research	Surrey	British Columbia
Canada	Anthony Skehan Medicine Professionals Corporation	Thunder Bay	Ontario
Canada	Bloor West Professional Center	Toronto	Ontario
Canada	The Health Institute for Men	Toronto	Ontario
Canada	Can-Med Clinical Research Inc.	Victoria	British Columbia
Canada	Dr Gary Steinhoff Clinical Research	Victoria	British Columbia
Czech Republic	Urocentrum Brno	Brno
Czech Republic	Nemocnice Jindrichuv Hradec, a.s.	Jindrichuv Hradec
Czech Republic	Kromerizska nemocnice a.s.	Kromeriz
Czech Republic	Slezska nemocnice	Opava
Czech Republic	Fakultni nemocnice v Motole, Praha 5	Prague
Czech Republic	Fakultni Thomayerova nemocnice s poliklinikou, Praha 4	Prague
Czech Republic	Vseobecna fakultni nemocnice v Praze, Praha 2	Prague
Czech Republic	Krajska nemocnice T. Bati a.s.	Zlin
Finland	Pohjois-Karjalan keskussairaala	Joensuu
Finland	ODL Terveys Oy	Oulu
Finland	Pietarsaaren sairaala/ Malmin terveydenhuoltoalue	Pietarsaari
Finland	Tampereen yliopistollinen sairaala	Tampere
Germany	Investigational site	Aachen
Germany	Investigational site	Kirchheim
Germany	Klinikum Mannheim Universitätsklinikum GmbH	Mannheim
Germany	Urologische Studienpraxis	Nürtingen
Hungary	Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház	Budapest
Hungary	Fövárosi Önkormányzat uzsoki utcai Kórház	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Dombóvári Szent Lukács Egészségügyi Kht.	Dombovar
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	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged
Hungary	Jávorszky Ödön Kórház	Vác
Mexico	Hospital Christus Muguerza del Parque	Chihuahua
Mexico	Hospital Angeles Culiacan	Culiacan	Sinaloa
Mexico	Consultorio de Especialidad en Urologia Privado, Durango	Durango
Mexico	Hospital Aranda de la Parra , S.A. de C.V.	Leon	GTO
Mexico	Centro Medico Dalinde	Mexico City
Mexico	Hospital Angeles Lindavista	Mexico City
Mexico	Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)	Mexico City
Mexico	Consultorio Medico	Zapopan, Jalisco
Netherlands	AMC	Amsterdam
Netherlands	MC Haaglanden	Den Haag
Netherlands	Catharina-ziekenhuis	Eindhoven
Netherlands	Atrium MC	Heerlen
Poland	SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego	Bialystok
Poland	Centrum Medyczne Medur Sp. z o.o.	Bielsko-Biala
Poland	Gabinet Lekarski	Krakow
Poland	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku	Slupsk
Poland	LexMedica	Wroclaw
Romania	Private Medical Center	Arad
Romania	Brasov Emergency Clinical County Hospital	Brasov
Romania	"Fundeni" Clinical Institute	Bucharest
Romania	"Sfantul Ioan" Emergency Clinical Hospital	Bucharest
Romania	Dinu Uromedica	Bucharest
Romania	Prof. Dr. Th. Burghele Clinical Urology Hospital	Bucharest
Romania	PROVITA 2000 Medical Center	Constanta
Romania	"Dr. C.I. Parhon" Clinical Hospital	Lasi
Romania	Vita Care Flav Medical Center	Pitesti
Romania	Emergency County Clinical Hospital Sibiu	Sibiu
Russian Federation	City Clinical Hospital #60	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow
Russian Federation	"Clinic Andros" LLC	St. Petersburg
Russian Federation	"Orkli" LLC	St. Petersburg
Russian Federation	City Hospital # 26	St. Petersburg
Russian Federation	City Hospital #15	St. Petersburg
Russian Federation	St. Petersburg State Medical University n.a. I.P. Pavlov	St. Petersburg
Russian Federation	St.Petersburg Multi-Field City Hospital #2	St. Petersburg
Russian Federation	Regional Clinical Oncology Center	Vladimir
Ukraine	Municipal Institution "Cherkasy Regional Oncology Dispensary"	Cherkassy
Ukraine	Dnipropetrovsk State Medical Academy	Dnipropetrovsk
Ukraine	Donetsk Regional Clinical Territorial Medical Association	Donetsk
Ukraine	Ivano-Frankivsk Regional Oncology Dispensary	Ivano-Frankivsk
Ukraine	Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval	Kharkiv
Ukraine	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	Municipal Institution "Zaporizhzhia Regional Clinical Hospital"	Zaporizhzhya
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton
United States	Capital Region Urological Surgeons and Research Associates	Albany	New York
United States	Urology Group of New Mexico, PC	Albuquerque	New Mexico
United States	Anschutz Cancer Pavillion	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of SEPA	Bala Cynwyd	Pennsylvania
United States	Seattle Urology Research Center	Burien	Washington
United States	Metrolina Urology Clinic	Charlotte	North Carolina
United States	Northeast Urology Research	Concord	North Carolina
United States	Urology Clinics of North Texas, PA	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Urology Associates of Dover, PA	Dover	Delaware
United States	Duke University Medical Center	Durham	North Carolina
United States	Urological Associates of Englewood	Englewood	New Jersey
United States	Urology Associates of Central CA	Fresno	California
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Hamilton Urology PA	Hamilton	New Jersey
United States	Urology Centers Of Alabama	Homewood	Alabama
United States	Indiana University Department of Urology	Indianapolis	Indiana
United States	Medresearch	La Mesa	California
United States	South Orange County Medical Research Center	Laguna Hills	California
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Arkansas Urology	Little Rock	Arkansas
United States	Atlantic Urology Medical Group	Long Beach	California
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Urology of Virginia	Norfolk	Virginia
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	Kansas City Urology Care, PA	Overland Park	Kansas
United States	Hudson Valley Urology P.C.	Poughkeepsie	New York
United States	Virginia Urology Center	Richmond	Virginia
United States	Urology San Antonio Research	San Antonio	Texas
United States	State College Urologic Association	State College	Pennsylvania
United States	Urological Associates of Bridgeport, P.C.	Trumbull	Connecticut
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Georgis Patsias, MD, PA	Wellington	Florida
United States	Palm Beach Urology Associates, PA	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Finland,  Germany,  Hungary,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL) With Degarelix	This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression =0.5 ng/mL from Day 28 to Day 364.	From Day 28 to Day 364	No
Primary	Difference in Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL) Between Degarelix and Goserelin	This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.	Day 3 to Day 364	No
Secondary	Serum Levels of Testosterone Over Time	Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.	Baseline and after 1, 2, 3, 6 and 13 months	No
Secondary	Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time	Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.	Baseline and after 1, 2, 3, 6 and 13 months	No
Secondary	Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline	The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.	At baseline, 10 months and 13 months	No
Secondary	Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline	IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.	At baseline, 1 month, 4 months, 7 months and 13 months	No