Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00833248

Purpose

The purpose of this trial is 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 are 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, hormone therapy will be given for three months and patients will be randomly selected (like flipping a coin) to receive either Degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide) The prostate size will be measured by ultra sound at the beginning and at the end of the trial and patients will be required to come to the clinic for 5 or 6 visits during the three months.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Mean percentage reduction in prostate volume [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After 4, 8 and 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
Evaluate changes in the concentration of testosterone in the serum [ Time Frame: After 4, 8 and 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
Evaluate changes in the concentration of Prostate Specific Antigen (PSA) in the serum [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
Evaluate changes in the concentration of oestradiol in the serum (blood) [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
Evaluate patients' Quality of life based on questionnaire [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
Safety (Adverse events and laboratory values) [ Time Frame: As applicable ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Degarelix
2: Active Comparator	Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833248

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

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Locations

France
CRLC Val d'Aurelle Oncology Radiotherapy	Recruiting
Montpellier, France, CX5 34298
Hôpital Saint Louis, Radiotherapy Departement	Recruiting
Paris, France, 75010
CHU La Milétrie, Oncology Radiotherapy	Recruiting
Poitiers, France, 86000
CHU Henri Mondor	Recruiting
Creteil, France, 94000
Centre Francois Baclesse	Recruiting
Caen, France, 14000
Clinique Francheville	Recruiting
Perigueux, France, 24000
Clinique Saint Brieuc	Recruiting
St Brieuc Cedex, France, 22015
Institut Bergonié	Recruiting
Bordeaux Cedex, France, 33076
Clinique du Parc	Recruiting
Toulouse, France, 31400
Institut de Cancérologie de la Loire	Recruiting
Saint Priest en Jarez, France, CX 42271
Centre Leon Berard	Recruiting
Lyon, France, 69008
Hôpital Tenon	Recruiting
Paris, France, 75000
IGR	Recruiting
Villejuif, France, 94805
Centre Paul Strauss	Recruiting
Strassbourg, France, 67085
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Centre de radiologie Saint Louis	Recruiting
Toulon, France, 83100
Hopital Jean Minjoz	Recruiting
Besancon, France, 25000
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau	Recruiting
Saint Herblain Cedex, France
Hopital de la Timone	Recruiting
Marseille, Cedex 5, France, 13385
Germany
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie	Recruiting
Ulm, Germany, D-89081
Städtisches Klinikum Braunschweig	Recruiting
Braunschweig, Germany, D-38126
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie	Recruiting
Berlin, Germany, D-12203
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie	Recruiting
Dresden, Germany, D-01307
Greece
General Hospital of Athens, "Sismanogleio", University of Athens, Marouse	Recruiting
Athens, Greece, 15126
University General Hospital of Loannina, Medical School	Recruiting
Loannina, Greece, 45110
University General Hospital of Patras	Recruiting
Patras, Greece, 26504
General University Hospital of Alexandroupolis	Recruiting
Alexandroupolis, Greece, 68100
Netherlands
Franciscus Gasthuis, Dept. urology	Recruiting
Rotterdam, Netherlands, 3045 PM
Vlietland Ziekenhuis, Dept. urology	Recruiting
Schiedam, Netherlands, 3118 JH
Groene Hart Ziekenhuis, urology	Recruiting
Gouda, Netherlands, 2803 HH
Maastad Ziekenhuis, Ioc. Clara	Recruiting
Rotterdam, Netherlands, 3078HT
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk	Recruiting
Dordrecht, Netherlands, 3318 AT
Spain
Fundación IVO	Recruiting
Valencia, Spain, 46009
Hospital de la Santa Creu i Sant Pau	Recruiting
Barcelona, Spain, 08025
Hospital Universitari Vall d´Hebron	Recruiting
Barcelona, Spain, 08035
United Kingdom
Velindre Hospital, Cardiff University	Recruiting
Whitchurch, United Kingdom, CF14 2TL
Charing Cross Hospital	Recruiting
London, United Kingdom, W6 8FR
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre	Recruiting
Southhampton, United Kingdom, SO16 6YD
Addenbrooke's Hospital, Oncology Centre	Recruiting
Cambridge, United Kingdom, CB2 0QQ
Northern Centre for Cancer Treatment, Newcastle General Hospital	Recruiting
Newcastle upon Tyne, United Kingdom, NE4 6BE
St. James' University Hospital	Recruiting
Leeds, United Kingdom, LS9 7TF
The Royal Marsden NHS, Foundation Trust	Recruiting
London, United Kingdom, SW3 6JJ
Oncology Royal United Hospital Bath NHS Trust	Recruiting
Bath, United Kingdom, BA1 3NG
United Kingdom, Kent
Kent Oncology Centre Maidstone Hospital	Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
United Kingdom, Middlesex
Mount Vernon Cancer Center	Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS30, 2008-005232-33 (EudraCT No)
Study First Received:	January 30, 2009
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00833248 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Greece: National Organization of Medicines; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 27, 2009