Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00801242

Purpose

The purpose of this trial is to see how well a new trial drug (degarelix) works and how safe it is when given for 7 months. For patients participating, their level of PSA (prostate specific antigen) will be measured in a blood sample, and when this level rises above a certain level they will receive treatment for the prostate cancer again. The patients will come to the clinic at monthly intervals for the first 7 months and after this they will be followed bi-monthly for a period of up to 24 months.

Condition	Intervention	Phase
Prostate Cancer	Drug: degarelix	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One Cycle in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
degarelix: Experimental	Drug: degarelix One starting dose of 240 mg; followed by monthly maintenance doses of 80 mg for 7 months

Eligibility

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

Criteria

Inclusion Criteria:

Has given written informed consent before any trial-related activity is performed.
Has prostate cancer, and is in need of this type of treatment.

Exclusion Criteria:

Has had previous or is currently under hormonal treatment of prostate cancer.
Is considered to be candidate for radical prostatectomy or radiotherapy.
Has a history of severe uncontrolled asthma and/or other severe allergic reactions.
Has hypersensitivity towards any component of degarelix.
Has had cancer within the last five years except prostate cancer and some types of skin cancer.
Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801242

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Show 52 Study Locations

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 CS29, EudraCT No: 2008-003931-19
Study First Received:	December 2, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00801242 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: National Consultative Ethics Committee for Health and Life Sciences; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica; Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009