Open-Label, Randomised Parallel-Group Study

Phase 3

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00728533
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Degarelix	* 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.
1	Degarelix	* 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

Primary Outcome Measures

Name	Time	Method
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.	3-month

Secondary Outcome Measures

Name	Time	Method
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.	3-month
To evaluate pharmacokinetic response.	3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.	3-month