A Degarelix Trial in Patients With Prostate Cancer

NCT01242748 | Terminated Phase 3 Results DMC

• 2 other identifiers: FE200486 CS35A2010-021434-55
• Study Type: interventional
• Target: 288
• Locations: 13 countries
• Sites: 63

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

  From baseline to 3 years

• Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

  From baseline to 3 years

• Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin

  From baseline to 3 years

• Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin

  From baseline to 3 years

• Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin

  From baseline to 3 years

Study Arms (2)

Degarelix 240 mg/480 mg

EXPERIMENTAL

Drug: Degarelix

Goserelin acetate

ACTIVE COMPARATOR

Drug: Goserelin acetate

Interventions

Degarelix 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.

Also known as: Firmagon, FE200486

Degarelix 240 mg/480 mg

Goserelin acetate 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.

Also known as: Zoladex

Goserelin acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has been withdrawn from the CS35 trial.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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (63)

University of Colorado School of Medicine

Aurora, Colorado, United States

Location

The Urology Center of Colorado

Denver, Colorado, United States

Location

Urology Associates of Dover, PA

Dover, Delaware, United States

Location

South Florida Medical Research

Aventura, Florida, United States

Location

Urology Group of New Mexico, PC

Albuquerque, New Mexico, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

Urology San Antonio Research, Pa

San Antonio, Texas, United States

Location

Seattle Urology Research Center

Burien, Washington, United States

Location

AZ Groeninge - Campus Sint-Maarten

Kortrijk, Belgium

Location

Jonathan Giddens Medicine Professional Corporation

Brampton, Ontario, Canada

Location

Southern Interior Medical Research Inc.

Kelowna, Canada

Location

Mor Urology, Inc.

Newmarket, Canada

Location

Investigational site

Scarborough, Canada

Location

Investigational site

Toronto, Canada

Location

Urocentrum Brno

Brno, Czechia

Location

Nemocnice Jindrichuv Hradec, a.s.

Jindřichův Hradec, Czechia

Location

Kromerizska nemocnice a.s.

Kroměříž, Czechia

Location

Fakultni nemocnice v Motole, Praha 5

Prague, Czechia

Location

Vseobecna fakultni nemocnice v Praze, Praha 2

Prague, Czechia

Location

Krajska nemocnice T. Bati a.s.

Zlín, Czechia

Location

ODL Terveys Oy

Oulu, Finland

Location

Pohjois-Karjalan keskussairaala

Tampere, Finland

Location

Tampereen yliopistollinen sairaala

Tampere, Finland

Location

Gemeinschaftspraxis Rudolph & Wörner

Kirchheim, Germany

Location

Urologische Studienpraxis

Nürtingen, Germany

Location

Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház

Budapest, Hungary

Location

Fövárosi Önkormányzat uzsoki utcai Kórház

Budapest, Hungary

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.

Dombóvár, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, Hungary

Location

Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft

Miskolc, Hungary

Location

Pécsi Tudományegyetem

Pécs, Hungary

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Hungary

Location

Jávorszky Ödön Kórház

Vác, Hungary

Location

Hospital Christus Muguerza del Parque

Chihuahua, Chih., Mexico

Location

Hospital Angeles Culiacan

Culiacan, Sinaloa, Mexico

Location

Consultorio de Especialidad en Urologia Privado

Durango, Mexico

Location

Médica Sur, S.A.B. de C.V.

Mexico City, Mexico

Location

Hospital Angeles Lindavista

Mexico City, DF, Mexico

Location

Consultorio Medico

Zapopan, Jalisco, Mexico

Location

Catharina-ziekenhuis

Eindhoven, Netherlands

Location

MC Haaglanden

The Hague, Netherlands

Location

SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego

Bialystok, Poland

Location

Centrum Medyczne Medur Sp. z o.o.

Bielsko-Biala, Poland

Location

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku

Słupsk, Poland

Location

Private Medical Center SRL

Arad, Romania

Location

Brasov Emergency Clinical County Hospital

Brasov, Romania

Location

"Prof. Dr. Th. Burghele" Clinical Hospital

Bucharest, Romania

Location

"Sfantul Ioan" Emergency Clinical Hospital

Bucharest, Romania

Location

Dinu Uromedica

Bucharest, Romania

Location

Fundeni Clinical Institute of Uronephrology and Renal Transplantation

Bucharest, Romania

Location

PROVITA 2000 Medical Center

Constanța, Romania

Location

"Dr. C.I. Parhon" Clinical Hospital

Iași, Romania

Location

Vita Care Flav Medical Center

Piteşti, Romania

Location

Sibiu Emergency Clinical County Hospital

Sibiu, Romania

Location

Dnipropetrovsk State Medical Academy

Dnipropetrovsk, Ukraine

Location

Donetsk Regional Clinical Territorial Medical Association

Donetsk, Ukraine

Location

Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval

Kharkiv, Ukraine

Location

Kyiv City Clinical Hospital #3

Kyiv, Ukraine

Location

Odesa Regional Clinical Hospital

Odesa, Ukraine

Location

Municipal Institution "Zaporizhzhia Regional Clinical Hospital"

Zaporizhzhya, Ukraine

Location

Ipswich Hospital

Ipswich, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 3, 2015
• Results First Posted: June 3, 2015

Record last verified: 2015-05

Locations

HU (9); ME (6); US (8); CA (5); PL (3); DE (2); BE (1); FI (3); GB (2); RO (10); CZ (6); UA (6); NL (2)