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Clinical Trials/NCT00468286
NCT00468286CompletedPhase 2

An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Ferring Pharmaceuticals26 sites in 5 countries133 target enrollmentStarted: May 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
133
Locations
26
Primary Endpoint
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364

Study Overview

Brief Summary

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Detailed Description

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients, aged 18 years or older, with 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.
  • Eastern Cooperative Oncology Group (ECOG) score of ≤
  • Screening prostate-specific antigen (PSA) level ≥ ng/mL.

Arms & Interventions

A

Experimental

Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.

Intervention: Degarelix (Drug)

B

Experimental

Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.

Intervention: Degarelix (Drug)

Outcomes

Primary Outcomes

Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364

Time Frame: 1 year

Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.

Secondary Outcomes

  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight(Baseline up to 1 year)
  • Serum Levels of Testosterone Over Time(1 year)
  • Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364(1 year)
  • Serum Levels of PSA Over Time(1 year)
  • Probability of no PSA Failure(1 year)
  • Serum Levels of Luteinizing Hormone (LH) Over Time(1 year)
  • Liver Function Tests(1 year)
  • Serum Levels of Follicle Stimulating Hormone (FSH) Over Time(1 year)

Investigators

Sponsor Class
Industry

Study Sites (26)

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