Open-Label, Randomised Parallel-Group Study

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Degarelix	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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.

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; 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.
Experimental: 2; 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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:	Clinical Development Support	Ferring Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00728533 History of Changes
Other Study ID Numbers:	FE200486 CS26; 2007-006055-39
First Posted:	August 6, 2008
Last Update Posted:	March 18, 2011
Last Verified:	March 2011

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer requiring Androgen Ablation Therapy

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male	Prostatic Diseases; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs