Open-Label, Randomised Parallel-Group Study

Ferring

Status and phase: Withdrawn; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728533

FE200486 CS26

2007-006055-39

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

1

Experimental group

Description:

* 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

Treatment:

Drug: Degarelix

Drug: Degarelix

2

Experimental group

Description:

* 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.

Treatment:

Drug: Degarelix

Drug: Degarelix