Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

NCT00833248 | Completed Phase 3 Results

• 2 other identifiers: FE200486 CS302008-005232-33
• Study Type: interventional
• Target: 246
• Locations: 7 countries
• Sites: 66

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12

  After treatment of 4, 8, and 12 weeks compared to Baseline

• Change From Baseline in Serum Testosterone Levels During the Study

  After treatment of 4, 8, and 12 weeks compared to Baseline

• Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study

  After treatment of 4, 8, and 12 weeks compared to Baseline

• Change From Baseline in Serum Oestradiol Levels During the Study

  After treatment of 4, 8, and 12 weeks compared to Baseline

• Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit

  After treatment of 4, 8, and 12 weeks compared to Baseline

Study Arms (2)

Degarelix 240 mg/80 mg

EXPERIMENTAL

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.

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

ACTIVE COMPARATOR

On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

Drug: Goserelin; Drug: Bicalutamide

Interventions

Degarelix DRUG

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.

Also known as: FE200486, Firmagon

Degarelix 240 mg/80 mg

Goserelin DRUG

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.

Also known as: Zoladex

Goserelin (3.6 mg) + bicalutamide (50 mg)

Bicalutamide DRUG

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.

Also known as: Casodex

Goserelin (3.6 mg) + bicalutamide (50 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (66)

Alabama Research Center

Birmingham, Alabama, 35209, United States

Location

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Alaska Urological Association

Anchorage, Alaska, 99508, United States

Location

Arizona Urologic Specialists

Tuscon, Arizona, 85712, United States

Location

Orange County Urology

Lagua Hills, California, 92653, United States

Location

Tri-Valley Urology Medical Group

Murrieta, California, 92563, United States

Location

Connecticut Clinical Research Center

Middlebury, Connecticut, 06762, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

DCT -Celebration, LLC dba Discovery Clinical Trials

Celebration, Florida, 34747, United States

Location

Pinellas Urology Inc.

St. Petersburg, Florida, 33710, United States

Location

Palm Beach Urology Associates

Wellington, Florida, 33449, United States

Location

Summit Research Institute

Bloomington, Indiana, 47403, United States

Location

Northeast Indiana Research

Fort Wayne, Indiana, 46825, United States

Location

Urology Center Research Institute

Englewood, New Jersey, 07631, United States

Location

Urology Group of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Premier Medical Group of Hudson

Baldwinsville, New York, 12601, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Urology of Virginia

Norfolk, Virginia, 23502, United States

Location

Hopital Jean Minjoz

Besançon, 25000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Francois Baclesse

Caen, 14000, France

Location

CHU Henri Mondor

Créteil, 94000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

CRLC Val d'Aurelle Oncology Radiotherapy

Montpellier, CX5 34298, France

Location

Hôpital Tenon

Paris, 75000, France

Location

Hôpital Saint Louis, Radiotherapy Departement

Paris, 75010, France

Location

Clinique Francheville

Périgueux, 24000, France

Location

CHU La Milétrie, Oncology Radiotherapy

Poitiers, 86000, France

Location

Clinique Saint Brieuc

Saint-Brieuc, 22015, France

Location

Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

Saint-Herblain, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, CX 42271, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Centre de radiologie Saint Louis

Toulon, 83100, France

Location

Clinique du Parc

Toulouse, 31400, France

Location

IGR

Villejuif, 94805, France

Location

Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie

Berlin, D-12203, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, D-38126, Germany

Location

Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie

Dresden, D-01307, Germany

Location

Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie

Ulm, D-89081, Germany

Location

General University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens, "Sismanogleio", University of Athens, Marouse

Athens, 15126, Greece

Location

University General Hospital of Loannina, Medical School

Loannina, 45110, Greece

Location

University General Hospital of Patras

Pátrai, 26504, Greece

Location

Albert Schweitzer Ziekenhuis, Ioc., Dordwijk

Dordrecht, 3318 AT, Netherlands

Location

Groene Hart Ziekenhuis, urology

Gouda, 2803 HH, Netherlands

Location

Franciscus Gasthuis, Dept. urology

Rotterdam, 3045 PM, Netherlands

Location

Maastad Ziekenhuis, Ioc. Clara

Rotterdam, 3078HT, Netherlands

Location

Vlietland Ziekenhuis, Dept. urology

Schiedam, 3118 JH, Netherlands

Location

St. Elisabeth Ziekenhuis Tilburg

Tilburg, 5000 LC, Netherlands

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Fundación IVO

Valencia, 46009, Spain

Location

Kent Oncology Centre Maidstone Hospital

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

Mount Vernon Cancer Center

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Oncology Royal United Hospital Bath NHS Trust

Bath, BA1 3NG, United Kingdom

Location

Addenbrooke's Hospital, Oncology Centre

Cambridge, CB2 0QQ, United Kingdom

Location

St. James' University Hospital

Leeds, LS9 7TF, United Kingdom

Location

The Royal Marsden NHS, Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Charing Cross Hospital

London, W6 8FR, United Kingdom

Location

Northern Centre for Cancer Treatment, Newcastle General Hospital

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre

Southhampton, SO16 6YD, United Kingdom

Location

Velindre Hospital, Cardiff University

Whitchurch, CF14 2TL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34350976 DERIVED

• 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.

  PMID: 23257248 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Goserelin; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Ferring Pharmaceuticals
• Organization: Clinical Development Support

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2012
• Results First Posted: September 27, 2012

Record last verified: 2012-09

Locations

NL (6); ES (4); GB (10); FR (19); US (19); DE (4); GR (4)