Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833248
• Other study ID #: FE200486 CS30
• Secondary ID: 2008-005232-33
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2009
• Last updated: September 27, 2012
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Greece: National Organization of MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
• Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
• Bicalutamide
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.

Locations

Country	Name	City	State
France	Hopital Jean Minjoz	Besancon
France	Institut Bergonié	Bordeaux Cedex
France	Centre Francois Baclesse	Caen
France	CHU Henri Mondor	Creteil
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Hopital de la Timone	Marseille, Cedex 5
France	CRLC Val d'Aurelle Oncology Radiotherapy	Montpellier
France	Hôpital Saint Louis, Radiotherapy Departement	Paris
France	Hôpital Tenon	Paris
France	Clinique Francheville	Perigueux
France	CHU La Milétrie, Oncology Radiotherapy	Poitiers
France	Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau	Saint Herblain Cedex
France	Institut de Cancérologie de la Loire	Saint Priest en Jarez
France	Clinique Saint Brieuc	St Brieuc Cedex
France	Centre Paul Strauss	Strassbourg
France	Centre de radiologie Saint Louis	Toulon
France	Clinique du Parc	Toulouse
France	IGR	Villejuif
Germany	Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie	Berlin
Germany	Städtisches Klinikum Braunschweig	Braunschweig
Germany	Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie	Dresden
Germany	Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie	Ulm
Greece	General University Hospital of Alexandroupolis	Alexandroupolis
Greece	General Hospital of Athens, "Sismanogleio", University of Athens, Marouse	Athens
Greece	University General Hospital of Loannina, Medical School	Loannina
Greece	University General Hospital of Patras	Patras
Netherlands	Albert Schweitzer Ziekenhuis, Ioc., Dordwijk	Dordrecht
Netherlands	Groene Hart Ziekenhuis, urology	Gouda
Netherlands	Franciscus Gasthuis, Dept. urology	Rotterdam
Netherlands	Maastad Ziekenhuis, Ioc. Clara	Rotterdam
Netherlands	Vlietland Ziekenhuis, Dept. urology	Schiedam
Netherlands	St. Elisabeth Ziekenhuis Tilburg	Tilburg
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d´Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Fundación IVO	Valencia
United Kingdom	Oncology Royal United Hospital Bath NHS Trust	Bath
United Kingdom	Addenbrooke's Hospital, Oncology Centre	Cambridge
United Kingdom	St. James' University Hospital	Leeds
United Kingdom	Charing Cross Hospital	London
United Kingdom	The Royal Marsden NHS, Foundation Trust	London
United Kingdom	Kent Oncology Centre Maidstone Hospital	Maidstone	Kent
United Kingdom	Northern Centre for Cancer Treatment, Newcastle General Hospital	Newcastle upon Tyne
United Kingdom	Mount Vernon Cancer Center	Northwood	Middlesex
United Kingdom	Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre	Southhampton
United Kingdom	Velindre Hospital, Cardiff University	Whitchurch
United States	Urology Group of New Mexico	Albuquerque	New Mexico
United States	Alaska Urological Association	Anchorage	Alaska
United States	South Florida Medical Research	Aventura	Florida
United States	Alabama Research Center	Birmingham	Alabama
United States	Summit Research Institute	Bloomington	Indiana
United States	DCT -Celebration, LLC dba Discovery Clinical Trials	Celebration	Florida
United States	Premier Medical Group of Hudson	Columbia	New York
United States	Urology Center Research Institute	Englewood	New Jersey
United States	Northeast Indiana Research	Fort Wayne	Indiana
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Orange County Urology	Lagua Hills	California
United States	Connecticut Clinical Research Center	Middlebury	Connecticut
United States	Tri-Valley Urology Medical Group	Murrieta	California
United States	Urology Associates	Nashville	Tennessee
United States	University Urology Associates	New York	New York
United States	Urology of Virginia	Norfolk	Virginia
United States	Pinellas Urology Inc.	St. Petersburg	Florida
United States	Arizona Urologic Specialists	Tuscon	Arizona
United States	Palm Beach Urology Associates	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Greece,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)	TRUS is a method of measuring the size of the prostate.	After treatment of 12 weeks compared to Baseline	No
Primary	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)	TRUS is a method of measuring the size of the prostate.	After treatment of 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12	The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.	After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Serum Testosterone Levels During the Study		After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study		After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Serum Oestradiol Levels During the Study		After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit	The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').	After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	Baseline to 12 weeks of treatment	No
Secondary	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.	Baseline to 12 weeks of treatment	No