Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00801242

Purpose

The purpose of this trial is to see how well a new trial drug (degarelix) works and how safe it is when given for 7 months. For patients participating, their level of PSA (prostate specific antigen) will be measured in a blood sample, and when this level rises above a certain level they will receive treatment for the prostate cancer again. The patients will come to the clinic at monthly intervals for the first 7 months and after this they will be followed bi-monthly for a period of up to 24 months.

Condition	Intervention	Phase
Prostate Cancer	Drug: degarelix	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
degarelix: Experimental	Drug: degarelix One starting dose of 240 mg; followed by monthly maintenance doses of 80 mg for 7 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has given written informed consent before any trial-related activity is performed.
Has prostate cancer, and is in need of this type of treatment.

Exclusion Criteria:

Has had previous or is currently under hormonal treatment of prostate cancer.
Is considered to be candidate for radical prostatectomy or radiotherapy.
Has a history of severe uncontrolled asthma and/or other severe allergic reactions.
Has hypersensitivity towards any component of degarelix.
Has had cancer within the last five years except prostate cancer and some types of skin cancer.
Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801242

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Hide Study Locations

Locations

Belgium
Hospital St Jan Brugge	Recruiting
Brugge, Belgium, 8000
Erasme Hospital, University Clinics of Brussels	Recruiting
Brussels, Belgium, 1070
University Hospîtal St-Luc	Recruiting
Brussels, Belgium, 1200
University Hospitals Leuven	Recruiting
Leuven, Belgium, 3000
France
Hôpital Henri Mondor	Recruiting
CRETEIL, France, 94 000
CHU Hôpital Sud	Withdrawn
AMIENS cedex 1, France, 80 054
CHU Hôtel-Dieu	Recruiting
NANTES cedex 1, France, 44 093
Centre Hospitalier René Dubos	Recruiting
CERGY PONTOISE cedex, France, 95 303
Hôpital Gabriel Montpied	Recruiting
CLERMONT-FERRAND cedex 1, France, 63 003
Hôpital Claude Huriez	Recruiting
LILLE cedex, France, 59 037
Hôpital de la Conception	Recruiting
MARSEILLE cedex 05, France, 13 385
Clinique Beausoleil	Recruiting
MONTPELLIER, France, 34 070
Hôpital Pellegrin	Recruiting
BORDEAUX cedex, France, 33 076
Hôpital Pasteur	Recruiting
NICE cedex 1, France, 06 002
CHU Bichat	Recruiting
PARIS, France, 75 018
Hôpital Saint Louis	Recruiting
PARIS, France, 75 010
CHU Pitié Salpétrière	Recruiting
PARIS, France, 75 013
Centre Hospitalier Lyon Sud	Recruiting
PIERRE BENITE, France, 69 310
Hôpital Tenon	Recruiting
PARIS cedex 20, France, 75 970
Hôpital Cochin	Recruiting
PARIS cedex 14, France, 75 679
CHU Le Milétrie	Recruiting
POITIERS, France, 86 000
Hôpital Pontchaillou	Recruiting
RENNES cedex, France, 35 033
Hôpitaux Universitaires de Strasbourg	Recruiting
STRASBOURG cedex, France, 67 091
Hôpital de Rangueil	Recruiting
TOULOUSE cedex 9, France, 31 059
Germany
Universitätsklinikum Düsseldorf	Recruiting
Düsseldorf, Germany, 40255
Gemeinschaftspraxis Dres. Böhle, Rohde	Recruiting
Bad Schwartau, Germany, 23611
Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst	Recruiting
Erkrath, Germany, 40699
Urologische Gemeinschaftspraxis	Recruiting
Kempen, Germany, 47906
Gemeinschaftspraxis Dres. Rudolph, Wörner	Recruiting
Kirchheim, Germany, 73230
Facharzt für Urologie	Recruiting
Rosenheim, Germany, 83022
Praxisgemeinschaft f. Onkologie & Urologie	Recruiting
Wilhelmshaven, Germany, 26389
Facharzt für Urologie	Recruiting
Wertingen, Germany, 86637
Eberhard-Kars-Universität Tübingen	Recruiting
Tübingen, Germany, 72076
Praxis für Urologie	Recruiting
Zwickau, Germany, 08060
Italy
Azienda Ospedaliera S. Giuseppe Moscati	Recruiting
Avellino, Italy, 83100
Università degli Studi di Firenze	Recruiting
Bagno a Ripoli (FI), Italy, 50011
Azienda Policlinico Universitario G. Martino	Recruiting
Messina, Italy, 98122
Ospedale S. Raffaele	Recruiting
Milano, Italy, 20132
Università degli Studi di Padova	Not yet recruiting
Padova, Italy, 35128
Policlinico Univ. Agostino Gemelli	Recruiting
Roma, Italy, 00168
Netherlands
Twenteborg Ziekenhuis	Recruiting
Almelo, Netherlands, 7609 PP
Universitair Medisch Centrum Groningen	Recruiting
Groningen, Netherlands, 9713 GZ
Atrium MC Kerkrade	Recruiting
Kerkrade, Netherlands, 6461 AL
Maatschap Urologie-Diaconessenhuis Leiden	Recruiting
Leiden, Netherlands, 2334 CK
UMC St.Radboud	Recruiting
Nijmegen, Netherlands, 6525 GA
Spain
Complexo Hospitalario Universitario A Coruña (CHUAC)	Recruiting
A Coruña, Spain, 15006
Instituto Valenciano de Oncologia	Recruiting
Valencia, Spain, 46009
Hospital Universitario Vall d'Hebron	Recruiting
Barcelona, Spain, 08035
Hospital Virgen de las Nieves	Recruiting
Granada, Spain, 18014
Hospital Universitario 12 de Octubre	Recruiting
Madrid, Spain, 28041
Corporacio Sanitaria Parc Tauli	Recruiting
Sabadell, Spain, 08208
Hospital Universitario Principe de Asturias	Recruiting
Alcalá de Henares, Madrid, Spain, 28805

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS29, EudraCT No: 2008-003931-19
Study First Received:	December 2, 2008
Last Updated:	September 7, 2009
ClinicalTrials.gov Identifier:	NCT00801242 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: National Consultative Ethics Committee for Health and Life Sciences; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica; Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009