A Degarelix Trial in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01242748
• Other study ID #: FE200486 CS35A
• Secondary ID: 2010-021434-55
• Status: Terminated
• Phase: Phase 3
• First received: November 16, 2010
• Last updated: May 13, 2015
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2015
• 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 Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

Description:

CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).

In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).

The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 288
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).

• Has completed the CS35 trial.

Exclusion Criteria:

• Has been withdrawn from the CS35 trial.

• Has had end of trial visit in CS35 prior to approval of the CS35A protocol.

Study Design

Allocation: Non-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. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
• Goserelin acetate
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.

Locations

Country	Name	City	State
Belgium	AZ Groeninge - Campus Sint-Maarten	Kortrijk
Canada	Jonathan Giddens Medicine Professional Corporation	Brampton	Ontario
Canada	Southern Interior Medical Research Inc.	Kelowna
Canada	Mor Urology, Inc.	Newmarket
Canada	Investigational site	Scarborough
Canada	Investigational site	Toronto
Czech Republic	Urocentrum Brno	Brno
Czech Republic	Nemocnice Jindrichuv Hradec, a.s.	Jindrichuv Hradec
Czech Republic	Kromerizska nemocnice a.s.	Kromeriz
Czech Republic	Fakultni nemocnice v Motole, Praha 5	Praha
Czech Republic	Vseobecna fakultni nemocnice v Praze, Praha 2	Praha
Czech Republic	Krajska nemocnice T. Bati a.s.	Zlin
Finland	ODL Terveys Oy	Oulu
Finland	Pohjois-Karjalan keskussairaala	Tampere
Finland	Tampereen yliopistollinen sairaala	Tampere
Germany	Gemeinschaftspraxis Rudolph & Wörner	Kirchheim
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 Nonprofit Kft.	Dombóvár
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, Chih.
Mexico	Hospital Angeles Culiacan	Culiacan, Sinaloa
Mexico	Consultorio de Especialidad en Urologia Privado	Durango
Mexico	Médica Sur, S.A.B. de C.V.	Mexico City
Mexico	Hospital Angeles Lindavista	Mexico City, DF
Mexico	Consultorio Medico	Zapopan, Jalisco
Netherlands	MC Haaglanden	Den Haag
Netherlands	Catharina-ziekenhuis	Eindhoven
Poland	SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego	Bialystok
Poland	Centrum Medyczne Medur Sp. z o.o.	Bielsko-Biala
Poland	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku	Slupsk
Romania	Private Medical Center SRL	Arad
Romania	Brasov Emergency Clinical County Hospital	Brasov
Romania	"Prof. Dr. Th. Burghele" Clinical Hospital	Bucharest
Romania	"Sfantul Ioan" Emergency Clinical Hospital	Bucharest
Romania	Dinu Uromedica	Bucharest
Romania	Fundeni Clinical Institute of Uronephrology and Renal Transplantation	Bucharest
Romania	PROVITA 2000 Medical Center	Constanta
Romania	"Dr. C.I. Parhon" Clinical Hospital	Iasi
Romania	Vita Care Flav Medical Center	Pitesti
Romania	Sibiu Emergency Clinical County Hospital	Sibiu
Ukraine	Dnipropetrovsk State Medical Academy	Dnipropetrovsk
Ukraine	Donetsk Regional Clinical Territorial Medical Association	Donetsk
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	Ipswich Hospital	Ipswich
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton
United States	Urology Group of New Mexico, PC	Albuquerque	New Mexico
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Seattle Urology Research Center	Burien	Washington
United States	The Urology Center of Colorado	Denver	Colorado
United States	Urology Associates of Dover, PA	Dover	Delaware
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology San Antonio Research, Pa	San Antonio	Texas

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,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin	PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.	From baseline to 3 years	No
Secondary	Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.	From baseline to 3 years	No
Secondary	Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.	From baseline to 3 years	No
Secondary	Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin	Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.	From baseline to 3 years	No
Secondary	Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin	Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.	From baseline to 3 years	No
Secondary	Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin	The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.	From baseline to 3 years	No
Secondary	Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin	Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.	Baseline and after 1, 6, 12, 19, and 22 months	No
Secondary	Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin	Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.	Baseline and after 1, 6, 12, 19, and 22 months	No