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.
Overview
- Phase
- Phase 3
- Intervention
- Degarelix
- Conditions
- Prostate Cancer
- Sponsor
- Ferring Pharmaceuticals
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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 =
- •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
- •Secondary endpoints:
- •Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day
- •Serum levels of testosterone, LH, FSH, and PSA over time.
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Degarelix
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.
Intervention: Degarelix
Outcomes
Primary Outcomes
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 Outcomes
- 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)