Clinical trial NCT00831233: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
timeFrame: After treatment of 12 weeks compared to Baseline
Secondary outcomes:
measure: Change From Baseline in Total IPSS at Weeks 4 and 8
timeFrame: After treatment of 4 and 8 weeks compared to Baseline
measure: Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit
timeFrame: After treatment of 4, 8 and 12 weeks compared to Baseline
measure: Change From Baseline in Residual Volume (Vresidual) at Each Visit
timeFrame: After treatment of 4, 8 and 12 weeks compared to Baseline
measure: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12
timeFrame: After 12 weeks treatment compared to Baseline
measure: Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit
timeFrame: After treatment of 4, 8 and 12 weeks compared to Baseline
measure: Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit
timeFrame: After treatment of 4, 8 and 12 weeks compared to Baseline
measure: Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
timeFrame: After treatment of 4, 8 and 12 weeks compared to Baseline
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Baseline to 12 weeks of treatment
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: Baseline to 12 weeks of treatment
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Facharztpraxis für Urologie
city: Borken
country: Germany
facility: Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Fürth
country: Germany
facility: Euromed Clinic
city: Hamburg
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Köln
country: Germany
facility: Gemeinschaftspraxis
city: Leipzig
country: Germany
facility: VITURO Gesellschaft für Klinische Studien
city: Offenbach
country: Germany
facility: Klinikum Offenbach GmbH
city: Planegg
country: Germany
facility: Urologische Klinik Planegg
city: Wuppertal
country: Germany
facility: Wuppertaler Gemeinschaftspraxis
city: Alcalá de Henares-Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcón
city: Barcelona
country: Spain
facility: Fundación Puigvert
city: Bilbao (Bizkaia)
country: Spain
facility: Hospital de Basurto
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico Universitario S. Carlos
city: Majadahonda, Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Manacor
country: Spain
facility: Hospital Manacor
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hospital Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
city: Bristol
country: United Kingdom
facility: United Bristol Healthcare NHSTrust Bristol Royal Infirmary
city: Falkirk
country: United Kingdom
facility: Falkirk and District Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Sheffield South
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.
citation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.