Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00831233

Purpose

The purpose of this trial is to see how well a new trial drug (Degarelix) works on symptoms in the lower urinary tract in prostate cancer patients as compared to how a standard drug hormonal treatment works on the same symptoms. The lower urinary tract symptoms (also known as LUTS) are associated with the advancement/worsening of prostate cancer, and the symptoms impact the ability to urinate normally and thereby the quality of life for these patients. Patients will be randomly selected (like flipping a coin) to receive either Degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms will be evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix Drug: Goserelin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After treatment of 4 and 8 weeks compared to Baseline ] [ Designated as safety issue: No ]
LUTS relief based on maximum urine flow (Qmax) and residual volume (Vresidual) [ Time Frame: After treatment of 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Prostate size reduction based on Trans Rectal Ultra Sound (TRUS) [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
Time to removal of urethral catheter [ Time Frame: As applicable ] [ Designated as safety issue: No ]
Change in Testosterone serum concentration [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Change in PSA concentration [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Quality of Life evaluation based on questionnaire [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Safety (Adverse events and lab values) [ Time Frame: As applicable ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug: Degarelix	Drug: Degarelix
2: Active Comparator Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®)	Drug: Goserelin

Eligibility

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

Criteria

Inclusion Criteria:

Patient has given written informed consent before any trial-related activity is performed
Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

Previous treatment for prostate cancer
Previous trans-urethral resection of the prostate
Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Hypersensitivity towards any component of the investigational product
Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831233

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Locations

Germany
Gemeinschaftspraxis	Recruiting
Borken, Germany, 46325
Urologische Klinik Planegg	Recruiting
Planegg, Germany, 82152
VITURO Gesellschaft für Klinische Studien	Recruiting
Leipzig, Germany, 04109
Facharztpraxis für Urologie	Recruiting
Bamberg, Germany, 96047
Urologische Gemeinschaftspraxis	Recruiting
Hamburg, Germany, 22399
Euromed Clinic	Recruiting
Fürth, Germany, 90763
Universitätsklinikum Dresden	Recruiting
Dresden, Germany, 01307
Klinikum Offenbach GmbH	Recruiting
Offenbach, Germany, 63069
Gemeinschaftspraxis	Recruiting
Köln, Germany, 50667
Wuppertaler Gemeinschaftspraxis	Recruiting
Wuppertal, Germany, 42103
Spain
Hospital Manacor	Recruiting
Manacor, Spain, 07500
Hospital universitario Ramón y Cajal	Recruiting
Madrid, Spain, 28034
Hospital Santiago de Compostela	Recruiting
Santiago de Compostela, Spain, 15706
Hospital Universitario Central de Asturias	Recruiting
Oviedo, Spain, 33006
Fundacion Hospital Alcorcón	Recruiting
Alcorcon, Spain, 28922
Hospital Universitario Puerta de Hierro	Recruiting
Majadahonda, Madrid, Spain, 28222
Hospital Xeral de Vigo	Recruiting
Vigo, Spain, 36204
Hospital Clinico Universitario S. Carlos	Recruiting
Madrid, Spain, 28040
Hospital Universitario Principe de Asturias	Recruiting
Alcalá de Henares-Madrid, Spain, 28805
Hospital Virgen Macarena	Recruiting
Sevilla, Spain, 41014
Complejo Hospitalario Universitario A Coruña	Recruiting
Coruña, Spain
Hospital de Basurto	Recruiting
Bilbao (Bizkaia), Spain, 48013
Fundación Puigvert	Recruiting
Barcelona, Spain, 08025
United Kingdom
Royal Hallamshire Hospital, Sheffield South	Recruiting
Sheffield, United Kingdom, S10 2JF
United Bristol Healthcare NHSTrust Bristol Royal Infirmary	Recruiting
Bristol, United Kingdom, BS2 8HW
Sunderland Royal Hospital	Recruiting
Sunderland, United Kingdom, SR4 7TP
The Royal Free Hospital	Recruiting
London, United Kingdom, NW3 2QG
King's College Hospital	Recruiting
London, United Kingdom, SE5 9RS
Castle Hill Hospital	Recruiting
Hull, United Kingdom, HU16 5JQ
Falkirk and District Royal Infirmary	Recruiting
Falkirk, United Kingdom, FK1 5QE
Southern General Hospital	Recruiting
Glasgow, United Kingdom, G51 4TF
Whipps Cross University Hospital	Recruiting
London, United Kingdom, E11 1NR
Derriford Hospital	Recruiting
Plymouth, United Kingdom, PL6 8DH

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 CS28, 2008-004338-26 (EudraCT No)
Study First Received:	January 27, 2009
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00831233 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents

Therapeutic Uses
Goserelin
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010