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Completed

NCT Number: NCT00468286

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site, Surrey, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

degarelix

Drug

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.

Primary outcomes

  1. 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

  1. Serum Levels of Testosterone Over Time

    Time frame: 1 year

  2. Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364

    Time frame: 1 year

    Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.

  3. Probability of no PSA Failure

    Time frame: 1 year

    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).

  4. Serum Levels of PSA Over Time

    Time frame: 1 year

  5. Serum Levels of Follicle Stimulating Hormone (FSH) Over Time

    Time frame: 1 year

  6. Serum Levels of Luteinizing Hormone (LH) Over Time

    Time frame: 1 year

  7. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    Time frame: Baseline up to 1 year

    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.

  8. Liver Function Tests

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 2, 2007
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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