Open-Label, Randomised Parallel-Group Study

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00728533
• Other study ID #: FE200486 CS26
• Secondary ID: 2007-006055-39
• Status: Withdrawn
• Phase: Phase 3
• First received: January 18, 2008
• Last updated: March 17, 2011

Study information

• Verified date: March 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
• Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.		3-month	Yes
Secondary	To evaluate pharmacokinetic response.		3-month	Yes
Secondary	To compare safety and tolerability profiles of different degarelix three-month dosing regimens.		3-month	Yes