Open-Label, Randomised Parallel-Group Study

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.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00728533

Enrollment

Registered

2008-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2011-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer requiring Androgen Ablation Therapy

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.

Interventions

DRUGDegarelix

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026