Skip to main content
OpenTrials
Completed

NCT Number: NCT00819156

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

Completed

Looking for future studies?

Notify Me

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

UCL Saint Luc, Brussels, Belgium

Loading trial locations.

About this study

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent prior to any study related procedures
  • Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Exclusion criteria

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
  • Hypersensitivity towards any component of degarelix or mannitol
  • Cancer disease within the last 5 years except for prostate cancer and some skin cancers
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Known hepatic disease
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier precluding adequate understanding or cooperation
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial

Treatment and study plan

degarelix

Drug

Degarelix was given as subcutaneous injections.

Other names: FE200486

Primary outcomes

  1. Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364

    Time frame: 12 months

    Number of patients who achieved a testosterone level considered a castration level.

Secondary outcomes

  1. Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28

    Time frame: Day 28 - 364

    Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.

  2. Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.

    Time frame: Day 28

    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.

  3. Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.

    Time frame: Day 3

    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.

  4. Days to 50 Percent Reduction in Prostate-Specific Antigen

    Time frame: Day 0 (post dose) to Day 364

    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.

  5. Days to 90 Percent Reduction in Prostate-Specific Antigen

    Time frame: Day 0 (post dose) to Day 364

    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.

  6. Days to Prostate-Specific Antigen Progression

    Time frame: Day 0 (post dose) to Day 364

    Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.

  7. Median Serum Testosterone Levels

    Time frame: Day 0 (Baseline), Days 1,3,7,14, and 364

  8. Median Prostate-specific Antigen Levels

    Time frame: Day 0 (Baseline), Days 3, 7, 14, and 364

  9. Median Values of Di-Hydrotestosterone

    Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  10. Median Values for Serum Luteinizing Hormone

    Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  11. Median Values for Follicle Stimulation Hormone

    Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  12. The Number of Patients With Abnormal Liver Function Tests

    Time frame: 364 days

    The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.

  13. The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight

    Time frame: Day 364

    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 8, 2009
Registry last updated
Nov 30, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.