Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00468286
First received: April 13, 2007
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.


Secondary Outcome Measures:
  • Serum Levels of Testosterone Over Time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.

  • Probability of no PSA Failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).

  • Serum Levels of PSA Over Time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum Levels of Follicle Stimulating Hormone (FSH) Over Time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum Levels of Luteinizing Hormone (LH) Over Time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline up to 1 year ] [ Designated as safety issue: No ]
    This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.

  • Liver Function Tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.


Enrollment: 133
Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Drug: Degarelix

Experimental

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.

Drug: Degarelix

Experimental

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.

Experimental: B
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.
Drug: Degarelix

Experimental

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion / 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 ≤2.
  • Screening prostate-specific antigen (PSA) level ≥ ng/mL.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468286

  Show 29 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468286     History of Changes
Other Study ID Numbers: FE200486 CS18
Study First Received: April 13, 2007
Results First Received: February 8, 2011
Last Updated: March 21, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Romania: Ministry of Public Health
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Czech Republic: Ethics Committee
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014