Open-Label, Randomised Parallel-Group Study

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Androgens

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.