Open-Label, Randomised Parallel-Group Study - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00728533

Purpose

An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Degarelix Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Rationale of the Study is to Demonstrate That Degarelix Given at Three-Month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
To evaluate pharmacokinetic response. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
To compare safety and tolerability profiles of different degarelix three-month dosing regimens. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months	Drug: Degarelix Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
2: Experimental Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.	Drug: Degarelix Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

Eligibility

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

Criteria

Inclusion Criteria:

Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
Screening PSA level of =2 ng/mL. ECOG score of =2.
Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
Serum levels of testosterone, LH, FSH, and PSA over time.
Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Plasma levels of degarelix over time.
Frequency and severity of adverse events.
Clinically significant changes in laboratory safety parameters.
Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Ferring Pharmaceuticals A/S ( Clinical R&D, Urology )
Study ID Numbers:	FE200486 CS26, 2007-006055-39
Study First Received:	January 18, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00728533
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer requiring Androgen Ablation Therapy

Study placed in the following topic categories:

Testosterone
Prostatic Diseases
Genital Neoplasms, Male
Benzocaine
Urogenital Neoplasms

Methyltestosterone
Genital Diseases, Male
Prostatic Neoplasms
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009