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Brief Title: Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
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
Study ID: NCT00831233
Brief Summary: The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were 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 was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Facharztpraxis für Urologie, Bamberg, , Germany
Gemeinschaftspraxis, Borken, , Germany
Universitätsklinikum Dresden, Dresden, , Germany
Euromed Clinic, Fürth, , Germany
Urologische Gemeinschaftspraxis, Hamburg, , Germany
Gemeinschaftspraxis, Köln, , Germany
VITURO Gesellschaft für Klinische Studien, Leipzig, , Germany
Klinikum Offenbach GmbH, Offenbach, , Germany
Urologische Klinik Planegg, Planegg, , Germany
Wuppertaler Gemeinschaftspraxis, Wuppertal, , Germany
Hospital Universitario Principe de Asturias, Alcalá de Henares-Madrid, , Spain
Fundacion Hospital Alcorcón, Alcorcon, , Spain
Fundación Puigvert, Barcelona, , Spain
Hospital de Basurto, Bilbao (Bizkaia), , Spain
Complejo Hospitalario Universitario A Coruña, Coruña, , Spain
Hospital universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico Universitario S. Carlos, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, , Spain
Hospital Manacor, Manacor, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Santiago de Compostela, Santiago de Compostela, , Spain
Hospital Virgen Macarena, Sevilla, , Spain
Hospital Xeral de Vigo, Vigo, , Spain
United Bristol Healthcare NHSTrust Bristol Royal Infirmary, Bristol, , United Kingdom
Falkirk and District Royal Infirmary, Falkirk, , United Kingdom
Southern General Hospital, Glasgow, , United Kingdom
Castle Hill Hospital, Hull, , United Kingdom
Whipps Cross University Hospital, London, , United Kingdom
The Royal Free Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Royal Hallamshire Hospital, Sheffield South, Sheffield, , United Kingdom
Sunderland Royal Hospital, Sunderland, , United Kingdom
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR