Clinical trial NCT00833248: Neoadjuvant 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 Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 246
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 phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


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
* Patients who are lymph node positive or have other metastatic disease
* Use of urethral catheter
* Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* 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.
* 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)
* 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 Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
timeFrame: After treatment of 12 weeks compared to Baseline
measure: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
timeFrame: After treatment of 12 weeks compared to Baseline
Secondary outcomes:
measure: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Change From Baseline in Serum Testosterone Levels During the Study
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Change From Baseline in Serum Oestradiol Levels During the Study
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: Birmingham
country: United States
facility: Alabama Research Center
state: Alabama
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Urological Association
state: Alaska
city: Tuscon
country: United States
facility: Arizona Urologic Specialists
state: Arizona
city: Lagua Hills
country: United States
facility: Orange County Urology
state: California
city: Murrieta
country: United States
facility: Tri-Valley Urology Medical Group
state: California
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Celebration
country: United States
facility: DCT -Celebration, LLC dba Discovery Clinical Trials
state: Florida
city: St. Petersburg
country: United States
facility: Pinellas Urology Inc.
state: Florida
city: Wellington
country: United States
facility: Palm Beach Urology Associates
state: Florida
city: Bloomington
country: United States
facility: Summit Research Institute
state: Indiana
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Englewood
country: United States
facility: Urology Center Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico
state: New Mexico
city: Columbia
country: United States
facility: Premier Medical Group of Hudson
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Norfolk
country: United States
facility: Urology of Virginia
state: Virginia
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux Cedex
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre Francois Baclesse
city: Creteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille, Cedex 5
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: CRLC Val d'Aurelle Oncology Radiotherapy
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Saint Louis, Radiotherapy Departement
city: Perigueux
country: France
facility: Clinique Francheville
city: Poitiers
country: France
facility: CHU La Milétrie, Oncology Radiotherapy
city: Saint Herblain Cedex
country: France
facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: St Brieuc Cedex
country: France
facility: Clinique Saint Brieuc
city: Strassbourg
country: France
facility: Centre Paul Strauss
city: Toulon
country: France
facility: Centre de radiologie Saint Louis
city: Toulouse
country: France
facility: Clinique du Parc
city: Villejuif
country: France
facility: IGR
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital of Athens, "Sismanogleio", University of Athens, Marouse
city: Loannina
country: Greece
facility: University General Hospital of Loannina, Medical School
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, Ioc., Dordwijk
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis, urology
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis, Dept. urology
city: Rotterdam
country: Netherlands
facility: Maastad Ziekenhuis, Ioc. Clara
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis, Dept. urology
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis Tilburg
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Fundación IVO
city: Maidstone
country: United Kingdom
facility: Kent Oncology Centre Maidstone Hospital
state: Kent
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Center
state: Middlesex
city: Bath
country: United Kingdom
facility: Oncology Royal United Hospital Bath NHS Trust
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Oncology Centre
city: Leeds
country: United Kingdom
facility: St. James' University Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS, Foundation Trust
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment, Newcastle General Hospital
city: Southhampton
country: United Kingdom
facility: Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre
city: Whitchurch
country: United Kingdom
facility: Velindre Hospital, Cardiff University
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.
citation: Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.