A Degarelix Trial in Patients With Prostate Cancer

NCT ID: NCT01242748

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-01-31

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 240 mg/480 mg

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Goserelin acetate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Firmagon; FE200486; Zoladex

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

University of Colorado School of Medicine

Aurora, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Urology Associates of Dover, PA

Dover, Delaware, United States

South Florida Medical Research

Aventura, Florida, United States

Urology Group of New Mexico, PC

Albuquerque, New Mexico, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology San Antonio Research, Pa

San Antonio, Texas, United States

Seattle Urology Research Center

Burien, Washington, United States

AZ Groeninge - Campus Sint-Maarten

Kortrijk, , Belgium

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, , Canada

Urocentrum Brno

Brno, , Czechia

Nemocnice Jindrichuv Hradec, a.s.

Jindřichův Hradec, , Czechia

Kromerizska nemocnice a.s.

Kroměříž, , Czechia

Fakultni nemocnice v Motole, Praha 5

Prague, , Czechia

Vseobecna fakultni nemocnice v Praze, Praha 2

Prague, , Czechia

Krajska nemocnice T. Bati a.s.

Zlín, , Czechia

ODL Terveys Oy

Oulu, , Finland

Pohjois-Karjalan keskussairaala

Tampere, , Finland

Tampereen yliopistollinen sairaala

Tampere, , Finland

Gemeinschaftspraxis Rudolph & Wörner

Kirchheim, , Germany

Urologische Studienpraxis

Nürtingen, , Germany

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, , Hungary

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, , Mexico

Catharina-ziekenhuis

Eindhoven, , Netherlands

MC Haaglanden

The Hague, , Netherlands

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

Słupsk, , Poland

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

Constanța, , Romania

"Dr. C.I. Parhon" Clinical Hospital

Iași, , Romania

Vita Care Flav Medical Center

Piteşti, , Romania

Sibiu Emergency Clinical County Hospital

Sibiu, , Romania

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, , Ukraine

Ipswich Hospital

Ipswich, , United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United States; Belgium; Canada; Czechia; Finland; Germany; Hungary; Mexico; Netherlands; Poland; Romania; Ukraine; United Kingdom

Other Identifiers

2010-021434-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FE200486 CS35A

Identifier Type: -

Identifier Source: org_study_id