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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00819156 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS12
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
189 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
8 countries

Belgium, Germany, Hungary, Netherlands, Poland, Romania, Russia, South Africa

Start
Feb 2004
Primary completion
Jun 2005
Completion
Sept 2005
First posted
8 Jan 2009 (estimated)
Last update posted
30 Nov 2023
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 2

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

    NCT00819156

    Feb 2004 to Sept 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • degarelixDrug

Arms6

  • Experimental

    Degarelix 200/80

    Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

  • Experimental

    Degarelix 200/120

    Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

  • Experimental

    Degarelix 200/160

    Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

  • Experimental

    Degarelix 240/80

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.

  • Experimental

    Degarelix 240/120

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.

  • Experimental

    Degarelix 240/160

    Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 12 months

    Registry description

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

Secondary outcomes(13)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 12 months

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

GroupValue (participants)
Degarelix 200/8017
Degarelix 200/12021
Degarelix 200/16026
Degarelix 240/8027
Degarelix 240/12027
Degarelix 240/16023
Secondary and other outcome results(7)
Secondary outcomeNumber· Day 28 - 364

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

GroupValue (participants)
Maintenance Dose of 80 Milligram Per Cycle44
Maintenance Dose of 120 Milligram Per Cycle48
Maintenance Dose of 160 Milligram Per Cycle49
Secondary outcomeNumber· Day 28

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

GroupValue (participants)
Degarelix 200/8021
Degarelix 200/12029
Degarelix 200/16031
Degarelix 240/8029
Degarelix 240/12031
Degarelix 240/16027
Secondary outcomeNumber· Day 3

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

GroupValue (participants)
Degarelix 200/8025
Degarelix 200/12030
Degarelix 200/16027
Degarelix 240/8028
Degarelix 240/12030
Degarelix 240/16028
Secondary outcomeMedian· Day 0 (post dose) to Day 364

Days to 50 Percent Reduction in Prostate-Specific Antigen

GroupValue (days)
Degarelix 200/8014
Degarelix 200/12014
Degarelix 200/16014
Degarelix 240/8014
Degarelix 240/12014
Degarelix 240/16014
Secondary outcomeMedian· Day 0 (post dose) to Day 364

Days to 90 Percent Reduction in Prostate-Specific Antigen

GroupValue (days)
Degarelix 200/8056
Degarelix 200/12056
Degarelix 200/16056
Degarelix 240/8056
Degarelix 240/12056
Degarelix 240/16056
Secondary outcomeMedian· Day 0 (post dose) to Day 364

Days to Prostate-Specific Antigen Progression

GroupValue (days)
Degarelix 200/120224
Degarelix 200/160308
Degarelix 240/80280
Degarelix 240/120224
Degarelix 240/160140
Secondary outcomeMedian· Day 0 (Baseline), Days 1,3,7,14, and 364

Median Serum Testosterone Levels

GroupValue (nanogram/milliliter)
Degarelix 200/804.47
Degarelix 200/1203.93
Degarelix 200/1604.79
Degarelix 240/804.28
Degarelix 240/1204.07
Degarelix 240/1603.88

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 200/80Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.–3 / ?17 / ?
Degarelix 200/120Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.–6 / ?21 / ?
Degarelix 200/160Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.–4 / ?24 / ?
Degarelix 240/80Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.–4 / ?19 / ?
Degarelix 240/120Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.–6 / ?23 / ?
Degarelix 240/160Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.–4 / ?20 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

7 results

Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer.

Van Poppel et al. 2008European urologycited by 91

PMID 18538469DOI 10.1016/j.eururo.2008.04.065PUB-18538469

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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