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

Sponsor:	Ferring Pharmaceuticals
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	246
Study Start Date:	April 2009
Study Completion Date:	October 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix	Drug: Degarelix Treatment with Degarelix for 3 months Other Names: degarelix acetate Firmagon
Active Comparator: Goserelin and bicalutamide	Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®) Treatment for three months Other Names: Zoladex® 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

Show 66 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00833248 History of Changes
Other Study ID Numbers:	FE200486 CS30, 2008-005232-33 (EudraCT No)
Study First Received:	January 30, 2009
Last Updated:	December 8, 2011
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); United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Bicalutamide
Androgens

Goserelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012