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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

Overview

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

United States, Canada

Start
Feb 2004
Primary completion
Aug 2005
Completion
Aug 2005
First posted
1 Jul 2005 (estimated)
Last update posted
19 Dec 2011 (estimated)
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

    A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

    NCT00116779

    Feb 2004 to Aug 2005

Registry summary

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

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

Interventions

  • DegarelixDrug

Arms2

  • Experimental

    Degarelix 60mg

    Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.

  • Experimental

    Degarelix 80mg

    Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Day 28 to Day 364

    Registry description

    Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364

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

    Time frame · Day 28 - Day 364

    Registry description

    Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.

Secondary outcomes(11)
  1. Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

    Time frame · Day 3

    Registry description

    Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

  2. Days to 50 Percent and 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 50 percent and 90 percent of the baseline value.

  3. 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 2 weeks apart.

  4. Median Di-Hydrotestosterone Levels At Various Study Timepoints

    Time frame · Baseline, Days 1, 3, 7, 14

    Registry description

    Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

  5. Median Prostate-Specific Antigen Values at Various Study Timepoints

    Time frame · Baseline, Days 3, 14, 28, 84, 364

    Registry description

    Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

  6. Median Luteinizing Hormone Levels at Various Study Timeframes

    Time frame · Baseline, Days 1, 3, 7, 14

    Registry description

    Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

  7. Median Testosterone Levels at Various Days During the Study

    Time frame · Baseline, Days 1,3,7,14,364

    Registry description

    Testosterone levels at baseline and days 1, 3, 7, 14 and 364

  8. Number of Participants With Abnormal Alanine Aminotransferase Values

    Time frame · Day 1 through day 364

    Registry description

    Participants whose alanine aminotransferase values were at levels above the normal range.

  9. Number of Participants With Abnormal Aspartate Aminotransferase Values

    Time frame · Day 1 - 364

    Registry description

    Participants with aspartate aminotransferase values that were above the normal range.

  10. Number of Participants With Abnormal Total Bilirubin Values

    Time frame · Day 1 - 364

    Registry description

    Participants with abnormal total bilirubin values

  11. Participants 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 participants 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· Day 28 to Day 364

Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

GroupValue (participants)
Degarelix 60mg42
Degarelix 80mg41
Primary outcomeNumber· Day 28 - Day 364

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

GroupValue (participants)
Degarelix 60mg42
Degarelix 80mg41
Secondary and other outcome results(6)
Secondary outcomeNumber· Day 3

Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

GroupValue (participants)
Degarelix 60mg54
Degarelix 80mg56
Secondary outcomeMedian· Day 0 (post dose) to Day 364

Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

GroupValue (days)
Degarelix 60mg14
Degarelix 80mg14
Secondary outcomeMedian· Day 0 (post dose) to Day 364

Days to Prostate-Specific Antigen Progression

GroupValue (days)
Degarelix 60mg196
Degarelix 80mg154
Secondary outcomeMedian· Baseline, Days 1, 3, 7, 14

Median Di-Hydrotestosterone Levels At Various Study Timepoints

GroupValue (picogram / milliliter)
Degarelix 60mg360
Degarelix 80mg350
Secondary outcomeMedian· Baseline, Days 3, 14, 28, 84, 364

Median Prostate-Specific Antigen Values at Various Study Timepoints

GroupValue (nanogram / milliliter)
Degarelix 60mg12.7
Degarelix 80mg13.7
Secondary outcomeMedian· Baseline, Days 1, 3, 7, 14

Median Luteinizing Hormone Levels at Various Study Timeframes

GroupValue (international units / liter)
Degarelix 60mg5.28
Degarelix 80mg5.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 60mgInitial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.–9 / ?55 / ?
Degarelix 80mgInitial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.–6 / ?52 / ?

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

A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America.

Gittelman et al. 2008The Journal of urologycited by 67

PMID 18801505DOI 10.1016/j.juro.2008.07.033PUB-18801505

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Each patient must meet the following inclusion criteria before entry into the study. * Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient). * Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention. * Male patient aged 18 years or over. * Has a baseline testosterone above the lower limit of normal range. * Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2. * Has a PSA value of greater than or equal to 2ng/mL. Exclusion Criteria: Any patient meeting one or more of the following exclusion criteria will not be entered into the study. * Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit. * Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function. * Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit. * Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema. * Has hypersensitivity towards any component of the investigational products (degarelix or mannitol). * Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. * Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit. * Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study. * Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results. * Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator. * Has a mental incapacity or language barriers precluding adequate understanding or cooperation. * Has received an investigational drug within the last 12 weeks preceding Screening Visit. * Has previously participated in any degarelix study

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